CardioGen-82 (Rubidium Rb 82 Generator) INFUSION SYSTEM ... · date of issue: february - 2015 page...

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 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.


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

3. SYSTEM SPECIFICATIONS 28

4. SYSTEM OPERATION 32 4.1 INTRODUCTION 32 4.2 THE DISPLAY/CONTROL PANEL 32 4.2.1 POWER ON/OFF SWITCH 32 4.2.2 EMERGENCY STOP/ABORT SWITCH 32 4.2.3 MODE SWITCH 33 4.2.4 MODE DISPLAY 33 4.2.5 INJECT START/STOP SWITCH 35 4.2.6 PURGE SWITCH 35 4.2.7 REFILL SWITCH 35 4.2.8 FLOW RATE SWITCH 35 4.2.9 ELUTION VOLUME DISPLAY AND LIMIT SWITCH 35 4.2.10 PATIENT VOLUME DISPLAY AND LIMIT SWITCH 36 4.2.11 PATIENT DOSE DISPLAY AND LIMIT SWITCH 36 4.2.12 DOSE RATE DISPLAY AND THRESHOLD SWITCH 36 4.2.13 PUMP LIMIT INDICATOR LIGHT 36 4.2.14 HIGH PRESSURE INDICATOR LIGHT 36 4.2.15 VALVE FAILURE INDICATOR LIGHT 37 4.2.16 AC MAIN INDICATOR LIGHT 37 4.3 THE CALIBRATION FACTOR SWITCH 37 4.4 SYSTEM ACTIVATION 37 4.5 PUMP REFILL OPERATION 38 4.6 PURGE MODES 38 4.7 AUTOMATIC INFUSION MODE 40 SUMMARY OF THE AUTOMATIC INFUSION OPERATION 40 4.7.1 DESCRIPTION 43 4.7.2 REPORT PRINTOUT 44

5. OPERATING PROCEDURE 45 5.1 GENERAL NOTES 45


5.2 CARDIOGEN-82 GENERATOR AND STERILE COMPONENTS 45 5.3 CARDIOGEN-82 INFUSION SYSTEM PREPARATION 46 5.4 INSTALLATION OF THE SYRINGE PUMP COMPONENTS 46 5.4.1 PUMP SYRINGE INSTALLATION (PUMP SYRINGE PKG. #1) 46 5.4.2 PRESSURE SENSOR SYRINGE INSTALLATION (INLET ASSEMBLY PKG. #2) 46 5.4.3 PUMP COVER INSTALLATION 47 5.5 CARDIOGEN-82 GENERATOR INLET ASSEMBLY PACKAGE 47 5.5.1 PRESSURE SENSOR LINE INSTALLATION 47 5.5.2 GENERATOR INLET LINE INSTALLATION 47 5.5.3 GENERATOR INLET LINE STERILIZING FILTER INSTALLATION 47 5.6 CARDIOGEN-82 GENERATOR OUTLET ASSEMBLY (PKG. #3) 48 5.6.1 DIVERGENCE VALVE INSTALLATION 48 5.6.2 GENERATOR OUTLET LINE INSTALLATION 48 5.6.3 GENERATOR WASTE LINE INSTALLATION 48 5.6.4 GENERATOR WASTE LINE TO WASTE SHIELD 48 5.6.5 WASTE BOTTLE PREPARATION AND STERILIZING FILTER INSTALLATION 49 5.7 PATIENT ADMINISTRATION SET INSTALLATION 51 5.8 SALINE SUPPLY INSTALLATION 51 5.9 CARDIOGEN-82 GENERATOR INSTALLATION 51 5.9.1. INSTALLATION PREPARATION 51 5.9.2. CARDIOGEN-82 GENERATOR INSTALLATION 51 5.10 PURGE OPERATION 52 5.10.1 SYRINGE FILLING 52 5.10.2 WASTE LINE PURGING 52 5.10.3 PRESSURE SENSOR LINE 52 5.10.4 PATIENT ADMINISTRATION SET PURGING 52 5.10.5 VOLUMETRIC FLOW RATE VERIFICATION 53 5.11 PATIENT ADMINISTRATION 53

CARDIOGEN-82 (RUBIDIUM 82) GENERATOR - SR-82/85 TESTING

INSTRUCTIONAL WORKSHEET 57

CARDIOGEN-82 INFUSION SYSTEM-CALIBRATION DATA SHEET 61

6. TROUBLESHOOTING GUIDE 65

7. CONTACT INFORMATION 88

8. CARDIOGEN-82® INFUSION SYSTEM SUPPLIES 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


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 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


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


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.


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.


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.


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.


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.


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 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 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


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.


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.


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.


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.

Immunity test IEC 60601 test

level Compliance

level Electromagnetic environment – guidance

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2,5

GHz

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.


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.


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


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


Radioactive Hazard:

GENERATOR

SHIELD

Radioactive Hazard:

VALVE SHIELD

Radioactive Hazard:

TUBING SHIELD


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.


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)


Figure 2. 1 CardioGen-82 Infusion System Diagram

Figure 2. 2 CardioGen-82 Infusion System Photograph


Figure 2. 3 CardioGen-82 Infusion System Fluid-System Diagram


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.


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)

Rb-82 Delivery

Accuracy

(Generator Sr-82 Activity 30-120 mCi, Flow Rate 50mL/min) mCi, Flow Rate 50 mL/min)

Generator Activity Accuracy

>40 mCi +/- 10%

20 - 40 mCi +/- 10%

10 - 20 mCi +/- 15%

5 - 10 mCi +/- 20%

Patient Volume

Delivery Accuracy

+0 mL / -5 mL

Automatic Infusion

Report

The system printer prepares a detailed report following every

automatic infusion. This report lists all system settings,

measured infusion volumes and activities, and a history (in one-

second intervals) of activity seen at the detector and patient port.

Additionally, any error conditions are listed if an automatic

infusion is unable to start or is terminated due to an error

condition. Data identical to the system printout is provided on

the RS-232C port.


SPECIAL SYSTEM MONITORING FUNCTIONS

System Pressure 90 psig (+/- 5 psig) pressure limit sensor is provided

along with a second, redundant pressure limit of 100

psig (+/- 10 psig) provided by the syringe pump.

Valve Operation Valve position is continuously monitored.

Additionally, the valve must transition between

waste and patient positions in less than 2 seconds or

an error will be detected.

Pump Limit Syringe pump limits, both refill (nom. 128 mL) and

pump limits (nom. 15 mL) are monitored.

Valve Shield The valve shield is monitored to detect if it is open.

Additionally, the valve shield remains locked for

any purge or infusion operation and does not unlock

until the detector measures a count rate less than

50 cps.

Monitoring Function Automatic infusion operations will not start if

operation shield-open error is detected. Automatic

infusion operations are terminated (if in progress)

for all of the preceding conditions.

Purge-generator-to-waste and purge-generator-to-

patient operations will not start and will be

terminated if in progress if a high-pressure error,

valve error, pump limit, or shield-open error is

detected.

Syringe Pump Capacity Mechanically limited to ~130mL full capacity.


RS-232C Port Characteristics

Description:

The RS-232C port echoes out infusion report

printout data for access by a remote computer.

Although this port has a receive line, the

CardioGen-82 Infusion System does not recognize

incoming data.

RS-232C Port Interface Details:

The recommended RS-232 interface cable to be

attached to the CardioGen-82 Infusion System

should be a shielded type cable less than or equal to

100 feet long. If an RS-232 cable is attached to the

CardioGen-82 Infusion System that exceeds the 100

foot length, the system should be observed to verify

normal operation as well as other electronic

equipment in the vicinity of the CardioGen-82

Infusion System. If abnormal operation is

observed, it may be necessary to re-orient the

RS-232 cable to the CardioGen-82 Infusion System.

Signal DB25P Connector Pin

TX (transmit data) (pin 2)

RX (receive data) (pin 3)

This signal is not used.

GND (signal ground) (pin 7)

Data Format Baud Rate

1 Start bit

1 Stop bit

8 Data bits

No Parity

2400 bit/sec


System Power Requirements

System power is 2.5A max. This system can be set

for 100/120/220/240V~ operation via the power

entry module. To change this setting, ensure that the

system is unplugged from its power source, and use

a small flat screwdriver to remove the fuse drawer

of the power entry module. Remove the small

voltage selector card and rotate the card until the

desired voltage is shown. Then replace the card and

fuse drawer. Use only the fuse type and rating as

indicated on the system label located near the power

entry module.

System Weight: 650 lbs.

System Size: See Fig. 2.1

Shipping Weight: 875 lbs.

Shipping Size: 48"H x 31"W x 41"L

Life Time of Device 10 years, provided all maintenance and service is

performed as required.

Environmental Conditions For

Operation, Transporting And

Storage of System

The system should be operated in a normal office

environment, but can be safely operated, stored, and

transported between temperatures of 40°F (4.4°C) -

110°F (43.3°C). This is primarily due to

characteristics of the detector. Although no known

problems have been encountered with storage and

transport of the system below or above these

temperatures, it would be best not to subject it to

extreme high or low temperatures beyond this point

for an extended period. Avoid condensing humidity

conditions.


4. SYSTEM OPERATION

4.1 Introduction

This section of the CardioGen-82 Infusion System manual describes the

display/control panel features and operating modes of the infusion system. The user,

however, must refer to the specific operating procedures contained in Section 5 of

this manual for the CardioGen-82 Generator when performing system preparations,

calibrations, breakthrough strontium-82/strontium-85 measurements, and infusions.

4.2 The Display/Control Panel

All displays and controls for the CardioGen-82 Infusion System, except for the

CALIBRATION FACTOR switch, are located on the Display/Control Panel which is

illustrated in Figure 4.1. This Figure should be referred to during the following

discussion of the Display/Control Panel features.

4.2.1 POWER ON/OFF Switch

This momentary-contact, push-button-indicator switch is used to apply power and

turn off the infusion system. When the system is powered, this switch glows green.

If AC power to the infusion system is interrupted, it is necessary to depress this

switch to repower the system. When the system is turned off by the E-STOP /

ABORT switch, the system can only be turned back on by rotating the E-

STOP/ABORT switch clock-wise, until the E-STOP/ABORT switch “resets” by

popping up. If this E-STOP/ABORT switch is not “reset,” the Start switch is

rendered disabled.

4.2.2 EMERGENCY STOP/ABORT Switch

If the Infusion System Model has a red E-STOP /ABORT Switch: Please note that

this switch does not turn off AC power to the system, and as long as the system’s

power cord is plugged into a live AC electrical outlet, there will be AC power to the

system as indicated by the lighted AC Main LED indicator on the Display Control

Panel. This switch works as an emergency cutoff to stop the system in case of

emergencies. In order to turn the system back on, the switch must be rotated clock-

wise, until the switch “resets” by popping up. If this E-STOP/ABORT switch is not

“reset” the Start switch is rendered disabled.

If the Infusion System Model has a momentary-contact, push-button-indicator Power

Off/Abort Switch: Depressing this switch turns off the system.


4.2.3 MODE Switch

This rotary switch is used to select the operating mode of the infusion system. The

modes available are:

AUTOMATIC INFUSION,

PURGE-GENERATOR-TO-WASTE, and

PURGE-GENERATOR-TO-PATIENT.

4.2.4 MODE Display

The mode display is an illuminated flow diagram showing the routing of saline in the

infusion system. The mode display shows the saline flow path for all operating

modes of the infusion system.


Figure 4.1 Image of the Display/Control Panel


4.2.5 INJECT START/STOP Switch

This momentary-contact, indicator-push-button switch is used to start an automatic

infusion. This switch illuminates during an infusion and is extinguished once the

infusion pumping operation is complete. This switch may be depressed during an

infusion to stop the infusion.

4.2.6 PURGE Switch

This momentary-contact, push-button switch is used to purge the infusion system in

the PURGE-GENERATOR-TO-WASTE or PURGE-GENERATOR-TO-PATIENT

mode. It is necessary to continuously depress this switch during a purge operation.

4.2.7 REFILL Switch

This momentary-contact, push-button switch is used to refill the saline pump. To

start a refill operation, depress the REFILL switch once. The pump will begin

refilling and will stop when either the pump limit is reached or the operator depresses

the REFILL switch a second time.

4.2.8 FLOW RATE Switch

This rotary switch is used to select the saline-pump flow rate used during infusion

and purge operations. The available flow rates are:

20 mL/min

35 mL/min

50 mL/min (50 mL/min must be used for the CardioGen-82 Generator) 65 mL/min

80 mL/min

4.2.9 ELUTION VOLUME Display and Limit Switch

This display and limit switch combination is used to display the total generator

elution volume during an infusion operation and to set the elution volume limit for

the infusion. Note that the ELUTION VOLUME display provides a running display

of generator elution volume during an infusion and holds the total elution volume

after the infusion operation is completed. Both the ELUTION VOLUME display and

limit switch operate over the range of 0-99 mL.


4.2.10 PATIENT VOLUME Display and Limit Switch

This display and limit switch combination is used to display the patient elution

volume during an infusion operation and to set the patient volume limit for the

infusion. Note that the PATIENT VOLUME display provides a running display

of patient elution volume during an infusion and holds the total patient elution

volume after the infusion operation is completed. Both the PATIENT VOLUME

display and limit switch operate over the range of 0-99 mL.

4.2.11 PATIENT DOSE Display and Limit Switch

This display and limit switch is used to display the patient dose (mCi) during an

infusion operation and to set the patient dose limit for the infusion. Note that the

PATIENT DOSE display provides a running display of patient dose during an

infusion and holds the total patient dose after the infusion operation is completed.

Both the PATIENT DOSE display and limit switch operate over the range of 0-99

mCi.

4.2.12 DOSE RATE Display and Threshold Switch

This display and threshold switch combination is used to display the infusion

system dose rate (mCi) during an infusion operation and to set the dose rate

threshold for the infusion. Both the DOSE RATE display and threshold switch

operate over the range of 0.0-9.9 mCi/sec, where mCi/sec represents the amount

of activity produced by the infusion system in a one-second time interval. For

Rb-82 the proper setting is 1.0 mCi/sec.

4.2.13 PUMP LIMIT Indicator Light

This light glows yellow whenever the saline pump is at either the refill limit

(pump fully extended) or at the pump limit (pump fully contracted). No infusion

or purge operation can be started with the pump at the fully contracted pump limit

position. Additionally, if the pump reaches the fully contracted pump limit

position during an infusion or purge operation, that operation will be terminated

automatically.

4.2.14 HIGH PRESSURE Indicator Light

This light glows red whenever the generator inlet pressure exceeds the preset

high-pressure threshold. Infusion and purge operations cannot be started if there

is a high-pressure error. Additionally, if a high-pressure error occurs during an

infusion or purge operation, that operation will be terminated automatically.


4.2.15 VALVE FAILURE Indicator Light

This light glows red whenever the system has detected a valve error. The system

detects valve positioning errors by measuring the time required for the valve to

move from one position to the next position. Additionally, the system

continuously tests the valve to ensure that it is in the correct position. Infusion

and purge operations cannot be started if there is a valve error. Additionally, if a

valve error occurs during an infusion or purge operation, that operation will be

terminated automatically.

4.2.16 AC MAIN Indicator Light

If equipped, this light glows green as long as the system’s power cord is plugged

into a live AC electrical outlet. This light indicates there is live AC power inside

the system, even though the system is not “powered on.”

4.3 The CALIBRATION FACTOR Switch

The CALIBRATION FACTOR switch contains a four-digit number which

controls the calibration of Rb-82 delivery. This switch is adjusted only during

calibration and is located away from the Display/Control panel to prevent

accidental changing of its setting. The CALIBRATION FACTOR switch is

located on the processing-electronics chassis front panel.

The CALIBRATION FACTOR switch is set by depressing the small buttons

associated with each digit using a pointed object such as a writing pen.

4.4 System Activation

Depressing the POWER ON/OFF switch activates the infusion system and causes

this switch to glow green indicating that the infusion system is powered. Note that

the POWER ON/OFF switch is used in a power latching-relay system to prevent the

infusion system from restarting following an AC power failure. If AC power to the

infusion system is interrupted, or if the E-STOP/ABORT switch is depressed, it is

necessary to depress the POWER ON/OFF switch again to reactivate the infusion

system.

Depressing the POWER ON/OFF switch shuts the infusion system off. This switch

allows the operator to easily shut the system off during normal shutdown. In the

event a problem is experienced, the E-STOP/ABORT switch must be depressed to

shut down the system.


4.5 Pump Refill Operation

The saline pump must be filled with saline (0.9% additive-free sodium chloride

injection, USP) solution before the CardioGen-82 Infusion System can be purged of

air or before an infusion can be performed. In order to refill the saline pump, the

REFILL switch is depressed once and the pump will begin refilling. The refill

operation can be stopped by the operator by depressing the REFILL switch a second

time or by letting the pump reach its refill limit. It is, of course, important to ensure

that the saline supply valve is open to permit the pump to accept saline from the

saline supply.

4.6 Purge Modes

The CardioGen-82 Infusion System must be purged of air before an infusion can be

performed. There are two purge modes used for purging the system: PURGE-

GENERATOR-TO-WASTE, and PURGE-GENERATOR-TO-PATIENT. In the

PURGE-GENERATOR-TO-WASTE mode, saline (0.9% additive-free sodium

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.


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


4.7 Automatic Infusion Mode

SUMMARY OF THE AUTOMATIC INFUSION OPERATION

Figure 4.3 a Activity Build Up Cycle


Figure 4.3 b Patient Infusion Cycle


Figure 4.3 c Infusion Ending Cycle

Date of Issue: February - 2015 of 88 Page 43 of 88

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.


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


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.


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

sequence.

5.4 Installation of the Syringe Pump Components

5.4.1 Pump Syringe Installation (Pump Syringe Pkg. #1)

Loosen the 4 thumb screws, upper and lower, on the pump syringe carriage. Install

the 140 mL pump syringe with its luer lock fitting facing upward into its carriage in

the pump assembly. Be sure to rotate the syringe so that the graduations face toward

the operator. Tighten the upper and lower thumbscrews to secure both the syringe

body and plunger into the carriage. Do not remove the protective cap on this syringe

until directed to do so.

5.4.2 Pressure Sensor Syringe Installation (Inlet Assembly Pkg. #2)

Install the 10 mL pressure sensor syringe by placing it with the luer lock fitting facing

upward into the carriage in the pump assembly. This is done by tilting the syringe

into place with the plunger contacting the bottom of the carriage followed by pushing

the top of the syringe back until it's locked in place. Be sure to rotate the syringe so

the graduations face toward the operator. Do not remove the protective cap on this

syringe until directed to do so.


5.4.3 Pump Cover Installation

Re-install the pump cover by carefully sliding it over the top of the pump assembly

with the pump syringe and pressure sensor syringe protruding through the pump

cover. Be sure the protective caps on the syringes protect the syringe luer lock fittings

from contacting the pump cover. Verify that the pump cover is fully seated on the

pump assembly.

5.5 CardioGen-82 Generator Inlet Assembly Package

Remove protective cap from 140 mL pump syringe. Remove the tubing assembly

from its package and connect the check valve to the pump syringe. Tighten the luer

lock fittings, but be careful not to damage the pump syringe connection.

5.5.1 Pressure Sensor Line Installation

Remove protective cap from 10 mL pressure sensor syringe. Connect the shortest line

of the inlet tubing assembly to the 10 mL sensor syringe. Tighten the syringe to the

luer lock connection, but be careful not to damage.

5.5.2 Generator Inlet Line Installation

Open the valve shield. Take the longest line of the generator inlet tubing assembly

and insert it down through the tubing shield so that it appears in the generator shield.

Remove the generator shield lead lid and retrieve the free end of the generator inlet

line. Approximately three to six inches of this line will now be in the generator shield

with the luer lock fitting and the cap on. Place the saline supply hook assembly back

onto the pump assembly.

5.5.3 Generator Inlet Line Sterilizing Filter Installation

The Generator Inlet line filter and Valve Assembly is approximately 11 inches long

and has a female luer lock at the proximal end and a purple check valve with a male

luer lock and a blue cap at the distal end. Take the inlet filter and valve assembly

from the generator inlet assembly package 2, remove the protective caps and connect

the female luer lock fitting of the Generator Inlet Filter and Valve Assembly tubing

to the male luer lock fitting on the free end of the generator inlet line that is now

located in the generator shield. Make sure that the luer lock fitting with the blue cap

on the other end of this filter remains in place until directed to do otherwise.


5.6 CardioGen-82 Generator Outlet Assembly (Pkg. #3)

5.6.1 Divergence Valve Installation

If it is not already open, raise the lid on the valve shield assembly located on the top

of the CardioGen-82 Infusion System and remove the valve retainer. Note: The lid

cannot be raised if the CardioGen-82 Infusion System is unpowered or if the system

detects activity within this shield. Take the divergence valve, (the white valve with

the three arrows and the off sign) and orient it with the handle facing down toward

the bottom of the CardioGen-82 Infusion System. Note: The shortest line of this

connection will be facing towards the left end of the infusion system as you are

looking at it. Finally, without changing the orientation of the valve, rotate the valve

handle so that the valve can be dropped into its actuation carriage, to prevent it from

being moved, with the "valve" arm fitting into the groove of the actuation carriage.

5.6.2 Generator Outlet Line Installation

Take the line with the red cap end and feed it through the hole in the valve shield

assembly. Verify that the end of this line has entered the generator shield. There

should now be two lines in the generator shield; the generator inlet line with its

associated filter and the generator outlet line. Secure the end of the generator outlet

line (located in the valve shield assembly) by inserting into the tubing slot near the

detector and route the line past the detector secure with detector cover.

5.6.3 Generator Waste Line Installation

Take the line from the outlet tubing assembly with the clear end and feed it down

the opening of the valve shield assembly. There should now be three sets of tubing

in the generator shield.

5.6.4 Generator Waste Line To Waste Shield

Take the line in the generator shield with the clear cap and feed it through the hole

inside the generator shield into the waste shield. Tape the tubing in the generator

shield so that the generator will not crimp the tubing.


5.6.5 Waste Bottle Preparation and Sterilizing Filter Installation

The Waste Line Filter set is approximately 15 inches long and has a female luer lock

at the proximal end and a male luer lock with a clear cap at the distal end. From the

outlet assembly package take the short line with the filter in the middle, remove the

protective caps and connect the female luer lock fitting of the Waste Line Filter

tubing to the male luer lock fitting on the free end of the generator waste line that is

now located in the waste shield. Once this connection has been made, take the waste

bottle and connect the waste line to the top of the waste bottle cap. Make sure you

remove the cover from the needle under the bottle cap cover. Verify that the waste

bottle connections are correct. Take the waste filter and hold it flat against the waste

bottle about half way down the waste bottle and carefully lower the waste bottle into

the waste shield. Make sure no tubing is under the waste bottle as you place it back

in the waste shield and route the extra waste line tubing to prevent any kinking or

obstruction in the tubing. Place the lid on top of the waste shield.

Bracco Diagnostics recommends that a new waste bottle cap be installed with each

new generator installation. The waste bottle should be emptied every morning

prior to system use.

5.6.5.1 Removing Waste Bottle from Waste Shield

The Waste Bottle should be emptied every morning prior to system use.

1. Precautions:

a. The CardioGen-82 generator eluate is radioactive and should be

handled with proper radiation safety precautions.

b. Wait at least 10 minutes after any purge or infusion operation

before lifting the waste bottle shield cover. This will allow any

Rb-82 eluate to decay to a safe level.

c. Always wear gloves before touching any of the tubing, syringe

pump, valve, or collection bottle system components.

2. All components that may contain residual radioactivity must be stored and

disposed of in accordance with the facility’s radioactive materials license.

3. Preparations: Place an absorbent pad on the top of the generator well lid. Be

sure you have prepared the saline disposal location prior to removing the

waste bottle from the system. It is recommended that you use absorbent

pads (see absorbent Pad Kit, sku 001575) designed for placement at the

bottom of the waste bottle well.

4. Open system cabinet door and lift off waste shield lid. Place lid on the

infusion system counter top.

5. Grasp the waste bottle cap and pull the bottle straight out of the waste

shield. DO NOT USE THE WASTE BOTTLE TUBING TO PULL THE

WASTE BOTTLE OUT OF THE WASTE BOTTLE WELL.


6. Unscrew the cap from the bottle and tap gently over the opening of the

waste bottle to dislodge any drops of waste solution from cap spike back

into the waste bottle. Place the cap on the absorbent pad on top of the

generator well lid.

5.6.5.2 Emptying Waste Bottle

1. Empty the waste bottle into the appropriate receptacle and dispose of in

accordance with the facility’s radioactive materials license.

2. Inspect the waste bottle and waste bottle cap for obvious signs of wear or

any cracks or holes.

3. If the bottle is acceptable, screw the cap back on the bottle. If not, take a

new bottle and a new cap from your inventory.

4. Note: If you use a new cap, make sure you remove the cover from the needle

under the bottle cap cover.

5.6.5.3 Reinstalling Waste Bottle

1. Take the waste filter and hold it flat against the waste bottle about half way

down the waste bottle.

2. Make sure no tubing is under the waste bottle as you place it back in the

waste shield.

3. Carefully place the waste bottle and waste line filter back into the waste

shield. They should slide easily back into the waste shield. If they don’t fit

all the way to the bottom easily, remove and inspect the tubing position.

4. Do not force the waste bottle or waste line filter into position. Doing so may

break or kink part of the system.

5. Pick up waste shield lid and place it on the waste shield making sure no

tubing is caught in between it and the waste shield.

6. Collect the absorbent pad from the top of the generator well lid and dispose

of in accordance with the facility’s radioactive materials license.


5.7 Patient Administration Set Installation

Remove a patient administration set from its protective wrapping. Connect the

female side of the luer lock fitting to the line on top of the infusion cart system which

comes out the left side of the valve. This patient administration set contains its own

sterilizing filter. This is the only part of the system that you must change as a new

patient is being imaged. Make sure that the valve retainer is now over the valve and

close the lid.

5.8 Saline Supply Installation

0.9% additive-free sodium chloride injection, USP

Take the remaining free tubing of the generator inlet line, which was the first kit you

hooked up, pinch off valve and then carefully insert the spike into your bottle or bag

of preservative-free, normal saline (0.9% additive-free sodium chloride injection,

USP). Make sure the spike is fully inserted. Hang the saline supply on the saline

supply hook located on top of the pump assembly.

5.9 CardioGen-82 Generator Installation

5.9.1.Installation Preparation

Look inside the generator shield and verify that there are two lines available for

connection:

Generator inlet line and its attached filter with a male luer lock fitting.

Generator outlet line with a female luer lock fitting

Make sure the waste line that passes through the generator shield chamber is against

the wall of the generator shield so that it does not interfere with the generator

installation.

5.9.2.CardioGen-82 Generator Installation

Remove the generator from its shipping container and untie the outlet and inlet

tubing. Carefully lower it into the generator shield. Make sure that the generator does

not interfere with the waste line that passes through the generator shield. Remove the

protective caps (generator pigtail line cap is white, and inlet filter and valve cap is

blue) and connect the inlet line on the generator (marked "inlet," and has a female

luer lock fitting on it) to the remaining fitting on the Generator Inlet line filter and

Valve Assembly which has a male luer lock fitting on it.

Remove the protective caps (generator pigtail line cap is white and outlet line cap is

red) and connect the outlet line of the generator (marked outlet and has a male luer

lock fitting on it) to the remaining line in the generator shield which has a female luer

lock fitting on it. Carefully lower the generator shield lid making sure that none of

the lines are restricted.


5.10 Purge Operation

5.10.1 Syringe Filling

Position the syringe pump to its limit, if not already there, by continuously

depressing the PURGE switch (in the PURGE GENERATOR TO WASTE mode)

until the pump automatically stops. Open the saline supply pinch valve and

depress the REFILL switch once. The syringe pump should begin drawing in

saline (0.9% additive-free sodium chloride injection, USP) and a stream of air

bubbles should appear in the saline supply bottle. The refill operation can be

stopped at any time by depressing the REFILL switch a second time. Otherwise,

the pump will continue refilling until it reaches its refill limit and automatically

stops. Unless problems are encountered, allow the pump to refill until it

automatically stops on its refill limit.

5.10.2 Waste Line Purging

With the MODE switch in the PURGE GENERATOR TO WASTE position

continually depress the PURGE switch to pump saline (0.9% additive-free sodium

chloride injection, USP) through the generator and into the waste bottle. A volume

of 50 mL of saline (0.9% additive-free sodium chloride injection, USP) should be

sufficient to guarantee purging the waste lines of air. Note: The purge volume can

be checked by observing the markings on the pump syringe. Lift the waste bottle

shield cover and look for any signs of leakage. Correct any leaking connections

before continuing to use the CardioGen-82 infusion system.

Note: It is recommended that leak testing be carried out by wipe test and radiation

detection survey.

5.10.3 Pressure Sensor Line

Pinch off the saline bag valve, disconnect the pressure sensor line from the pressure

sensor syringe, and place it in a container. Depress the purge switch until liquid

flows into the beaker. Reconnect the pressure sensor line to the pressure sensor

syringe. Now unpinch the saline valve.

5.10.4 Patient Administration Set Purging

Place the MODE switch in the PURGE GENERATOR TO PATIENT position.

Connect the patient administration set to a shielded 50 mL vial and insert a venting

needle. Continuously depress the PURGE switch until all the air has been expelled

from the patient administration set into the vial. A volume of 20 mL should be

sufficient to purge the patient line. The purge volume can be determined by

observing the pump syringe markings.

Lift the generator shield cover and look for any signs of leakage. Correct any

leaking connections before continuing to use the CardioGen-82 Infusion System.


Note: It is recommended that leak testing be carried out by wipe test and radiation

detection survey.

5.10.5 Volumetric Flow Rate Verification

This is performed with the installation of a new generator.

Set the controls on the Display/Control Panel as follows:

• Mode Switch = Automatic Infusion

• Elution Volume Limit = 99 mL

• Patient Volume Limit = 50 mL

• Patient Dose Limit = 99 mCi

• Dose Rate Threshold = 1.0 mCi/sec.

• Flow Rate = 50 mL/min.

Check for a 50 mL/min. flow rate using a stop watch.

5.11 Patient Administration

PATIENT ADMINISTRATION MAY BE PERFORMED ONLY AFTER

SUCCESSFUL COMPLETION OF DAILY QUALITY CONTROL

PROCEDURES ( COLUMN WASH, SR-82/85 TESTING, AND

CALIBRATION).

THE INFUSION SYSTEM’S DAILY CALIBRATION MUST BE

PERFORMED USING THE SAME DOSE/ACTIVITY (mCi Rb-82) THAT

WILL BE USED FOR A PATIENT ADMINISTRATION DOSE..

IN THE EVENT OF A POWER-FAILURE OR THE SYSTEM IS

INADVERTENTLY SHUT DOWN, CALIBRATION SHOULD BE

RECONFIRMED.

5.11.1. Replace the patient administration set for each new patient.

5.11.2. Purge all air out of the patient administration set and verify that all air is purged

from the system. Refer to Installation Instructions, section 5.

5.11.3. Set the controls on the Display/Control panel as prescribed by the administering

physician.

Note: Patient dose must be at the same level of activity (mCi Rb-82) as was

used in the most recent calibration. If the level of activity of the patient dose

is different than the level of activity used for calibration, calibration must be

performed again at the new activity level.


5.11.4. Verify that the syringe pump has been filled with saline (0.9% additive-free

sodium chloride injection, USP). The syringe pump volume must at least equal the

selected elution volume-set point plus 20 mL. This volume will cover the 15 mL

nominal dead volume in the syringe.

5.11.5. Verify that the system printer is on and that approximately 1 inch of paper extends

out of the printer. If the RS-232C port is being used for infusion data acquisition,

the system printer can be turned off. Infusion report data is transmitted out the

RS-232C port whether the system printer is powered or not.

5.11.6. Attach the CardioGen-82 Infusion System patient administration set to the

patient’s intravenous line.

5.11.7. Make sure that at least 10 minutes has elapsed following any purge or infusion

operation. Start the infusion by depressing the INJECT START/STOP switch.

NOTE: The infusion can be terminated at any time by depressing the INJECT

START/STOP switch a second time.

The running elution volume (mL), patient volume (mL), patient dose (mCi), and

dose rate (mCi/sec) will be registered on the control/display panel. Once the

infusion operation is completed the INJECT START/STOP switch will stop

glowing red and the infusion report data will be printed on the system printer and

echoed out the RS-232C port.

5.11.8. Unless manually interrupted, the infusion will terminate when either a) the patient

dose limit (mCi), b) the patient volume limit (mL), or c) the total elution volume

limit (mL) has been reached, whichever comes first.

5.11.9. If the infusion system repetitively terminates patient infusions based on the

reaching of patient or elution volume limits, particularly if the upper limit of 99

mL is being reached, then the user should verify that the generator has not reached

Expiration Limits.

NOTE: THE CardioGen-82 GENERATOR ELUATE IS RADIOACTIVE

AND SHOULD BE HANDLED WITH PROPER RADIATION

SAFETY PRECAUTIONS.

NOTE: WAIT AT LEAST 10 MINUTES AFTER ANY PURGE OR

INFUSION OPERATION BEFORE LIFTING THE GENERATOR

SHIELD COVER, WASTE BOTTLE SHIELD COVER, OR THE

VALVE-SHIELD COVER. THIS WILL ALLOW ANY RB-82

ELUATE TO DECAY TO A SAFE LEVEL.

NOTE: THE VALVE-SHIELD COVER AUTOMATICALLY LOCKS IN

THE CLOSED POSITION DURING ANY PURGE OR INFUSION

OPERATION. THE COVER REMAINS LOCKED UNTIL THE

DETECTED RADIOACTIVITY DECAYS TO A SAFE LEVEL. NO

PURGE OR INFUSION OPERATION CAN BE STARTED UNLESS

THE COVER IS CLOSED. ADDITIONALLY, THE COVER


CANNOT BE RAISED UNLESS THE CARDIOGEN-82 INFUSION

SYSTEM IS POWERED.

NOTE: ALWAYS WEAR GLOVES BEFORE TOUCHING ANY OF THE

TUBING, SYRINGE PUMP, VALVE, OR COLLECTION BOTTLE

SYSTEM COMPONENTS.


Figure 5.1 Tubing Diagram


CardioGen-82 (Rubidium 82) Generator - Sr-82/85 Testing Instructional Worksheet

Use an ionization chamber-type dose calibrator for eluate testing.

Daily, before administering rubidium Rb 82 chloride injection to any patient,

perform an eluate testing to determine Rb-82, Sr-82, and Sr-85 levels

Perform additional daily eluate tests after detecting any of the following Alert

Limits:

o 14 L total elution volume has passed through the generator column, or

o Sr-82 level reaches 0.002 µCi per mCi Rb-82, or

o Sr-85 level reaches 0.02 µCi per mCi Rb-82.

Perform the additional daily eluate tests at time points determined by the day’s

elution volume; tests are performed every 750 mL.

o For example, if an Alert Limit were reached and the clinical site eluted less than

750 mL from the generator during the day, then no additional eluate tests would

have been performed that day.

o If the same clinical site the next day eluted 1,500 mL from the generator, then the

site would have performed three tests that day: 1) the required daily test that

precedes any patient dosing, 2) a test at the 750 mL elution point, and 3) a test at

the 1,500 mL elution point.

o If a generator’s Alert Limit is reached, the clinical site performs the additional

daily tests (at intervals of 750 mL) each subsequent day the generator is used. The

additional tests are necessary to promptly detect excessive Sr-82 and/or Sr-85 in

eluates.

Date _________________

Infusion System Control Panel Settings

Mode Switch: Automatic Infusion

Elution Volume: 99 mL

Patient Volume: 50 mL

Patient Dose: 99 mCi

Dose Rate: 1 mCi/sec.

Flow Rate: 50 mL/min.

Dose Calibrator Setting

504 (Capintec only) or

Co-60 setting then divide reading obtained by 0.548

_______________________________________________________


1. Elute the generator with 50 mL of Sodium Chloride Injection USP at a rate of 50

mL/min and collect the eluate in a 50 mL stoppered glass vial using the Infusion

System Control Panel Settings as above. Note the exact time at end of elution (EOE).

Time at end of elution (EOE)____________________________________.

2. Set dose calibrator as above. Setting used: ________________________.

3. Measure Rb-82 activity in the dose calibrator. Note the exact time (minutes/seconds)

when the measurement is made.

Rb-82 activity ________________________________________(mCi).

Time of measurement ______________________________________.

4. To account for radioactive decay, correct the Rb-82 measurement back to the EOE

using the appropriate decay correction factor (called “fraction remaining” in the

table) obtained from Table 1 below:

TABLE 1

Physical Decay Chart: Rb-82 half-life 75 seconds

Seconds* Fraction

Remaining

Seconds* Fraction

Remaining

0 1.000 165 0.218

15 0.871 180 0.190

30 0.758 195 0.165

45 0.660 210 0.144

60 0.574 225 0.125

75 0.500 240 0.109

90 0.435 255 0.095

105 0.379 270 0.083

120 0.330 285 0.072

135 0.287 300 0.063

150 0.250

To calculate the Rb-82 activity at EOE, divide the measurement of Rb-82 activity by

the decay correction factor corresponding to the time delay (in seconds) between

EOE and measurement, as found in Table 1 above.

Decay correction factor_________________________________

Rb-82 activity at EOE (mCi)_____________________________

5. Using the same vial, allow the sample to stand for at least one hour to allow for the

complete decay of Rb-82.

6. Measure the residual activity of the sample in the dose calibrator. Set the instrument

to read in microcuries (μCi) and record the measurement.

Residual activity (μCi)_________________________________


7. Calculate the ratio (R) of Sr-85/Sr-82 on the day (post-calibration) of measurement

using the ratio of Sr-85/Sr-82 on the day of calibration provided on the generator

label and the Sr-85/Sr-82 Ratio Factor from Table 2 below.

TABLE 2

Sr-85/Sr-82 Ratio Chart

Days Ratio Factor Days Ratio Factor Days Ratio Factor

0* 1.00 16 1.31 32 1.73

1 1.02 17 1.34 33 1.76

2 1.03 18 1.36 34 1.79

3 1.05 19 1.38 35 1.82

4 1.07 20 1.41 36 1.85

5 1.09 21 1.43 37 1.88

6 1.11 22 1.46 38 1.91

7 1.13 23 1.48 39 1.95

8 1.15 24 1.51 40 1.98

9 1.17 25 1.53 41 2.01

10 1.19 26 1.56 42 2.05

11 1.21 27 1.58

12 1.23 28 1.61

13 1.25 29 1.64

14 1.27 30 1.67

15 1.29 31 1.70

*Day of calibration

Determine R using the following equation:

[Sr-85]

R = ———— on calibration date X Ratio Factor on the day

[Sr-82] (post-calibration) of measurement

8. Use a correction factor (F) of 0.478 to compensate for the contribution of Sr-85 to

the reading.

9. Calculate the amount of Sr-82 in the sample using the following equation:

dose calibrator reading (μCi)

Sr-82 (μCi) = —————————————

[1 + (R) (F)]

Example: dose calibrator reading (μCi) = 0.8; Sr85/Sr82 ratio (R) =1.48; correction

factor (F) = 0.478.


0.8

Sr-82 (μCi) = ———————— = 0.47

[1 + (1.48)(0.478)]

Alternatively, calculate the amount of Sr-82 in the sample using the divisor provided

by the manufacturer, as per the following equation:

Sr-82 (μCi) = ______dose calibrator reading (µCi)______

divisor (from sheet supplied with Generator)

Example: dose calibrator reading (μCi) = 0.8; divisor = 1.7

Sr-82 (μCi) = ___0.8___ = 0.47

1.7

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.


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 ______________ .


Figure 5.2 SR-82 / SR-85 Testing Worksheet


Figure 5.3 Rb-82 Infusion System Calibration Log Sheet


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.


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


CardioGen-82 Infusion System Diagram


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"


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"


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


Elution Volume Print Out


Patient Volume Print Out


Patient Dose Print Out


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.


gggg

Pump Limit Print Out


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


Thumbwheel Error Print Out


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


Valve Failure Control Panel


Valve Failure Print Out


Valve Shield Open

NOTE: This error is activated even if valve shield is slightly open and not depressing the red switch button.


Valve Shield Open Print Out


High Pressure Errors

Error Condition



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


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.


82-83

High Pressure

Faulty tubing, filter, or other

accessory pack or PAS component


Replace accessories as deemed necessary. The CAS or Field Service Engineer will decide if

customer should bypass the generator


82-83

High Pressure

Vent needle not fully pierced

through the elution test vial

septum during testing


Make sure proper positioning of vent needle and the patient administration set (PAS) needles are

inserted fully into elution test vial septum


82-83

High Pressure

Waste bottle cap filter failure or

clogging


Replace waste bottle cap NOTE: New waste bottle cap should be installed

with each new generator


82-83

High Pressure

Improper flow rate setting

(80ml/min instead of 50ml/min)


Flow rate setting should always be set to 50ml/min in accordance with Prescribing

Information (PI)


82-83

High Pressure

Generator column failure/blockage


Run through all other troubleshooting potential causes before bypassing generator. NOTE:

Customers must contact CAS prior to bypassing the generator.


82-83


High Pressure Control Panel


High Pressure Print Out


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



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


Issues System Leak


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


Issues

Timing inconsistency in

dose assay


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).


Issues

Incorrect channel selected on dose calibrator when assaying Rb-82

eluate for CardioGen-82 QC


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


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


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


Issues Equipment power surge



Equipment power surge can effect dose accuracy of dose calibrator and infusion system

Notify CAS.


Issues

High background in hot lab when assaying Rb-82 elution vials for QC



Reduce background to a minimum. Always make sure

background is subtracted when performing level testing


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



After observing differences between the Infusion System Print-out Set Point Values and actual Control Panel Setting

values, notify CAS.


Issues

A site unknowingly tries to be within +/- 5% threshold for daily calibration, instead of the +/- 10% threshold



Instruct the user that they only have to achieve +/- 5%

threshold on day one and +/-10% thereafter


Thumb Screws


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

Services

1-800-257-5181

Option 2

8. CARDIOGEN-82® Infusion System Supplies

Catalog #

Description: CARDIOGEN-82®

0270-0015-00

CARDIOGEN-82® (Rubidium Rb 82 Generator)

001575

Absorbent Pad

001510

Accessory Package

001536

Elution System

001530

Elution Test Vial

001550

Elution Vial Shield

001537

Infusion System

001565

Infusion System Thermo Paper (Case of 12)

001506

Patient Administration Sets (25 sets)

001511

Vented Cap for Waste Bottle

001520

Waste Bottle

ECN 14-1212-1 Rev. 23

CardioGen-82 (Rubidium Rb 82 Generator) INFUSION SYSTEM ... · date of issue: february - 2015 page...

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