Important Safety Information
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The RUBY-FILL 3,7 GBq Radionuclide Generator contains an accelerator produced Strontium-82, which decays to Rubidium-82. When the generator is eluted with saline it produces a sterile, non-pyrogenic solution of Rb-82 Chloride.
Due to the short half-life (75 s) of Rb-82, the use of an elution system is required for delivery of the Rb-82 Chloride into a patient for the purposes of performing Myocardial Perfusion Imaging with PET. PET imaging with Rb-82 Chloride may be performed under rest and/or stress conditions.
The Rubidium Elution System has been exclusively designed to be used with the RUBY-FILL 3,7 GBq Radionuclide Generator and to deliver accurate doses of Rb-82 Chloride to patients.
Intended Use:
The RUBY Rubidium Elution System is specifically designed for use with the RUBY-FILL 3,7 GBq Radionuclide Generator. The RUBY Rubidium Elution System is intended to accurately measure and automatically deliver doses of the radiodiagnostic agent 82RbCl (Rubidium Chloride Rb 82 Injection) for use in cardiac positron emission tomography (PET) imaging.
The RUBY Rubidium Elution System should only be used by physicians and technologists with adequate training and experience in the safe use and handling of radionuclides, and with appropriate certifications from regional or national agencies.
RUBY Tubings:
- The RUBY Saline Line is a tubing set that connects the saline supply from the saline bad through the RbES peristaltic pump to the RUBY SET.
- The RUBY SET is a tubing set which directs fluid from the RUBY Saline Line, through the RUBY-FILL 3,7 GBq Radionuclide Generator (or by-pass) and out to either the RUBY IV Line or RbES waste container.
- The RUBY IV Line is a tubing set to administer 82Rbcl injection eluted from the RUBY-FILL 3,7 GBq Radionuclide Generator to the patient.
Indication for Use:
The RUBY Rubidium Elution System is designed to be used only with RUBY-FILL 3,7 GBq Radionuclide Generator for the cardiac PET imaging of adults. Please refer to RUBY-FILL 3,7 GBq Radionuclide Generator labeling for the further information on the indications and dosage recommendations.
Indication and Important Safety Information
This medicinal product is for diagnostic imaging use only. Rubidium (82 RbCl) chloride injection is used with positron emission tomography (PET) for the assessment of myocardial perfusion and is indicated for the detection and localization of coronary artery disease in adult patients with known or suspected coronary artery disease.
Contraindications: Hypersensitivity to the active substance or any excipients; use of eluate in which specified strontium (Sr 82/Sr 85) limits are exceeded; use with solutions other than additive free 0.9% sodium chloride for injection.
The risk information provided here is not comprehensive.
Performance Specifications
- Accurate automated measurement and delivery of Rb-82 doses for myocardial PET imaging.
- Dose delivery accuracy within ±10% of the requested dose.
- Real-time activity monitoring using an integrated radioactivity counter.
- Automated Sr-82/Sr-85 breakthrough determination using an integrated dose calibrator.
- Controlled saline delivery through a peristaltic pump operating at 6-30 mL/min.
- Supports Constant Activity, Constant Flow, and Constant Time infusion modes.
- Automated calibration, quality control, flushing, and infusion management.
- Software-controlled safety checks, alarms, interlocks, and continuous system monitoring.
Excess radiation exposure with failure to follow quality control testing procedure
Excess radiation exposure occurs when the 82Sr and 85Sr levels in rubidium (82Rb) chloride injection exceed the specified generator eluate limits. To minimize the risk of unintended radiation exposure to patients, strict adherence to a daily eluate testing protocol is required. Stop using the rubidium (82Rb) generator when the expiration limits are reached (see sections 6.3 and 12). Records of the daily quality control test results must be maintained on file.
Risk of high level radiation exposure with the use of incorrect eluent
Only use additive-free sodium chloride 0.9% solution for injection to elute the generator. Additives present in other solutions (particularly calcium ions) may expose patients to high levels of radiation by causing the release of large amounts of 82Sr and 85Sr into the eluate regardless of the generator’s age or prior use.
Immediately stop the patient infusion and discontinue use of the affected RUBY-FILL generator if the incorrect eluent is used and evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow.
When solutions containing calcium ions are used to elute the generator, high levels of radioactivity may be present in the eluate, even with the subsequent use of additive-free sodium chloride 0.9% solution for injection.
Operation Automation
Safety
- Automated safety alerts and how they minimize risk of strontium breakthrough.
- System lockout denies access to patient infusion controls if quality control is not completed or if strontium levels are elevated.
- No need to record dose calibrator readings or manually calculate strontium breakthrough detection.
Efficiency
- Automated quality control and reports.
- Enhanced maneuverability.
- Stick-on printed patient infusion labels.
- 30 L generator volume.
Engineered for User Confidence & Efficiency
- 30L generator volume for flexible capacity.
- Long 60-day shelf life.
- Enhanced maneuverability.
Accurate Patient-Specific Infusion Options
- Weight-Based Dosing.
- Constant-Activity Options.
- Reduces test-retest variability.
EU Authorized Distributor:
Cyclomedica Europe Limited
Unit A5, Calmount Business Park
Ballymount D12 AX06, Ireland
EU Authorized Representative:
EMERGO EUROPE
Westervoortsedijk 60
6827 AT Arnhem
The Netherlands
The current Instructions for Use (IFU) are available to RUBY-FILL users by request. For assistance obtaining the IFU, please contact Customer Support at 1-877-782-9345.