Operation Manual
Table Of Contents
- 1. Quick Start
- 2. Introduction
- 3. Getting Started
- 3.1. Installation
- 3.2. Injector Features
- 3.3. Symbols
- 3.3.1. Symbols used in this manual
- 3.3.2. Symbols used on labelling
- 3.3.3. Handswitch and Footswitch
- 3.3.4. Icons and Buttons used on the Injector Touch Screen Graphical Interface
- 3.3.5. Injector Buttons
- 3.3.6. Remote Control Symbols and Buttons
- 3.3.7. Injector Visual Indicators
- 3.3.8. Icons and Buttons used on the RCU Touch Screen Graphical Interface
- 4. Clinical Information
- 5. Operation Description
- 5.1. Turning the System On for the First Time
- 5.2. Syringe, Quick Fill Tube, Fill Spike, and Connector Tubes
- 5.3. Filling a Syringe Using a Quick Fill Tube (QFT) or Fill Spike on the Injector
- 5.4. [Optional] Off-line Filling
- 5.5. Connector Tube Installation
- 5.6. Dismounting a Syringe
- 5.7. Performing an injection
- 5.8. Programming
- 5.9. Options Menu
- 5.10. [RCU models] Operation Description with Remote Control Unit
- 5.10.1. RCU Features–
- 5.10.2. The Injector and the RCU
- 5.10.3. Turning the System On / Off
- 5.10.4. Injector Controller Application
- 5.10.5. Filling State
- 5.10.6. Routine Protocol
- 5.10.7. Arming
- 5.10.8. Check for Air
- 5.10.9. Starting the Injection
- 5.10.10. Injection in Progress
- 5.10.11. Injection Control Buttons
- 5.10.12. Injection Review
- 5.10.13. Protocol Edit
- 5.10.14. Edit Lock
- 5.10.15. Parameter Value Edit
- 5.10.16. Injecting remaining volume
- 5.10.17. Edit Phase Type
- 5.10.18. Open Protocol
- 5.10.19. Protocol Save
- 5.10.20. Common Injecting Alarms / Warnings
- 5.10.21. RCU Manager
- 5.10.22. RCU Setup
- 5.10.23. History Viewer
- 5.10.24. Protocol Manager
- 5.10.25. eGFR (glomerular filtration rate) Calculator
- 5.11. [Optional] DC200 Scanner Interface
- 5.12. [Optional] Protocol Assistance Tool (PAT)
- 6. Cleaning and Maintenance
- 7. Trouble-shooting
- 8. Specifications
- 8.1. Dimensions
- 8.2. Mechanical
- 8.3. Functional
- 8.4. Controls
- 8.5. Environmental
- 8.6. Electrical
- 8.7. Connectors
- 8.8. IEC 60601-1 Classifications
- 8.9. Ground Continuity
- 8.10. RoHS Statement
- 8.11. IEC60601-1-2:2014 (4th Ed) Compliance
- 8.12. Models
- 8.13. Accessories
- 8.14. Manufacturer’s Software License Information
- 8.15. FCC Statement
- 9. Index
6 MEDRAD
®
Salient Operation Manual
2.9. SYRINGE - Warnings and Cautions
WARNINGS
♦ Correctly load the syringe. Improper loading may cause an under volume delivery, air embolization or
personal injury.
♦ Filled syringes, which are stored, can promote bacterial growth. Imaxeon syringes are intended to
be filled, and then used immediately. Discard all filled syringes, in particular when removed from the
injector for some period of time.
♦ Minimize the length of the fluid path from the syringe to the patient. The connection of additional
infusion systems/accessories to the central fluid path from the injector to the patient increases
resistance to flow. This could cause under flow rates, under volumes, or stall conditions which could
possibly cause the procedure to be repeated.
♦ Use extreme care when selecting flow rates to avoid the unintentional programming of an
inappropriate high rate injection. Always check settings before arming and injecting; high flow rate
i
njections may cause patient injury.
♦ Air embolization can cause patient injury or death; do not connect a patient to the injector until
all trapped air has been cleared from the syringe, connector tubing and catheter. Operator
vigilance and care, coupled with a set procedure is essential to the avoidance of air embolism.
♦ P
atient infection may result from the use of non-sterile components, do not remove plunger to fill
the syringe. Maintain sterility of all disposable components.
CAUTIONS
♦ The syringe may be damaged if hit with tools while attempting to eliminate air. Only use the palm
of hand to gently hit the syringe or pressure jacket to dislodge air bubbles.
♦ Ensure pressure settings are lower than catheter and connector ratings. Should an occlusion occur,
disposable components with a lower pressure rating may be subjected to pressure beyond their
capability, resulting in failure.
♦ T
he syringe heat maintainer incorporates a failure indicator light; if indicator light is lit while on
the syringe, remove the heat maintainer. This indicates that the syringe heat maintainer is faulty and
the built-in safety circuitry has disabled the heating mechanism.
♦ If the syringe plunger material fails, remove it from the injector immediately. The syringe is
considered an applied part according to the IEC 60601-1 standard. This means it is in electrical contact
with the patient via the fluid in the tubing. Any failure of the syringe plunger material may result in the
fluid making electrical contact with the injector system.
2.10. INJECTOR - Warnings and Cautions
WARNINGS
WARNING: A biological hazard may occur if syringes are reused.
Do not reuse the used syringe and fill tube with another patient. Properly dispose of the disposable in
accordance with your facility’s contaminated blood product disposable protocols.