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
MEDRAD
®
Salient Operation Manual 9
♦ Injector may disarm or fail to operate when exposed to high magnetic fields. Do not use radio
transmitters, cellular phones or devices generating electrostatic discharge in the vicinity of the injector.
♦ The syringe heat maintainer may be hot when in operation. Avoid holding the heat maintainer when
in operation.
♦ The base cover may be damaged by impact. This may also damage the components in the base.
Avoid stepping on the base cover.
♦ Moving the injector may cause risk of catheter pull-out during injection. When injecting, lock the
wheel castors, and prevent the injector head from moving. When moving the injector again, ensure the
castors are unlocked, to avoid the injector tipping over.
♦ Trapping hazard. Be wary of retracting the piston of the injector head with syringes
removed. Fingers can be trapped by the mechanism causing minor injuries.
♦ Damage to the optional heat maintainer (DC022) can occur if it is connected to any device other
than the injector heat maintainer connector.
♦ Pushing the injector at the top of the head bracket may cause the injector to tip. Move the injector
by holding and pushing by the injector handle only
♦ [Wi-Fi Enabled models] Safe distance from medical equipment. The injector has an output wireless
power rating of less than 0.01W. Consult the documentation of your X-ray scanner for the
recommended separation distance for equipment of this power rating. Imaxeon recommends
maintaining at least 0.5m between the injector and scanner electronics.
♦ [Wi-Fi Enabled models] Keep the RCU unit including the power supply away from liquids. The
RCU is not designed to have liquids splashed on it or to be immersed.
♦ [Wi-Fi Enabled models] Keep the RCU plugged into mains power at all times. The tablet does have
a backup battery for emergency situations but this should only be used for short periods of time. The
RCU is intended to be used on mains power during operation.
2.10.1. [RCU models] Glomerular filtration rate (GFR) Calculator Warnings
♦ Calculation of the risk factor for contrast media dose using the RCU eGFR calculator are
estimates, and should be used by trained personnel only. The calculator assesses the risk based on
patient parameters entered by the operator and the isotope dilution mass spectrometry (IDMS)-traceable
Modification of Diet in Renal Disease (MDRD) Study equation. The clinician should use the result, in
combination with clinical experience to decide on the dose and separately program the volume into the
injection protocol.
♦ No injection parameters are modified by the injector automatically as a result of the GFR
calculation. The injection protocols should be adjusted by the operator.
♦ The eGFR calculation is not recommended for paediatric patients. The MDRD is only
recommended for adult patients.