Operation Manual Contrast Injection System
MEDRAD® Salient Operation Manual i
ii MEDRAD® Salient Operation Manual
MEDRAD® Salient Operation Manual Contents 1. Quick Start ...................................................................................................................................................... 1 2. Introduction .................................................................................................................................................... 3 2.1. Important Safety Notice .....................................................................................................
MEDRAD® Salient Operation Manual ii 5.1. Turning the System On for the First Time ........................................................................................... 26 5.2. Syringe, Quick Fill Tube, Fill Spike, and Connector Tubes ................................................................ 27 5.2.1. Description and Part Number ..................................................................................................... 27 5.2.2. Syringe MEDRAD® FluiDots .......................
MEDRAD® Salient Operation Manual 5.10.7. Arming ....................................................................................................................................... 54 5.10.8. Check for Air.............................................................................................................................. 54 5.10.9. Starting the Injection .................................................................................................................. 55 5.10.10.
MEDRAD® Salient Operation Manual iv 8. Specifications ............................................................................................................................................... 84 8.1. Dimensions .......................................................................................................................................... 84 8.2. Mechanical ...................................................................................................................................
MEDRAD® Salient Operation Manual v
MEDRAD® Salient Operation Manual 1.
2 MEDRAD® Salient Operation Manual
MEDRAD® Salient Operation Manual 2. 3 Introduction Thank you for purchasing the MEDRAD® Salient Contrast Injector. Read this manual and follow the safety precautions closely so you will be able to use the injector and all of its features properly and safely. For the latest support information, visit our website: http://www.imaxeon.com/ Record the model number in the table below, together with the serial number of your system and your IMAXEON representative’s telephone number.
4 MEDRAD® Salient Operation Manual Imaxeon reserves the right to modify the specifications and features described herein, or discontinue manufacture of the product described at any time without prior notice or obligation. Please contact your authorised Imaxeon representative for the most current information. Imaxeon disclaims liability for any modifications or interfaces with other equipment, which are not in conformity with the specifications and information contained within this manual.
MEDRAD® Salient Operation Manual 2.8. Imaxeon Contact Information 2.8.1. Manufacturer Imaxeon Pty. Ltd. Unit 1, 38-46 South St, Rydalmere, NSW, 2116 Australia T: +61 2 8845 4999 F: +61 2 8845 4936 www.imaxeon.com info@imaxeon.com 2.8.2. EC Representative Bayer Medical Care B.V.
MEDRAD® Salient Operation Manual 6 2.9. SYRINGE - Warnings and Cautions 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. WARNINGS ♦ Correctly load the syringe. Improper loading may cause an under volume delivery, air embolization or personal injury.
MEDRAD® Salient Operation Manual ♦ Patient injury could occur if the on-screen manual fill controls are used when the patient is connected. This could cause injury to the patient by delivery of contrast or blood extraction and may require the procedure to be repeated. ♦ A possible explosion risk exists if the injector is used in the presence of flammable anaesthetics with air or oxygen or nitrous oxide. ♦ Regular maintenance should be performed.
MEDRAD® Salient Operation Manual 8 ♦ Line voltage hazard. To avoid dangerous voltages, do not remove the IEC connector (base cable) while line power is applied to the injector. Always disconnect the injector from line power before removing the IEC power connector. ♦ Do not position the injector pedestal by pulling on the injector head, display or cabling. Possible injury can occur if the injector head or stand falls on the patient or technician.
MEDRAD® Salient Operation Manual ♦ 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.
MEDRAD® Salient Operation Manual 10 3. Getting Started 3.1. 1. Installation 2. A B A C 3. 4. B C 5. 6.
MEDRAD® Salient Operation Manual 3.2.
MEDRAD® Salient Operation Manual 12 3.2.1. Injector Head Description The injector is a modern, microprocessor-controlled powered injector system. Syringe Bayonet Fitting Touchscreen Syringes are loaded into the injector with a simple bayonet locking system. Filling the syringes is accomplished with both manual and automatic (preset volume) powered options on the injector itself. After loading the syringes, the user interacts with the injector primarily via a colour touch screen interface.
MEDRAD® Salient Operation Manual 3.3. Symbols 3.3.1. Symbols used in this manual Warnings advise of circumstances that could result in injury or death to the patient or operator. Read and understand all warnings before operating the injector. Consult accompanying documents/text. The symbol is located throughout this manual and on the injector labelling as required.
MEDRAD® Salient Operation Manual 14 Identifies location for connection of the START switch - either a hand-switch or footswitch can be connected. The symbol is located on the base power panel Name and address of the manufacturer Manufacturing Date (YYYY-MM) Consult instructions for use.
MEDRAD® Salient Operation Manual 3.3.4. Icons and Buttons used on the Injector Touch Screen Graphical Interface Note: The touchscreen does not have multi-touch functionality. To avoid incorrect input, please touch one control at a time Identifies that line power is connected to the injector Identifies that system is running on batteries. Animates during charging, and shows empty/full status Back or Previous - navigation. Also halts paused or held injections and cancels editing operations.
MEDRAD® Salient Operation Manual 16 Manual Fill Controls for manual fill/purge of contrast or [Dual Only] saline. Larger gradations indicate higher fill/purge speed, and the arrows indicate the direction of the piston (On-screen) Start Injection button (On-screen) Stop Injection button Display Pressure Graph (toggle button). During injection, the screen can be switched between showing the syringe indicators to a real-time pressure graph of the current injection phase.
MEDRAD® Salient Operation Manual 3.3.6. 17 Remote Control Symbols and Buttons Battery Low LED - If the battery is low this light will shine continuously and the remote will emit a beep. If this occurs the batteries should be replaced. See Section 6.2.2. Transmitting LED - When lit, this LED indicates that the remote is transmitting to the injector. The light may also come on when the red or green button is pressed, but this is not an indication of a low battery.
MEDRAD® Salient Operation Manual 18 3.3.8. Icons and Buttons used on the RCU Touch Screen Graphical Interface Injector Controller Action Menu RCU Manager – return to RCU manager screen GFR Calculator: Uses the Modification of Diet in Renal Disease (MDRD) Study equation to estimate an appropriate contrast dose based on patient parameters. Saved Protocols: View and select saved injection protocols stored on the RCU. Save As Protocol: Save the current protocol under another protocol name.
MEDRAD® Salient Operation Manual 19 Power Status Battery Low Battery half Battery full Mains power Filling/Injection Status Injector is in filling status Injection in progress
MEDRAD® Salient Operation Manual 20 RCU Manager Injector Controller: This is the application used to control the paired injector. History Viewer: Stored injections performed while the RCU was interfaced with the injector is stored in the RCU memory and can be reviewed from this application Protocol Manager: Protocols can be saved or restored from a removable USB memory drive.
MEDRAD® Salient Operation Manual 21
MEDRAD® Salient Operation Manual 22 4. Clinical Information 4.1. Cannula and Needle Selection Cannulas or I.V. catheters are the preferred choice for injecting contrast agents with powered injectors. The following chart shows the maximum flow rate that is possible with typical gauge cannulas. However, operating the injector at or close to maximum flow rate may lead to adapted (reduced) flow, which may result in suboptimum images.
MEDRAD® Salient Operation Manual 23 4.2. Understanding pressure and flow, pressure limiting & adaptive flow 4.2.1. Pressure Basics In all hydraulic systems, pressure is required to cause fluid to flow through the conduit. The pressure in the reservoir (syringe) must exceed the resistance of the conduit (tubing and catheter) and fluid. The conduit offers resistance by its diameter and length. The fluid offers resistance by its thickness, or viscosity.
MEDRAD® Salient Operation Manual 24 4.3. Adaptive Flow, Pressure Limit and Over Pressure At normal injection pressures, the injector will maintain the programmed flow rate. The x-ray image should display good contrast and opacity. However, if the fluid path encounters a blockage, or if the connected disposables restrict the flow of contrast, the syringe pressure will rise.
MEDRAD® Salient Operation Manual 4.4. 25 Warming the Contrast: Heat Maintainer For improved patient comfort and lower viscosity, contrast manufacturers recommend warming contrast to body temperature before use (i.e. 37°C). It is also recommended that the contrast be warmed for at least 2 hours prior to use, because heat permeates contrast very slowly. Imaxeon provides a syringe heat maintainer part number DC022, which can be used to maintain the heat of the fluid in the syringe.
MEDRAD® Salient Operation Manual 26 5. Operation Description 5.1. Turning the System On for the First Time Plug in a power cable to the IEC socket and connect the cable to your mains supply. Ensure that the power switch in the pedestal base is in the On position, and that the circuit breaker is in-circuit (pushed in).
MEDRAD® Salient Operation Manual 27 5.2. Syringe, Quick Fill Tube, Fill Spike, and Connector Tubes 5.2.1. Description and Part Number The syringe is available in a 190 ml size, suitable for use with contrast and saline flushing agents.
MEDRAD® Salient Operation Manual 28 ZY5151: 150 cm Extension tube single 5.2.2. ZY5152: 150 cm Extension tube T-connector Syringe MEDRAD® FluiDots A fluid-filled syringe is easily checked by noting the shape of the MEDRAD® FluiDots on the side of the syringe. When viewed through fluid, MEDRAD® FluiDots indicators will appear larger and rounded. Viewed through an empty syringe, the indicators will appear small and narrow.
MEDRAD® Salient Operation Manual 5.2.3. 29 Mounting the Syringe Remove the syringe from its packaging. Mount the syringe into the injector bayonet fitting as shown and twist a quarter of a turn to lock it into place. If the injector is on, the syringe will automatically be detected. See Section 5.2.4. 5.2.4. Select Syringe New, unfilled syringe Syringe filled on offline loader (Section 5.4) The injector will detect this and automatically purge the syringe of air.
MEDRAD® Salient Operation Manual 30 5.3. Filling a Syringe Using a Quick Fill Tube (QFT) or Fill Spike on the Injector Syringes may be filled to a preset volume using the injector AutoFill functionality or to any arbitrary volume using the Manual fill controls. See Section 5.5 for details on connecting the tubing. If the syringe is removed after filing, the piston will auto-retract. [Using ZY6320, ZY6322, ZY6325] The syringe can be filled using a quick fill tube.
MEDRAD® Salient Operation Manual 5.3.1. Manual and Auto Filling Procedure Manual filling 1. 31 Integral AutoFill with a QFT Mount a new syringe on the injector 2. Select on the touch screen 3. The plunger will automatically purge the air from the syringe. 4. Push the QFT onto the end of the syringe. Do not install with excessive force 5. Insert the QFT into the fluid source and 6. Fill the syringe with fluid using the manual fill control. 7. Expel air 8. Remove QFT.
MEDRAD® Salient Operation Manual 32 5.4. [Optional] Off-line Filling Contrast can be filled off-line using the optional manually-operated Off-line Loader (MDL001). This can improve the workflow by freeing the injector to continue with other procedures. With the loader lever in the down position, mount a new syringe into the loader and twist a ¼ of a turn to lock it into place.
MEDRAD® Salient Operation Manual 33 2. Remove the connector tube from the package. Remove the proximal-end (orange) dust cover. 3. Attach the connector tube to the syringe, ¼ turn to ½ turn maximum. 4. Once secured, verify that the tubing is not kinked or obstructed. 5. [Dual only] If you are using a connector tube with a T-connector, attach the straight portion of the T-connector to the contrast (Syringe A) and the extension to the saline (Syringe B).
MEDRAD® Salient Operation Manual 34 5.7. Performing an injection Pressing , when on the filling screen displays the current protocol screen. The routine protocol screen is described in Section 5.7.1. More complicated multi-phase protocols may also be entered; see Section 5.8. 5.7.1. Routine Protocol Setup The routine protocol is a simple injection protocol which delivers one phase. The volumes and injection rates entered on this screen are not remembered by the injector when it is powered off.
MEDRAD® Salient Operation Manual 5.7.2. 35 Arming Press the on the injector head to ARM To disable the ARM state, press The injector will time out of the ARM state if the injection is not started within 10 minutes and will return to the protocol screen. Check for air. Press the OK button on the touch screen. The injector is now ready to begin injecting, and the LEDs in the rear of the head module will flash green to reflect this fact.
MEDRAD® Salient Operation Manual 36 5.7.4. Starting the Injection Injections may be started using the pressing the green button on the supplied remote control, or the green start button on the touch screen. An optional hand-switch or footswitch can also be used to initiate injections. Start Button Pause Button The start button does not need to be held down during the injection. 5.7.5.
MEDRAD® Salient Operation Manual 5.7.6. 37 Common Injecting Alarms During an injection, the most likely alarms to occur which result in the injection halting are caused by high pressure or the adaptive flow algorithm slowing the injection speed down to zero (known as a stall alarm). When these alarms occur, the top part of the screen (the status bar) will flash red and the LEDs at the back of the injector head will illuminate red.
MEDRAD® Salient Operation Manual 38 5.7.7. Post-Injection Review When the injection has completed a summary of the injection details is displayed. The average flow rate, peak pressure and duration are calculated based on the combined contrast/saline injection (including all phases in a multi-phase injection). If the syringe is manually removed at this stage, the piston will automatically retract.
MEDRAD® Salient Operation Manual 5.7.7.1. [Dual Only] Post-injection Review The contrast and saline injection volumes are separately indicated. The average flow, peak pressure and duration are over the combined contrast/saline injection.
MEDRAD® Salient Operation Manual 40 5.8. Programming The injector can be programmed to deliver up to 4 sequential phases of contrast injections, hold phases or delays. The multi-phase programming mode is entered by pressing the load protocol button protocol screen and loading any protocol except the routine protocol. 5.8.1. on the routine Multi-phase protocol setup Phase 1 Phase 2 etc Alter phase type (see §5.8.
MEDRAD® Salient Operation Manual 5.8.3. Phase Type Selection Contrast injection Pause phase for a set time Hold (press >> to continue) Delete this phase Cancel (do not save changes) 5.8.4.
MEDRAD® Salient Operation Manual 42 5.8.5. Protocol Selection – Loading Pressing on either of the routine protocol or multi-phase protocol screens will cause the injector to display a list of the stored protocols. Select a protocol name you wish to load. Routine protocol Press protocol name to load Current protocol Back to previous screen (cancels load operation) “Load Protocol” icon Sort protocols – toggles between alphabetically and numerically The protocols are saved in numerical slots.
MEDRAD® Salient Operation Manual 5.8.6. 43 Protocol Selection – Saving Pressing on the multi-phase protocol screen will cause the injector to display a list of the stored protocols. Select a protocol name where you want the current protocol to be stored and the injector will then prompt you to enter a new name for the stored protocol. The routine protocol cannot be saved over. Use the options menu to change its settings (§5.
MEDRAD® Salient Operation Manual 44 5.9.
MEDRAD® Salient Operation Manual 45 RCU Connection Setup: Enable or disable the connection to the RCU. See Section 5.9.2 Service menu: Enter service menu (requires password) Previous Options screen Back to Start screen 5.9.1.
MEDRAD® Salient Operation Manual 46 5.9.2. [RCU models] RCU Connection Setup Pressing the RCU Connection Setup displays the configuration for the wi-fi connection. The Wi-Fi connection can be enabled/disabled as required. (The Type setting cannot be changed). The NetID should be set to match that selected on the RCU (see Section 5.9.2).
MEDRAD® Salient Operation Manual 5.9.3. 47 Autofill Default Options These options govern the behaviour of the autofill feature on the fill screen. Note that only the autofill volume can be changed on the fill screen. The shuffle volume and the fill speed will always be set to the values entered here. If the autofill volume is changed on the fill screen, the new value will remain in effect until the injector is powered off and on again, when the default value on this options screen will be reloaded.
MEDRAD® Salient Operation Manual 48 5.10. [RCU models] Operation Description with Remote Control Unit This section covers the operation of the models: ♦ DC009SW ♦ DC009DW In these models, the function of the injector can be controlled by a tablet PC, remotely-connected to the injector via peer-to-peer Wi-Fi connection. The functionality of the injector is identical to that of the non-RCU models DC009S and DC009D. 5.10.1.
MEDRAD® Salient Operation Manual 5.10.2. The Injector and the RCU The RCU is designed to provide continuous status information on the injector, and full control of the injector 4. When connected with either a single or dual syringe model injector, the RCU will display the parameters and controls appropriate to that model. 5.10.3. Turning the System On / Off The RCU is powered on by pressing the “Power Button” shown in Section 5.10.1.
MEDRAD® Salient Operation Manual 50 5.10.3.1. Injector Link Status RCU Manager updates the link status in real time. It is important to ensure the link is connected before start controlling injector. Disconnected. RCU will attempt to connect to the injector if no connection is found. Connected. Number of segments reflects the strength of signal. Communication Issue. The selected channel is already being used, or the wrong protocol version is used. 5.10.3.2.
MEDRAD® Salient Operation Manual 5.10.4. 51 Injector Controller Application Injection elapsed time Date and Time Routine Protocol RCU Manager Injector Link Status ISI Status Power Status Injector Status Syringe status Injector S/N LED / Alarm Injector Frame Action Menu Arm Injector Injector Controller Action Menu GFR Calculator: Uses the Modification of Diet in Renal Disease (MDRD) Study equation to estimate an appropriate contrast dose based on patient parameters.
MEDRAD® Salient Operation Manual 52 5.10.4.2. Injector and Syringe Status, Alarms and Indicators RCU displays current injector and syringe status in real time in 500ms intervals. For Single injector models, only one syringe icon will be displayed Syringe Status parameters are: ♦ Filled volume ♦ Flow rate ♦ Pressure ♦ Injection volume indicator: displayed while in ‘Protocol Edit Screen’ [Dual Only]. If the RCU is interfaced to a Dual injector, both syringes are shown.
MEDRAD® Salient Operation Manual 53 Power Status Battery Low Battery half Battery full Mains power Filling/Injection Status Injector is in filling status Injection in progress 5.10.4.3. Elapsed Time RCU displays the elapsed time since the last injection start. Format is and updated every 1 second. The time value is reset when new syringe is engaged or by pressing the timer display and holding for 2 seconds.
MEDRAD® Salient Operation Manual 54 5.10.6. Routine Protocol Change the flow rate, volume and pressure limit of the routine protocol, if required, by pressing the buttons and entering the desired values. Flow Rate The injection duration is automatically calculated. Volume Pressure limit [Dual Only] Program parameters as required. 5.10.7. the contrast and saline Arming When the protocol has been programmed, press the button to arm the injector.
MEDRAD® Salient Operation Manual 5.10.9. Starting the Injection Review the protocol displayed. Select the button on ‘Start Injection’ Screen.
MEDRAD® Salient Operation Manual 56 5.10.10. Injection in Progress The injection can be monitored in progress from the RCU. While an injection is in progress, the RCU will: Update the plot display (flow rate and pressure) in real time Display the injection progress information in real time Play LED animation Play injection sound If the button is pressed, the injection is paused.
MEDRAD® Salient Operation Manual 57 5.10.11. Injection Control Buttons If for any reason, the injection needs to be paused or aborted, select the RCU injection control button on the Injection in Progress screen.
MEDRAD® Salient Operation Manual 58 5.10.12. Injection Review At the end of the injection, the details of the injection can be reviewed, either in plot format or table format. These formats can be toggled using the or buttons. Plot format Table format 5.10.12.1. Injection Review Control Buttons Injection Review Table Mode Injection Review Plot Mode 5.10.12.2.
MEDRAD® Salient Operation Manual 59 5.10.13. Protocol Edit Multiphase injections can be programmed and saved Edit protocol type Protocol name Edit phase parameters Edit max pressure Summary Arm Protocol Save Protocol Open [Dual only] The Dual model injector will display the protocol for both syringes Protocol Summary View shows: ♦ Overall phase information in terms of time. ♦ Overall phase information in terms of volume.
MEDRAD® Salient Operation Manual 60 5.10.14. Edit Lock The injector and RCU do not allow the user to edit protocol parameters simultaneously; only one device is allowed to enter ‘edit mode’. The other device is locked while editing is performed. When RCU is locked ‘Edit Lock’ icon is displayed in Injector Status frame and will not respond to any button press events that are related to editing protocol parameters. Edit Lock Protocol being edited on the RCU – Injector is locked.
MEDRAD® Salient Operation Manual 61 5.10.17. Edit Phase Type Each phase can be programmed to be one of four phase types.
MEDRAD® Salient Operation Manual 62 5.10.18. Open Protocol A previously saved protocol can be loaded by selecting the tap on the protocol desired. button. Scroll through the saved protocols and 5.10.19. Protocol Save The current programmed protocol can be saved to a new protocol slot by pressing the through the list to select the protocol slot desired. button.
MEDRAD® Salient Operation Manual 63 5.10.20. Common Injecting Alarms / Warnings During an injection, the most likely alarms to occur which result in the injection halting are caused by high pressure or the adaptive flow algorithm slowing the injection speed down to zero (known as a stall alarm).
MEDRAD® Salient Operation Manual 64 5.10.21. RCU Manager RCU Manager provides interface to: ♦ Launch RCU Application ♦ Manages wireless/wire connection to injector ♦ Setup / Configuration ♦ Provide service menus ♦ View videos and software information Injector Controller: This is the application used to control the paired injector. This application is set to run as default at start-up. This can be changed in the RCU Setup – Injector Controller screen (see Section 5.10.
MEDRAD® Salient Operation Manual 65 5.10.22. RCU Setup Press the button on the Action bar to access the setup options Configure the wireless link to the injector. The Wireless ID should match that set on the injector (see Section 5.9.2). [Optional] Enable or disable the interface between the RCU and the scanner (see Section 5.11). Set the screen brightness. Set the volume of the RCU sounds. Select from the available languages.
66 MEDRAD® Salient Operation Manual Injection history can be downloaded to any formatted USB stick. (Reminder screen). Change the date and time of the system on the injector. Additional software features, if enabled, can be turned on or off. Premium Features can only be enabled by an Imaxeon service or sales representative. Enabling PACS will display a set of configuration options to enable connection to the hospital network. Consult your onsite IT for the appropriate settings.
MEDRAD® Salient Operation Manual 67 5.10.23. History Viewer From the RCU Manager, press the to view the details of recent injections. Injection Review Table Mode Injection Review Plot Mode Delete Injection Record Export Injection History Data Note: Only injections recorded while the RCU is connected to the injector and controlled from the Injector Controller screen are stored in the RCU. Injections performed by the injector while disconnected from the RCU are not stored on the RCU.
MEDRAD® Salient Operation Manual 68 5.10.24. Protocol Manager Injection protocols can be saved to and from USB memory devices. 5.10.24.1. Saving Protocols ♦ Plug in the formatted USB device into an available USB port on the RCU. ♦ From the RCU Manager, press the ♦ Select the Injector-to-USB download as shown below and press 5.10.24.2. button Loading Protocols ♦ Plug in the USB device containing the saved protocols into an available USB port on the RCU.
MEDRAD® Salient Operation Manual In adults, the best equation for estimating glomerular filtration rate (GFR) from serum creatinine is the isotope dilution mass spectrometry (IDMS)-traceable Modification of Diet in Renal Disease (MDRD) Study equation. 6 All laboratories should be using creatinine methods calibrated to be IDMS traceable. This IDMS-traceable MDRD study equation calculator is for use with Scr reported in mg/dL. GFR (mL/min/1.73 m2) = 175 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.
MEDRAD® Salient Operation Manual 70 5.11. [Optional] DC200 Scanner Interface The Imaging System Interface (DC200) is an option that allows the injector to interface with a CT scanner. It obtains its power from the injector Remote Control Unit option USB port. It interacts with the injector and scanner through direct cable connections.
MEDRAD® Salient Operation Manual 5.11.2. 71 DC200 Scanner Interface Setup Connect the DC200 module to the RCU using the USB cable provided. USB RCU DC200 Connect the DC200 module to the scanner using an appropriate cable (Philips or Hitachi – consult your Imaxeon sales or service representative) Enter the RCU Options screen. Select and enable the ISI.
MEDRAD® Salient Operation Manual 72 On the protocol screen the following icon should be displayed, indicating that the DC200 module is connected to the RCU. NOTE: If the DC200 module is disconnected from the RCU and ISI is enabled in the options, the icon on the protocol screen will change as follows Note: The ISI status icon described above does not and cannot indicate if the scanner is connected to the DC200 module correctly.
MEDRAD® Salient Operation Manual 5.11.3. Inject or Scan Delay The injector can start the injection before the scanner (scan delay), or the scanner can start the scan before the injection (inject delay). 1. Follow the scanner manufacturer’s instructions for enabling ISI. 2. Program the scanner. 3. Program the injection protocol into the injector. Once the protocol has been programmed, press the ARM button on the injector head or the RCU. 4. Check the fluid pathway for air.
MEDRAD® Salient Operation Manual 74 5.12. [Optional] Protocol Assistance Tool (PAT) This option can only be enabled by an Imaxeon service or sales representative. The PAT application provides the user with suggested weight based injection protocols for a range of common CT examinations. It is available only with the optional Remote Control Unit RCU. The PAT is intended to be used as a guide. It is not intended to replace clinical experience and judgment.
MEDRAD® Salient Operation Manual 75 For CTA Type protocols, select MDCT Number and select the scanner multi detector slice number from the available options: 4, 16, 64 & 128 MDCT. Note, this parameter is not available for Routine type protocols as it is not required to calculate contrast media dosing. Once all of the parameters are entered, select the green tick to generate a suggested protocol Or select the back arrow to exit . .
MEDRAD® Salient Operation Manual 76 6. Cleaning and Maintenance 6.1. General Cleaning Procedures The injector should be switched off and disconnected from the mains supply before cleaning. The covers and external parts of the injector should be cleaned using warm soapy water and a soft cloth. Do not use abrasive cleaning aids, solvents or alcohol wipes. X-Ray contrast tends to dry quite hard and hence should be wiped off as soon as possible.
MEDRAD® Salient Operation Manual 6.2. Battery Maintenance 6.2.1. Injector Batteries Warning: The injector batteries should be replaced only by suitably qualified service technicians. Replacement should not be attempted by users or their (untrained) service personnel. The batteries should be checked at each annual preventive maintenance event for signs of enclosure warping or content leakage. Expected useful battery life is 2-4 years.
MEDRAD® Salient Operation Manual 78 6.3. Recommended Regular Check Procedure 6.3.1. Monthly Once a month, the entire injector should be thoroughly inspected and cleaned and an operational checkout procedure should be performed. Refer to Section 6.3.3 for the checkout procedure. 6.3.2. Annual Check WARNING A complete injector calibration and performance checkout should be carried out once a year by an authorised Imaxeon Service Representative.
MEDRAD® Salient Operation Manual 6.3.3. 79 Operator Checkout Procedure The following checkout procedures test the major functions of the injector and should be completed before using the injector for the first time or as a monthly routine preventive maintenance program. If a problem or a calibration error is suspected, use this procedure for troubleshooting before contacting IMAXEON Service.
MEDRAD® Salient Operation Manual 80 20. Switch off the mains rocker switch on the base of the unit. Ensure that the battery symbol is displayed at the top of the injector display screen. 6.4. Disposing of the Injector The symbol shown below indicates the product must not be disposed of with other waste. Instead, it is the user’s responsibility to dispose of the product by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment.
MEDRAD® Salient Operation Manual 81
MEDRAD® Salient Operation Manual 82 7. Trouble-shooting 7.1. Fault Finding Guide Symptoms Actions Injector does not power up 1.Check that circuit breaker is pressed in 2.Connect AC mains cable 3.Replace batteries 4.Contact Imaxeon Service Injection stops mid-way through an injection 1.Check for kink in giving set tubing 2.Check for cannula placement and possible arterial occlusion from patient arm position 3.Check battery health 4.
MEDRAD® Salient Operation Manual 7.1.1. 83 [RCU Models] Trouble-Shooting Symptoms Actions Unit will not connect to injector Select a different Wireless ID on both the RCU and injector system and try to connect again. RCU will not turn on Check the power supply is connected to the RCU. Loading/Saving Protocols Fails Check that a formatted USB memory device is inserted into the RCU.
MEDRAD® Salient Operation Manual 84 8. Specifications 8.1.
MEDRAD® Salient Operation Manual 8.2. 85 Mechanical Weight 22.9kg (Single) 25.5 kg (Dual) Height 1315 mm Floor Area 500mm x 500mm No of Wheels 4, locking Type of Wheel Rubber Castor, ball bearing race Construction Materials Flame retardant ABS panels, Aluminium, Steel Operating Noise Level < 95 dBA 8.2.1. [RCU Tablet] Mechanical Weight 1kg Dimensions 296(W) x 217(H) x 24.1(D) mm 8.2.2. [DC200] Mechanical Weight 0.5 kg Dimensions 120mm x 60mm x 30mm 8.3.
MEDRAD® Salient Operation Manual 86 8.4. Controls Pedestal Line power ON/OFF, double pole switch IEC power inlet, double fused Circuit Breaker 3A max Injector Head Touchscreen Fill control Protocol Programming Injector buttons Power on/off Arm Remote control Start/stop injection Hand-switch or footswitch Start/stop injection 8.5.
MEDRAD® Salient Operation Manual 8.6. 87 Electrical Line Voltage 100-230 V~ ±10% Line frequency 50/60 Hz Phase Single Charging AC only Operating Batteries or AC Max Current Consumption, Operating 2.0A peak Max Current Consumption, Standby 0.5A or less Consumption, Charging from mains 1A maximum Current Surge (inlet fuse) Rating 2A maximum Battery Voltage 12VDC Battery type Imaxeon 12 V7.
MEDRAD® Salient Operation Manual 88 8.7. Connectors Head Cable 26-way D sub-miniature Hand/Foot Switch Circular, locking. 3 pin XLR Line Power IEC 60320-C14 Equipotential Point MC POAG-S6 SERIES Syringe Heater 4 pin Mini-DIN 8.8. IEC 60601-1 Classifications The Injector is classified as follows: ♦ Class 1 equipment with Type BF applied parts. ♦ Internally Powered Equipment ♦ IPX0 (Injector and hand-switch) Clause 6.
MEDRAD® Salient Operation Manual 8.11. 89 IEC60601-1-2:2014 (4th Ed) Compliance 8.11.1. Electromagnetic Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The injector is suitable for use in the electromagnetic environment specified below. The customer or the user of the injector must ensure that it is used in such an environment.
MEDRAD® Salient Operation Manual 90 Immunity test IEC 60601-1-2 test compliance level Electromagnetic environment guidance Portable and mobile RF communication equipment should be used no closer to any part of the Salient contrast injector than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: Conducted RF IEC 61000-4-6 3 Vrms at 1kHz 80% AM 150 kHz to 80 MHz d = 1.
MEDRAD® Salient Operation Manual 91 8.11.3. Recommended separation distances from portable and mobile RF communications equipment and the injector Recommended separation distances from portable and mobile RF communications equipment and the injector The injector is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
MEDRAD® Salient Operation Manual 92 8.12. Models Model Number Description DC009S MEDRAD® Salient Contrast Injector Single DC009D MEDRAD® Salient Contrast Injector Dual DC009SW MEDRAD® Salient Contrast Injector Single with Wireless RCU DC009DW MEDRAD® Salient Contrast Injector Dual with Wireless RCU 8.13. Accessories Accessory (shaded options are included standard with each injector) Part number 1. Power Cord WP0023 WP0020 WP0021 WP0016 WP0015 WP0019 WP0022 WP0024 WP0009 WP0025 WP0033 2.
MEDRAD® Salient Operation Manual Operator Manual 93 MN040010 English MN040002 Chinese MN040003 French MN040004 Italian MN040005 German MN040009 Spanish MN040016 Russian MN040017 Portuguese MN040018 Greek MN040019 Hungarian MN040020 Croatian MN040021 Czech MN040022 Danish MN040023 Dutch MN040024 Korean MN040025 Polish MN040026 Romanian MN040027 Slovak MN040028 Slovenian MN040029 Swedish MN040030 Turkish MN040032 Bulgarian MN040035 Serbian MN040066 Latvian MN040067 Lithuanian MN040068 Finnish MN040069 Norw
MEDRAD® Salient Operation Manual 94 9.
MEDRAD® Salient Operation Manual Removing, 34 Reuse, 6 syringe heat maintainer, 9 Time, 17 Trademarks, 3 Trapping hazard, 9 Trouble-shooting, 83 Tube, 28, 34 95 Under flow rates, 6 Under volume, 6 USB Device, 69 Warnings, 7, 14 WEEE, 9, 14 wheel, 9 Wi-Fi, 49 Wireless Link, 51
MEDRAD® Salient Operation Manual 96 © 2019-2020 Bayer. This material may not be reproduced, displayed, modified or distributed without the express prior written consent of Bayer. Bayer, the Bayer Cross, Imaxeon, MEDRAD FluiDots, MEDRAD Salient, MEDRAD, Salient and FluiDots are trademarks owned by and/or registered to Bayer in the U.S. and/or other countries. In accordance with data privacy and protection laws in Australia and other countries, all patient data that appear in this document are fictitious.
MEDRAD® Salient Operation Manual 97
