Medrad Intego Operation Manual
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Medrad Intego Operation Manual

Pet infusion system
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Operation Manual
3031103 Rev. G

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  • Page 1 Operation Manual 3031103 Rev. G...
  • Page 3 Operation Manual © 2008 - 2013, MEDRAD, INC. All rights reserved. MEDRAD is a federally registered trademark and Performance. For life. is a trademark of MEDRAD, INC. U.S.A Unless otherwise indicated, all trademarks are owned by MEDRAD, INC. or licensed for its use.
  • Page 4 Medrad™ Intego™ PET Infusion System iiii...

  • Page 5: Table Of Contents

    Table of Contents Important Safety Notice to Users of the Medrad™ Intego™ PET Infusion System ......................vii 1 - Introduction ....................1 Certifications ........................1 Intended Use ........................1 Indications for Use ......................1 Restricted Sale ......................... 1 Trademarks ........................1 Disclaimers ........................
  • Page 6 Medrad™ Intego™ PET Infusion System Security Settings ......................37 4 - Daily Setup ....................39 Placing the System into Clinical Mode ................39 Using the Schedule ......................41 Manually Entering Schedule Information ..............42 Importing the Schedule Information via the USB Port ..........42 Editing the Schedule ....................
  • Page 7 Table of Contents Mobility of INT SYS 200 ....................103 Mobility of INT SYS 100 ....................104 Appendix C - Troubleshooting Tips ............105 Recovering from Priming Issues ................... 105 Recovering from Activation of Air Detector ..............105 During Priming ...................... 105 During a Saline Test Inject ..................
  • Page 8 Medrad™ Intego™ PET Infusion System vivi...

  • Page 9: Important Safety Notice To Users Of The Medrad™ Intego™ Pet Infusion System

    The safe and effective use of the Intego™ PET Infusion System to a large degree depends upon factors solely under the control of the medical professionals using the system. There is no substitute for a properly trained and vigilant device user.
  • Page 10 Medrad™ Intego™ PET Infusion System viiiviii...

  • Page 11: Introduction

    Intego™ PET Infusion System complies with the requirements of the standard IEC 60601-1-1. To obtain on-site consulting or consulting references, contact MEDRAD. This manual applies to the Intego™ PET Infusion System, Catalog Numbers INT SYS 200 and INT SYS 100. Read all the information contained in this manual. Understanding this information assists in operating the Intego™...

  • Page 12: Contact Information

    Symbols and Icons The symbols and icons discussed in the sections below describe the requirements to which the Intego™ PET Infusion System conforms, how warnings are displayed in the manual, and the icons used on the equipment and equipment packaging.
  • Page 13 1 - Introduction Indicates separate collection for electrical and electronic equip- ment per directive 2002/96/EEC. The Intego™ PET Infusion System is a Class 1 electrical device as CLASS 1 determined by IEC 60601-1. Radiopharmaceutical ( F-FDG or F-NaF). Stop button.

  • Page 14: Warnings

    Medrad™ Intego™ PET Infusion System Label showing the correct and incorrect direction to attach the Needle Cartridge into the Needle Cartridge Holder. Label showing the correct and incorrect insertion of the tubing into the Air Detector. Label showing the correct and incorrect orientation of the T- Connector and the tubing in each of the Pinch Valves.

  • Page 15: Display Icons

    Radiation exposure hazard. Both symbols indicate that opening the Shielded Chamber when there is RP in the Intego™ PET Infusion System could expose the operator or patient to radiation. DO NOT place greater than 1000 ml Saline Container on the Saline Hook.

  • Page 16: Status Indicators

    Partial infusion delivered. Complete infusion delivered. Status Indicators The following Status Indicators are used on all Intego™ PET Infusion Systems. System Power and Dose Calibrator Status (Green) On – Intego™ PET Infusion System is On and Dose Calibrator is ready for use.

  • Page 17: Packaging

    Blinking – Low Drive System battery – Approximately 3 minutes or less remain before the Drive System becomes unavailable for use. Connect the Intego™ PET Infusion System to AC power. Off – Drive System is not available for use. NOTE: The Shielded Chamber Lid must be closed and latched in order to use the Drive System.
  • Page 18 Medrad™ Intego™ PET Infusion System Fluid path sterilized with Ethylene Oxide. Use by date. Atmospheric pressure range. 100% RH Humidity range. 5% RH +60 C Temperature range. -20 C Contains DEHP. Do not stack. This side up. Keep dry. Fragile.

  • Page 19: System Basics

    Capability to retain and print infusion history and dispensing records. The Intego™ PET Infusion System is a self-contained, self-powered (available only on INT SYS 200) mobile cart. A Multi-Dose Vial of RP (up to 27.75 GBq (750 mCi)) is stored within a Shielded Chamber within the body of the system.

  • Page 20: Safety Features

    Multi-Dose Vial for each patient. • Prior to infusing a dose of the RP indicated for use into the patient, the Intego™ PET Infusion System measures the dose activity to ensure that the correct dosage will be infused.

  • Page 21: Shielded Chamber Components

    2 - System Basics Shielded Chamber Components INT SYS 200 INT SYS 100 SAS Track – Recessed path used to hold the SAS and to prevent it from being damaged as the Shielded Chamber Lid is opened or closed. Vial Shield Compartment – The chamber where the Vial Shield is placed. Needle Insertion Device –...

  • Page 22: System Components

    Medrad™ Intego™ PET Infusion System System Components INT SYS 200 INT SYS 100...
  • Page 23 PAS Compartment Cover – Hinged cover to access the PAS Compartment. On/Shutdown/Standby Button – Turns the Intego™ PET Infusion System On and Off. Also used to place the Intego™ PET Infusion System into and out of Standby. Also used to lock and unlock the system.

  • Page 24: Source Administration Set (Sas) Components

    Medrad™ Intego™ PET Infusion System Source Administration Set (SAS) Components Saline Spike – Inserted into the Saline Container. Saline Tube – Section of tube that is placed along the SAS Track and into the Saline Pump. RP Tube – Section of tube from the Needle Cartridge to the Confluence that is placed in the RP Pump.

  • Page 25: Patient Administration Set (Pas) Components

    2 - System Basics Patient Administration Set (PAS) Components PAS Tubing Removable Prime Tube – Captures excess saline during PAS priming. One-Way Check Valve – Connected to the patient catheter or needle. Prevents fluid backflow. Luer Connector – Connects the PAS to the SAS Swabbable Valve.

  • Page 26: Vial Shield Components

    Carrying Handle – Removable handle for transporting the Vial Shield and removing the Access Cap. NOTE: For more information regarding Vial Shields, refer to the "Appendix D - Vials and Vial Shields." Calibration Source Holder Calibration Source Holder – Used to insert calibration sources into the Intego™ PET Infusion System Dose Calibrator.

  • Page 27: Managing Power States

    Allow the Intego™ PET Infusion System to stabilize at room temperature before use. Plug the Intego™ PET Infusion System power cable into an AC outlet and move the Power Switch to the On position.

  • Page 28: Powering Off The System

    Dose Calibrator and the INT SYS 200 systems cannot be driven. NOTE: If the Intego™ PET Infusion System is in Standby and the power cable is not plugged into AC power within 30 minutes, the system will completely power Off.

  • Page 29: Securing The Intego™ Pet Infusion System

    To enable the Device Lock feature, see "System Configuration." Press the ON/SHUTDOWN/STANDBY button. A dialog box appears on the screen with the message “Intego Power and Security Options.” Press the LOCK button. A dialog box appears on the screen with the message...

  • Page 30: Unlocking The Device

    Medrad™ Intego™ PET Infusion System Unlocking the Device If the Intego™ PET Infusion System is powered Off or in Standby, press the ON/ SHUTDOWN/STANDBY button. In the “Device Locked” dialog box, enter the four digit security code and press the ENTER...

  • Page 31: Locking The Shielded Chamber

    2 - System Basics Locking the Shielded Chamber A standard lock can be inserted in the mechanism shown below, if locking the Shielded Chamber is desired. INT SYS 200 INT SYS 100...

  • Page 32: Navigating The User Interface

    Medrad™ Intego™ PET Infusion System Navigating the User This section provides an overview of the main screens the operator will use with the Intego™ Interface PET Infusion System. Screen Overview Title Bar – Located at the top of the screen. It identifies the current screen: System Preparation, Schedule, Dosing, or Configuration.

  • Page 33: System Preparation Screen

    2 - System Basics System Preparation Screen This screen enables the user to enter RP assay and saline information. The Multi-Dose Vial data, Saline Container remaining volume, activity in the SAS tubing, and the volume and activity contained in the Waste Container are monitored from the System Preparation screen. Daily QC and SAS priming are initiated from this screen.

  • Page 34: Dosing Screen

    Medrad™ Intego™ PET Infusion System Dosing Screen This screen enables the user to monitor the Multi-Dose Vial schedule, prepare and deliver the patient dose using Personalized Dosing or Manual Dosing, enter patient and operator data, prime the PAS, perform test injections, change the flow rate, and monitor the RP activity being delivered to the patient.

  • Page 35: Moving The Intego™ Pet Infusion System Int Sys 200

    60 minutes after which the system will go into Standby. NOTE: If the Intego™ PET Infusion System is in Standby and the power cable is not plugged into AC power within 30 minutes, the Intego™ PET Infusion System will completely Shutdown.

  • Page 36: Moving The System Using The Drive Override (For Emergency Use Only)

    AC outlet to charge the battery. Choose either slow or fast on the Drive Speed Switch. Firmly grip both of the handles on the Intego™ PET Infusion System at the Operator Position. Squeeze the Drive Engage Switch.

  • Page 37: Moving The Intego™ Pet Infusion System Int Sys 100

    Disengage the Caster Brakes. WARNING: Crush hazard. Using the Drive Override disengages the Drive System brakes. Ensure the Intego™ PET Infusion System is not on an incline or left unattended when using the Drive Override and re-engage the Drive Override after moving the system and engage the Caster Brakes.
  • Page 38 Standby. NOTE: If the Intego™ PET Infusion System is in Standby and the power cable is not plugged into AC power within 30 minutes, the system will completely power Off. Unplug the power cable from the AC outlet and wrap the power cable on the Cable Storage.

  • Page 39: System Configuration

    3 - System Configuration 3 - System Configuration To configure the Intego™ PET Infusion System, press the CONFIGURATION button on the Navigation Bar. NOTE: To save configuration changes, press the OK button. To return to the factory settings, press the DEFAULT button.
  • Page 40 Medrad™ Intego™ PET Infusion System Press the Date/Time tab to access the date and time configuration options. Configure the date format by pressing the Date Format field. Five date formats will be displayed. Press the button showing the desired date format.

  • Page 41: Dosing Settings

    3 - System Configuration Configure the weight units by pressing either the POUNDS button or the KILOGRAMS button. Configure the activity units by pressing either the CURIE button or the BECQUEREL button. Press the Audio tab to access the audio configuration options. Configure the audio level by pressing the HIGH button, NORMAL button, or LOW button.
  • Page 42 Configure the Intego™ PET Infusion System to use Personalized Dosing by default by pressing the Default Setting ON button. Configure the Intego™ PET Infusion System to use Manual Dosing by default by pressing the Default Setting OFF button. Up to five Personalized Dosing formulas can be entered by pressing the EDIT FORMULAS button.
  • Page 43 WARNING: Injury or death may result from injecting air. If an additional flush volume is used with extension tubing, the Intego™ PET Infusion System will not prime the additional tubing automatically. Air may be injected into the patient if the extension tubing is not primed before use.
  • Page 44 Medrad™ Intego™ PET Infusion System Press the Case tab to access the Case configuration options. Configure the Intego™ PET Infusion System by pressing the button with the desired default infusion site. NOTE: If a default infusion site is not configured, the user will be given the option to select the infusion site when entering patient information on the Dosing screen.

  • Page 45: Maintenance Settings

    3 - System Configuration Maintenance Settings On the left side of the Configuration screen, press the MAINTENANCE button to access the maintenance options. Daily QC, Linearity, Calibration, and Service tabs will be displayed along the top. Press the Daily QC tab to access the Daily QC configuration options. Press the Lot Number field and enter the lot number of the Cs calibration source to be used for Daily QC.
  • Page 46 Medrad™ Intego™ PET Infusion System Press the Service tab to access the service configuration options. To configure a MEDRAD Service reminder, press the Calendar icon next to the Reminder Date field and enter the desired date. To export log files, insert a USB memory device into the USB Port. Press either the 30 DAYS or ALL LOGS button, then remove the USB Memory device after the Intego™...

  • Page 47: Security Settings

    OFF button to disable the Device Lock feature. NOTE: Locking the device prevents unauthorized use or movement of the Intego™ PET Infusion System (for INT SYS 200 only) and requires a user to enter the default or a user-specific security code after powering On.
  • Page 48 Medrad™ Intego™ PET Infusion System Press the ENTER button. The OK button will appear. Press OK to accept the new code.

  • Page 49: Daily Setup

    AC outlet. WARNING: No modification of this equipment is allowed. WARNING: Do not use the Intego™ PET Infusion System in an oxygen rich environment (Environment in which the concentration of oxygen is greater than 25% for ambient pressures up to 110kpa).
  • Page 50 Medrad™ Intego™ PET Infusion System If the Intego™ PET Infusion System was in Training Mode, the system will display the message “Changing from Training Mode to Clinical Mode requires a restart. Continue?” Press OK to proceed. The Intego™ PET Infusion System will display a progress bar while switching to Clinical Mode.

  • Page 51: Using The Schedule

    Multi-Dose Vial schedule can either be entered manually or imported via the USB Port. The user may edit the schedule as it changes throughout the day. NOTE: The Intego™ PET Infusion System may highlight scheduled RP infusions. Refer to the "Vial Monitoring" section of this document for more information.

  • Page 52: Manually Entering Schedule Information

    Select third party nuclear medicine management software packages. Using a spreadsheet program or text editor. NOTE: Please contact MEDRAD for more information about creating an electronic schedule. Insert the USB memory device into the USB Port on the Display. Press the IMPORT SCHEDULE button. The time and activity information automatically...

  • Page 53: Editing The Schedule

    To edit a scheduled RP infusion, press the Time field or Activity field and enter the new value. NOTE: The Intego™ PET Infusion System automatically sorts the schedule by infusion time. Editing infusion time may reorder the schedule. To delete a scheduled infusion, press the X button.

  • Page 54: Exporting The Infusion History

    The Intego™ PET Infusion System creates an infusion history as each infusion is completed. The infusion history consists of a .csv file for each of the last 31 days the Intego™ PET Infusion System was used. To export the infusion history, insert a USB memory device in the USB Port and press the EXPORT HISTORY button.

  • Page 55: Performing Daily Qc

    Daily QC results, but this is not recommended. An Attention icon is displayed on the DAILY QC button when the system is being used without valid Daily QC results. WARNING: Using the Intego™ PET Infusion System without performing the necessary QC processes could result in the patient receiving an incorrect dosage of the RP indicated for use.
  • Page 56 Medrad™ Intego™ PET Infusion System Press the START button. The Intego™ PET Infusion System will automatically proceed with all listed Daily QC tests and check the box next to each test as it completes. NOTE: The Bias Adjustment may compensate for a failed Zero Adjustment. The Daily QC is valid if the Zero Adjustment fails but the Bias Adjustment is successful.
  • Page 57 4 - Daily Setup NOTE: When the Cs calibration source lot number is changed, the Constancy check will establish a new reference activity for future Constancy checks instead of testing Constancy against the previous reference. Grasp the Shielded Chamber Lid Latch to release it, and open the Shielded Chamber Lid to gain access to the Shielded Chamber.

  • Page 58: Entering Rp Assay And Saline Information

    Medrad™ Intego™ PET Infusion System 10. At the conclusion of the Daily QC, the Intego™ PET Infusion System displays a summary screen. Print this screen to keep with the system's records. 11. Press the SUMMARY button to return to the main System Preparation screen.
  • Page 59 NOTE: If the level of radioactivity in the Multi-Dose Vial exceeds 27.75 GBq (750 mCi), the Intego™ PET Infusion System displays the message “Vial activity exceeds safe shielding level. Immediately return vial to protective container.” If this message appears, remove the Vial Shield from the system and return to hot lab or other storage capable of providing adequate shielding for the contained activity.

  • Page 60: Installing The Sas

    Installing the SAS or installing the Multi-Dose Vial may be performed before or after entering RP Assay and Saline Information. NOTE: In the following steps, it will be helpful to refer to the diagrams of the Intego Infusion System Components, Intego Shielded Chamber Components, and the SAS Components.
  • Page 61 Chamber Lid as a work space while there are radioactive materials present within the Intego™ PET Infusion System. Using the Shielded Chamber Lid as a work space or placing items on the Shielded Chamber Lid while it is open may damage the Shielded Chamber Lid, hampering its ability to provide an adequate radiation shield.
  • Page 62 RP Pump on the side closest to the Vial Shield Compartment. Close the RP Pump door. CAUTION: Incorrect installation of the SAS may result in improper functioning of the Intego™ PET Infusion System. Insert the Confluence into the SAS Confluence Holder.
  • Page 63 4 - Daily Setup Insert the SAS Coil into the Dose Calibrator. Be sure the Pre-Coil Tube enters and the Post-Coil Tube exits on top of the SAS Coil and the SAS Coil is placed at the bottom of the Dose Calibrator.
  • Page 64 Medrad™ Intego™ PET Infusion System CAUTION: Incorrect installation of the SAS may result in improper functioning of the Intego™ PET Infusion System. 13. Firmly press the Patient Tube exiting the PAS Pinch Valve into the Air Detector Holder and Air Detector. Insert the Swabbable Valve into the Swabbable Valve Holder.
  • Page 65 CAUTION: Incorrect installation of the SAS may result in improper functioning of the Intego™ PET Infusion System. Ensure the Saline Disconnect Luer rests against the edge of the Saline Pump. CAUTION: Incorrect installation of the SAS may result in improper functioning of the Intego™...
  • Page 66 Medrad™ Intego™ PET Infusion System 16. Route the Saline Tube along the SAS Track, starting at the SAS Confluence Holder and moving towards the Saline Pump. Be sure to press the tubing firmly into the SAS Track. 17. Press the Saline Tube into the Saline Tube Holder between the Saline Pump and SAS Track.

  • Page 67: Installing The Multi-Dose Vial

    Multi-Dose Vial. Installing the SAS should be completed prior to installing the Multi-Dose Vial. NOTE: In the following steps, it will be helpful to refer to the diagrams of the Intego Infusion System Components, Intego Shielded Chamber Components, and the SAS Components.
  • Page 68 SAS Needles should be oriented over the Multi-Dose Vial septum. Press down on the Needle Insertion Device's handle until the Needle Insertion Device is in its original closed position as shown in the Intego Shielded Chamber Components diagram. The SAS Needles will penetrate the Multi-Dose Vial as the Needle Insertion Device is lowered.

  • Page 69: Installing The Pas

    CAUTION: Component damage may occur if not installed properly. Ensure all connections are secure. DO NOT over-tighten. NOTE: In the following steps, it will be helpful to refer to the diagrams of the Intego Infusion System Components, Intego Shielded Chamber Components, and the SAS Components.

  • Page 70: Priming The Sas

    Vial Shield at this point, allowing safe correction of SAS installation errors detected during this phase. Priming RP - The Intego™ PET Infusion System fills the SAS Needles and RP Tube with RP. WARNING. Radiation exposure hazard. Once RP priming commences RP is in the SAS and no longer contained within the Vial Shield.

  • Page 71: Patient Infusion

    Pre-populating patient information is a convenience feature to reduce the amount of hand-entry a user must perform. NOTE: The Intego™ PET Infusion System will prevent initiation of a patient infusion with less than three minutes remaining on the battery meter.
  • Page 72 Infusion Site button. Press OK when finished entering patient information. NOTE: The Intego™ PET Infusion System requires confirmation that the Patient Entry field has been reviewed, even if information was not entered. To proceed without entering information, press EDIT, then press OK.

  • Page 73: Priming The Pas

    The Intego™ PET Infusion System will prevent priming with less than three minutes remaining on the battery meter. When priming is complete, the Intego™ PET Infusion System will beep. Confirm that fluid is in the Removable Prime Tube and visually inspect the PAS for air.

  • Page 74: Selecting The Flow Rate

    WARNING: Injury to patient may occur if system is moved without disconnecting the PAS from the patient. Disconnect the PAS from the patient prior to moving the Intego™ PET Infusion System. Selecting the Flow Rate The FLOW RATE button displays the currently configured flow rate. If this flow rate is not the desired flow rate, press the button and select the desired flow rate from the displayed list.

  • Page 75: Performing A Saline Test Inject

    On the Dosing screen, press the TEST INJECT button. The Intego™ PET Infusion System displays a message asking the user to confirm that a check for air has been completed. Inspect the PAS Tubing for air.

  • Page 76: Entering The Requested Dose Activity

    Press the Requested Activity field and use the keypad to enter the activity value. The Intego™ PET Infusion System will only accept a value within the displayed Valid Range (the range of patient doses the system is capable of...

  • Page 77: Requested Activity And The Activity Bar

    Intego™ PET Infusion System. NOTE: The filled color portion covers the valid range of doses the Intego™ PET Infusion System can deliver under current conditions. NOTE:...

  • Page 78: Preparing An Rp Dose

    Press the PREPARE button to prepare the dose of RP to be infused. If a test injection was not already performed, the Intego™ PET Infusion System displays a message asking the user to confirm that the PAS has been inspected for air (see the "Performing Saline Test Inject"...

  • Page 79: Infusing Or Discarding The Dose

    To infuse the dose, press the INFUSE button. To discard the dose, press the DISCARD button. While infusing or discarding the dose, the Intego™ PET Infusion System displays a graph showing the percentage of the prepared dose activity remaining in the Dose Calibrator over the infusion or discard.

  • Page 80: Infusion Completion

    Infusion Completion After an infusion completes, the Intego™ PET Infusion System displays a summary screen that shows the amount of RP delivered (both volume and activity), total fluid volume delivered, and any patient information provided.

  • Page 81: Discard Completion

    PAS, then proceed with "Entering Patient Information." Discard Completion After a discard completes, the Intego™ PET Infusion System displays a summary screen that shows the RP activity delivered, RP activity discarded, and any patient information provided. To retry infusing the same patient, press the RETRY button. The main Dosing screen appears with the patient information panel visible on the right side.

  • Page 82: Monitoring The Vial

    "Entering Patient Information." Monitoring the Vial The Intego™ PET Infusion System continuously analyzes if the activity and volume of the currently loaded Multi-Dose Vial is sufficient to meet the dosing requirements of the Multi-Dose Vial schedule. When the Multi-Dose Vial schedule cannot be satisfied with the Multi-Dose Vial,...
  • Page 83 5 - Patient Infusion On the Schedule screen: By displaying an Attention icon and message in the Status Bar, by highlighting the unachievable RP infusions in yellow, and by displaying the valid dose range under the planned dose for the first unachievable RP infusions in the schedule. While the Multi-Dose Vial is intended to meet the original Multi-Dose Vial schedule, there are several reasons a schedule may become unachievable: •...
  • Page 84 Medrad™ Intego™ PET Infusion System...

  • Page 85: Vial Shield And Sas Removal

    SAS to control the needles. Dispose of the needles per individual facility guidelines. WARNING: Radiation exposure hazard. The Intego™ PET Infusion System may contain radioactive materials. Do not reach under cart while the system contains activity. Do not remove access panels while the system contains activity.
  • Page 86 Medrad™ Intego™ PET Infusion System WARNING. Puncture hazard. Do not attempt to recap needles. Remove the SAS Coil from the Dose Calibrator. 10. Using tongs, lift the Waste Container from the Waste Storage and remove the SAS from the Shielded Chamber.

  • Page 87: Training Mode

    7 - Training Mode 7 - Training Mode WARNING: Radiation exposure hazard. DO NOT install RP into the Intego™ PET Infusion System while in Training Mode. If the system detects radiation in the Dose Calibrator while operating in Training Mode, it will indicate an error and operation will stop.
  • Page 88 The screen displays the current mode in the lower right corner of the Introduction screen. If the Intego™ PET Infusion System was in Clinical Mode, the system will display the message “Changing from Clinical Mode to Training Mode requires a restart. Continue?”...
  • Page 89 7 - Training Mode The Intego™ PET Infusion System will display a progress bar while switching to Training Mode. When complete, the system will display a message prompting the user to restart. Press the RESTART button to Restart the system.
  • Page 90 Medrad™ Intego™ PET Infusion System...

  • Page 91: Appendix A - Cleaning And Maintenance

    Chamber Lid as a work space while there are radioactive materials present within the Intego™ PET Infusion System. Using the Shielded Chamber Lid as a work space or placing items on the Shielded Chamber Lid while it is open may damage the Shielded Chamber Lid, hampering its ability to provide an adequate radiation shield.

  • Page 92: Cleaning Guidelines

    Cleaning Guidelines CAUTION: DO NOT use strong cleaning agents and solvents. Warm water and a mild soap solution are all that are required to clean the Intego™ PET Infusion System. Allow all components to dry thoroughly before using. CAUTION: DO NOT soak or immerse any part of the Intego™ PET Infusion System or expose to excessive amounts of water or cleaning solutions while cleaning.

  • Page 93: Recommended Maintenance Schedule

    MEDRAD Service makes on-site consulting or consulting references available upon request. The Intego™ PET Infusion System must be properly maintained to ensure that it is meeting product requirements. The individual maintenance system and schedule depends upon how each system is used, the type of procedures performed, and the frequency of use. The following maintenance schedule is recommended for the system.

  • Page 94: Dose Calibrator Linearity Check

    The Linearity check proceeds until the F activity decays to 3.7 MBq (100 μCi). If required, this limit can be configured by MEDRAD to be as low as 370 kBq (10 μCi). NOTE: If the lower limit on the Linearity check is set to less than 3.7 MBq (100 μCi), the...
  • Page 95 Appendix A - Cleaning and Maintenance Press the CONFIGURATION button on the Navigation Bar to access the Configuration screen. The Configuration screen appears. Press the MAINTENANCE button and then press the Linearity tab.
  • Page 96 Press the NEW MEASUREMENT button to begin a new Linearity check. Enter the activity. NOTE: The Intego™ PET Infusion System automatically measures the activity level. If the clinician enters a value for activity, that value will be retained for future reference and reporting.
  • Page 97 Appendix A - Cleaning and Maintenance Press the BEGIN MEASUREMENT button. While the check is in progress, the Intego™ PET Infusion System provides a progress screen. To stop the Linearity check before it is complete, press the ABORT button. NOTE: During the Linearity check, the system displays the measured activity every 10 minutes.

  • Page 98: Dose Calibrator Calibration

    Medrad™ Intego™ PET Infusion System When the check is complete, the Intego™ PET Infusion System displays a summary screen (the screen shown is an example). Press the PRINT button for a hard copy of the results. Press the DONE button to exit.
  • Page 99 Appendix A - Cleaning and Maintenance NOTE: MEDRAD recommends that the calibration source is greater than 3.7 MBq (100 μCi) with a 3% source uncertainty. If a 3% or better source is not available, contact MEDRAD. Press the CONFIGURATION button on the Navigation Bar to access the Configuration screen.
  • Page 100 Medrad™ Intego™ PET Infusion System The Intego™ PET Infusion System displays a dialog box prompting the clinician to insert Co source into the Dose Calibrator. Using the Calibration Source Holder, insert the Co source into the Dose Calibrator and close the Shielded Chamber Lid.
  • Page 101 Co source. Press the Cs-137 tab. The Intego™ PET Infusion System then displays a dialog box prompting the user to insert Cs source into the Dose Calibrator. Using the Calibration Source Holder, insert the Cs source into the Dose Calibrator. Confirm the assay information listed for the second source is correct.

  • Page 102: Geometry Check

    Medrad™ Intego™ PET Infusion System 10. The Intego™ PET Infusion System measures the source and displays a status window for Cs source. Adjust the gain to achieve an error less than 1% by clicking in the GAIN field and entering the desired value using the keypad or by pressing the + and - buttons.

  • Page 103: Calibrating The Pinch Valves

    Appendix A - Cleaning and Maintenance Calibrating the Pinch Press the CONFIGURATION button on the Navigation Bar to access the Configuration Valves Screen. Press the MAINTENANCE button and then press the Calibration tab. Press the VALVE CALIBRATION button. The system displays a message prompting the user to remove all tubing from the Pinch Valves.

  • Page 104: Replacing The Printer Paper

    Medrad™ Intego™ PET Infusion System When the calibration procedure is complete the system will display a message that calibration is complete. Press OK. Replacing the Printer Depress the two locking catches on the sides of the printer (one on either side) and pull Paper the printer cover away from the cart.

  • Page 105: Battery Maintenance And System Storage

    Only drive the cart if the Drive System Status Indicator (Blue) is illuminated continuously. NOTE: If the Intego™ PET Infusion System will not be used and cannot be powered for more than 1 week, the user should contact MEDRAD to prepare the system for storage.

  • Page 106: Disposal Of Equipment

    Medrad™ Intego™ PET Infusion System Disposal of Equipment When the Intego™ PET Infusion System is at the end of its usable life cycle, certain precautions should be taken prior to the removal of the system. • Ensure that all calibration sources have been removed and properly stored.

  • Page 107: Appendix B - Specifications

    Appendix B - Specifications Appendix B - Specifications Mechanical INT SYS 200 13.66" (34.7 cm) 18.04" (45.8 cm) 51.44" (130.7 cm) 20.00" (50.8 cm) 37.49" (95.2 cm) Operator Position 38.46" 31.72" (97.7 cm) (80.6 cm) 27.24" (69.2 cm) 32.49" (82.5 cm)
  • Page 108 Medrad™ Intego™ PET Infusion System INT SYS 100 13.66" (34.7 cm) 25.55" (64.9 cm) 53.36" (135.5 cm) 23.66" (60.1 cm) 42.84" (108.8 cm) Operator Position 44.74" (113.6 cm) 33.64" (85.45 cm) 33.75" (85.72 cm) Nominal Value Notes Weight, INT SYS 200...

  • Page 109: Radiation Shielding Profile

    Appendix B - Specifications Radiation Shielding Vial Shield Radiation Profile Profile Exposure Rate at the surface with 27.75 GBq (750 mCi) in 30 ml saline in the vial. 0.26 mSv/hr (26 mrem/hr) 6.7 mSv/hr (672 mrem/hr) 2.3 mSv/hr (228 mrem/hr) Radiation Exposure Reduction Specification &...

  • Page 110: Environmental

    Medrad™ Intego™ PET Infusion System Environmental Nominal Value Notes Non-Operating Conditions Temperature, maximum ambient 60º C (140º F) Temperature, minimum ambient -20º C (-4º F) Humidity, maximum 100% R.H. Non-condensing Humidity, minimum 5% R.H. Non-condensing Pressure, maximum barometric 48 kPa (7 psi)

  • Page 111: Fluid Delivery

    Per IEC 60601-1, the Intego™ PET Infusion System is designated as a Class 1 medical device with a type BF applied part. Protection Against the Ingress of Fluids Per IEC 60529, the Intego™ PET Infusion System has been classified as drip proof. This is indicated by the IPX1 designation. Mode of Operation Per EN60601-1, the mode of operation for the Intego™...
  • Page 112 Medrad™ Intego™ PET Infusion System Nominal Value Notes Dose Activity Maximum dose activity 925 MBq (25 mCi) Maximum Dose Activity is reduced for RP concentrations ≤ 308 MBq/ml (8.3 mCi/ml). See Concentration-Based Dose limits graph. Minimum dose activity 37 MBq (1 mCi)

  • Page 113: Electromagnetic Compatibility (Emc)

    Compatibility (EMC) verified to conform to the requirements of 47CFR15 as a Class B digital device. EU: The Intego™ PET Infusion System has been verified to conform to the requirements of the Medical Device Directive (93/42/EEC). Mobility of INT SYS 200...

  • Page 114: Mobility Of Int Sys 100

    Medrad™ Intego™ PET Infusion System NOTE: Mobility battery recharge time is approximately 3x the discharge time. Users are advised to connect the Intego™ PET Infusion System to mains power whenever it is not moving. Mobility of INT SYS 100 Nominal Value...

  • Page 115: Appendix C - Troubleshooting Tips

    DO NOT open the Shielded Chamber without first taking radiation precautions per facility procedures. CAUTION: Incorrect installation of the SAS may result in improper functioning of the Intego™ PET Infusion System. • Ensure the Saline Container is sufficiently spiked.

  • Page 116: During An Infusion

    Medrad™ Intego™ PET Infusion System WARNING: Radiation exposure hazard. F-FDG or F-NaF emit gamma radiation. Operator should exercise extreme caution when handling radiopharmaceuticals. Doses may exceed maximum permissible dose if appropriate precautions are not properly exercised. Follow all individual facility guidelines for the handling and disposal of radioactive materials.

  • Page 117: With Rp In The Vial Shield

    If necessary, remove the SAS and the Multi-Dose Vial from the Shielded Chamber following the instructions found in the "Remove the Multi-dose Vial and SAS" section. Secure the Intego™ PET Infusion System and contact MEDRAD. With RP in the Vial Shield Restart the system.
  • Page 118 Medrad™ Intego™ PET Infusion System WARNING: Radiation exposure hazard. F-FDG or F-NaF emit gamma radiation. Operator should exercise extreme caution when handling radiopharmaceuticals. Doses may exceed maximum permissible dose if appropriate precautions are not properly exercised. Follow all individual facility guidelines for the handling and disposal of radioactive materials.

  • Page 119: Pas Occlusion Recovery

    At the end of the infusion, if more than 5% of the dose activity remains in the Dose Calibrator, the system will allow the user to resume the infusion or discard the dose. MEDRAD recommends that the user check the lines for occlusions (clamped tubing, kinked crushed tubing, or high-gauge needles or catheters, closed valves between the PAS and the patient) prior to resuming.
  • Page 120 Medrad™ Intego™ PET Infusion System If the user selects the DISCARD option or if activity remains in the Dose Calibrator after all attempts to resume, the remaining activity will be discarded into the Waste Container. The status bar will display any messages relating to the infusion.

  • Page 121: System Messages

    WARNING: In case of occlusion, do not disconnect disposables before discarding dose, as liquid leakage can occur. System Messages The following is a list of messages the Intego™ PET Infusion System could display and possible corrections: Critical Error Messages NOTE:...
  • Page 122 Medrad™ Intego™ PET Infusion System Assay information incomplete. Enter all required data. • Enter all required information. Source lot number, activity, and date/time are all required. Refer to "Daily QC" section in the Clinical Use chapter and "Dose Calibrator Calibration" section of this manual.
  • Page 123 • If the message reappears, restart the system. • If the message persists, record the error message and contact MEDRAD. Residual activity is higher than the acceptable • High residual activity remains from priming the SAS. background level. See Operation Manual.
  • Page 124 Medrad™ Intego™ PET Infusion System Source not detected. • During calibration, the source was not inserted into the Dose Calibrator. Insert the appropriate source to continue with calibration. Refer to the "Dose Calibrator Calibration" section of this manual. The date and time must be set.

  • Page 125: Appendix D - Vials And Vial Shields

    WARNING: Biological contamination may occur if aseptic techniques are not followed. Follow facility guidelines to disinfect the vial shield. WARNING: Radiation Exposure Hazard. The Intego™ PET Infusion System Vial Shields must be transported in a container that complies with applicable transportation regulations.
  • Page 126 Medrad™ Intego™ PET Infusion System NOTE: Table 1 represents the vials and compatible vial shields for use with the Medrad™ Intego™ PET Infusion System. For additional vials not specified in this table, please contact MEDRAD Service. Vial Shield and Vial Specifications - Summary...
  • Page 127 Appendix D - Vials and Vial Shields Table 2: Vial Shield and Vial Specifications - Silver Vial Shield Vial(s) Medrad Part Collar Weight Volume ISO 8362- Body Diameter Glass Height Number Color Range 1:2003 Diameter ISO 8362- 4:2003 Size Specification 3017469 8.6 kg...
  • Page 128 Appendix D - Vials and Vial Shields Table 3: Vial Shield and Vial Specifications - Blue Vial Shield Vial(s) Medrad Part Collar Weight Volume ISO 8362- Body Diameter Glass Height Number Color Range 1:2003 Diameter ISO 8362- 4:2003 Size Specification 3025071 8.6 kg...
  • Page 129 Appendix D - Vials and Vial Shields Table 4: Vial Shield and Vial Specifications - Gold Vial Shield Vial(s) Medrad Part Collar Weight Volume ISO 8362- Body Diameter Glass Height Number Color Range 1:2003 Diameter ISO 8362- 4:2003 Size Specification 3027139 8.6 kg...
  • Page 130 Appendix D - Vials and Vial Shields Table 5: Vial Shield and Vial Specifications - Green Vial Shield Vial(s) Medrad Part Collar Weight Volume ISO 8362- Body Diameter Glass Height Number Color Range 1:2003 Diameter ISO 8362- 4:2003 Size Specification 3025939 8.6 kg...
  • Page 131 Appendix D - Vials and Vial Shields Table 6: Vial Shield and Vial Specifications - Brown Vial Shield Vial(s) Medrad Part Collar Weight Volume ISO 8362- Body Diameter Glass Height Number Color Range 1:2003 Diameter ISO 8362- 4:2003 Size Specification 3025940 8.6 kg...
  • Page 132 Appendix D - Vials and Vial Shields Table 7: Vial Shield and Vial Specifications - Black Vial Shield Vial(s) Medrad Part Collar Weight Volume ISO 8362- Body Diameter Glass Height Number Color Range 1:2003 Diameter ISO 8362- 4:2003 Size Specification 25 ±...
  • Page 133 Appendix D - Vials and Vial Shields Table 8: Vial Shield and Vial Specifications - Violet Vial Shield Vial(s) Medrad Part Collar Weight Volume ISO 8362- Body Diameter Glass Height Number Color Range 1:2003 Diameter ISO 8362- 4:2003 Size Specification 21.25 ±...
  • Page 134 Appendix D - Vials and Vial Shields...

  • Page 135: Appendix E - Components And Catalog Numbers

    Appendix E - Components and Catalog Numbers Appendix E - Components and Catalog Numbers Catalog Number System Medrad™ Intego™ PET Infusion System INT SYS 200 or INT SYS 100 Accessories Power Cord - N. America 535-0243-012 Power Cord - International...
  • Page 136 Medrad™ Intego™ PET Infusion System Dutch (For INT SYS 100, use 3019945) 3031191 French (For INT SYS 100, use 3019946) 3031192 German (For INT SYS 100, use 3019944) 3031190 Italian (For INT SYS 100, use 3019949) 3031195 Spanish (For INT SYS 100, use 3019947)

  • Page 137: Index

    Index Index 16, 58, 75, 107 Access Cap 67, 68 Activity Bar Activity Remaining Graph 4, 9, 11, 54, 75, 105, 106, 111 Air Detector 11, 54 Air Detector Holder Battery Maintenance Brake Release 13, 25, 26, 27, 28 Cable Storage 84, 93 Calibrating the Pinch Valves Calibration...
  • Page 138 83, 84 Maintenance Schedule Maintenance Settings Mobility (INT SYS 100) Mobility (INT SYS 200) Moving the Intego™ PET Infusion System INT SYS 100 Moving the Intego™ PET Infusion System INT SYS 200 Multi-Dose Vial 48, 50, 57, 60, 113 Installation...
  • Page 139 Index Components 59, 60 Installation Occlusion Recovery 63, 65, 68 Priming Tubing 11, 13, 58, 59 PAS Compartment 13, 50, 57, 58, 59, 75 PAS Compartment Cover PAS Occlusion Recovery 11, 53, 54, 75, 106, 108 PAS Pinch Valve 65, 68 PAS Tubing 22, 34, 61, 62, 70, 71, 72 Patient Information...
  • Page 140 14, 53, 60, 76 SAS Coil 11, 52, 56 SAS Confluence Holder 11, 14, 56 SAS Track Securing the Intego™ PET Infusion System Locking the Device Locking the Shielded Chamber Unlocking the Device 20, 24, 37, 39 Security Code 5, 9, 10, 11, 13, 19, 21, 75...
  • Page 141 Index 9, 16, 48, 49, 58, 59, 60, 75, 76, 98, 99, 101, 107, 114, 126 Vial Shield 51, 52, 58, 59, 107 Vial Shield Compartment 10, 11, 14, 23, 25, 53, 60, 69, 76, 103, 110, 112, 114 Waste Container 11, 53, 75 Waste Pinch Valve 11, 53, 76...
  • Page 142 Medrad™ Intego™ PET Infusion System...

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