Medrad Intego Operation Manual
3031103 Rev. G
Operation Manual
English
Medrad™ Intego™ PET Infusion System
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.
Reproduction of this manual is strictly prohibited without express written consent of
MEDRAD, INC.
For more information about MEDRAD products and services, please visit www.medrad.com.
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Medrad™ Intego™
PET Infusion System
iiii
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 ....................................................................................................................... 1
Required Training ............................................................................................................. 1
Contact Information .......................................................................................................... 2
Definitions ......................................................................................................................... 2
Symbols and Icons ........................................................................................................... 2
Product Symbols ....................................................................................................... 2
Warnings ................................................................................................................... 4
Display Icons ............................................................................................................ 5
Status Indicators ....................................................................................................... 6
Packaging ................................................................................................................. 7
2 - System Basics ...........................................................................................9
System Overview .............................................................................................................. 9
Safety Features .............................................................................................................. 10
Shielded Chamber Components ..................................................................................... 11
System Components ...................................................................................................... 12
Source Administration Set (SAS) Components .............................................................. 14
Patient Administration Set (PAS) Components .............................................................. 15
Vial Shield Components ................................................................................................. 16
Calibration Source Holder ............................................................................................... 16
Managing Power States .................................................................................................. 17
Powering On the System ........................................................................................ 17
Powering Off the System ........................................................................................ 18
Placing the System into Standby ............................................................................ 18
Taking the System out of Standby .......................................................................... 18
Securing the Intego™ PET Infusion System .................................................................. 19
Locking the Device ................................................................................................. 19
Unlocking the Device .............................................................................................. 20
Locking the Shielded Chamber ............................................................................... 21
Navigating the User Interface ......................................................................................... 22
Screen Overview .................................................................................................... 22
System Preparation Screen .................................................................................... 23
Schedule Screen .................................................................................................... 23
Dosing Screen ........................................................................................................ 24
Configuration Screen .............................................................................................. 24
Moving the Intego™ PET Infusion System INT SYS 200 ............................................... 25
Moving the System Using the Drive Override (For Emergency Use Only) ............. 26
Moving the Intego™ PET Infusion System INT SYS 100 ............................................... 27
3 - System Configuration .............................................................................29
System Settings .............................................................................................................. 29
Dosing Settings ............................................................................................................... 31
Maintenance Settings ..................................................................................................... 35
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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 ............................................................................................... 43
Exporting the Infusion History ................................................................................. 44
Performing Daily QC ....................................................................................................... 45
Entering RP Assay and Saline Information ..................................................................... 48
Installing the SAS ........................................................................................................... 50
Installing the Multi-Dose Vial .......................................................................................... 57
Installing the PAS ........................................................................................................... 59
Priming the SAS ............................................................................................................. 60
5 - Patient Infusion .......................................................................................61
Entering Patient Information ........................................................................................... 61
Priming the PAS ............................................................................................................. 63
Selecting the Flow Rate .................................................................................................. 64
Performing a Saline Test Inject ....................................................................................... 65
Entering the Requested Dose Activity ............................................................................ 66
Personalized Dose Entry ........................................................................................ 66
Manual Dose Entry ................................................................................................. 66
Requested Activity and the Activity Bar .................................................................. 67
Preparing an RP Dose .................................................................................................... 68
Infusing or Discarding the Dose ...................................................................................... 69
Start and Monitor Infusion ....................................................................................... 69
Infusion Completion ................................................................................................ 70
Discard Completion ................................................................................................ 71
Monitoring the Vial .......................................................................................................... 72
6 - Vial Shield and SAS Removal ................................................................75
7 - Training Mode ......................................................................................... 77
Appendix A - Cleaning and Maintenance ...................................................81
Cleaning Guidelines ........................................................................................................ 82
Recommended Maintenance Schedule .......................................................................... 83
Dose Calibrator Linearity Check ..................................................................................... 84
Dose Calibrator Calibration ............................................................................................. 88
Geometry Check ............................................................................................................. 92
Calibrating the Pinch Valves ........................................................................................... 93
Replacing the Printer Paper ............................................................................................ 94
Battery Maintenance and System Storage ..................................................................... 95
Disposal of Equipment .................................................................................................... 96
Appendix B - Specifications ........................................................................ 97
Mechanical ...................................................................................................................... 97
Radiation Shielding Profile .............................................................................................. 99
Environmental ............................................................................................................... 100
Electrical ....................................................................................................................... 100
Fluid Delivery ................................................................................................................ 101
Electromagnetic Compatibility (EMC) ........................................................................... 103
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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 .................................................................................... 105
During an Infusion ................................................................................................. 106
Recovering a Dose Due to a System Failure ................................................................ 106
With a Dose of RP in the Dose Calibrator ............................................................ 106
With RP in the Vial Shield ..................................................................................... 107
PAS Occlusion Recovery .............................................................................................. 109
System Messages ........................................................................................................ 111
Critical Error Messages ........................................................................................ 111
Recoverable Errors / Messages ........................................................................... 111
Appendix D - Vials and Vial Shields .........................................................115
Appendix E - Components and Catalog Numbers ..................................125
Index ............................................................................................................127
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Medrad™ Intego™ PET Infusion System
vivi
English
Important Safety Notice to Users of the
Medrad™ Intego™ PET Infusion System
This manual and the equipment it describes are for use only by qualified medical professionals
with training and experience in Nuclear Medicine procedures. It is intended as a guide for using
both the Intego™ PET Infusion System and dedicated Intego™ PET Infusion System
disposables.
The Intego™ PET Infusion System contains a gross air detection feature, which is intended to
assist qualified medical professional users/operators during the set up procedure to ensure
that all air is out of the 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. It is important that the operating
instructions and user warnings supplied with the Intego™ PET Infusion System be read,
understood, and followed.
Before starting any PET infusion procedure, the device user should be trained in the particular
procedures to be performed and should be familiar with the medical literature related to
procedures and the potential complications and risks verses the benefits of utilizing
radiopharmaceutical fluid infusion procedures.
This manual is intended as an extension of the user interface of the Intego™ PET Infusion
System to provide procedural and technical information. Additional Intego training information
is available in the following formats:
• On-Site in-service sessions
• Service manual
• Package inserts (IFU)
Please do not hesitate to contact MEDRAD if any of these resources are needed.
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Medrad™ Intego™
PET Infusion System
viiiviii
1 - Introduction
1 - Introduction
Certifications The Intego™ PET Infusion System is equipped to operate at 100-240 VAC, 50/60Hz. Power
consumption is 250 VA for the INT SYS 100 and 300 VA for the INT SYS 200. The INT SYS
100 complies with EN/IEC 60601-1, 2nd Edition. The INT SYS 200 complies with EN/IEC
60601-1, 2nd and 3rd Editions.
Intended Use The Intego™ PET Infusion System is intended to deliver accurate doses of
18
Fluorodeoxyglucose (
commonly used flushing solutions to patients during molecular imaging (nuclear medicine)
diagnostic procedures. The Intego™ PET Infusion System is also intended to provide effective
radiation shielding to medical personnel from Fluorine-18 (
nuclear medicine diagnostic procedures.
F-FDG) or 18F-Sodium Fluoride (18F-NaF) radiopharmaceuticals and
18
F) radiation exposure during
Indications for Use The Intego™ PET Infusion System is indicated for the administration of
commonly used flushing solutions to patients during molecular imaging (nuclear medicine)
procedures.
NOTE: The Intego™ PET Infusion System is intended for use with
Intego™ PET Infusion System disposables intended for use with
18
be used to deliver
information.
F-FDG or 18F-NaF. Please contact MEDRAD for more
18
F-
18
F-FDG, 18F-NaF, and
18
F-FDG or 18F-NaF.
18
F-FDG may
Restricted Sale The United States Food and Drug Administration (FDA) restricts sale of this system to
physicians or those with written authorization from a physician.
Trademarks MEDRAD and Intego are trademarks of MEDRAD, INC. Unless otherwise indicated, all
trademarks are owned by MEDRAD, INC. Other trademarks that appear in this manual are the
property of their respective companies.
Disclaimers External wiring and modifications disclaimers: MEDRAD disclaims liability for any modifications
or interfaces with other equipment that are not in conformity with the specifications and
information contained within this manual.
Accessory equipment connected to the Intego™ PET Infusion System must be certified
according to IEC 60601-1 standard. Furthermore, all configurations shall comply with system
standard IEC 60601-1-1. Anyone who connects additional equipment to the signal input or
output port configures a medical system and is therefore responsible to ensure that the
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™ PET Infusion System in a safe manner.
Required Training This device is intended to be used by individuals with training and experience in nuclear
imaging studies.
1
Medrad™ Intego™ PET Infusion System
IPX1
Contact Information The following is MEDRAD’s contact information:
MEDRAD, INC.
One Medrad Drive
Indianola, PA 15051
USA
Phone: 412-767-2400
Fax: 412-767-4120
Imaxeon Pty. Ltd.
Rydalmere Metro Centre
Unit 1, 38-46 South Street
Rydalmere, Sydney NSW 2116
Australia
Phone: +61 2 8845 4999
Fax: +61 2 8845 4998
MEDRAD Europe B.V.
P.O. Box 20 5
6190 AE Beek
The Netherlands
Phone: +31(0)43-3585600
Fax: +31(0)43-3656598
MEDRAD Asia Pte. Ltd.
Blk 5000 Ang Mo Kio Ave 5
#05-08 Techplace II
Singapore 569870
Phone: +65 67525318
Fax: +65 67525807
Definitions The following are definitions of the terms WARNING, CAUTION, and NOTE found throughout
this document.
WARNING Indicates that the information is a warning. Warnings advise of
circumstances that could result in injury or death to the patient or
operator. Read and understand the warnings before operating the
Intego™ PET Infusion System.
CAUTION Indicates that the information is a caution. Cautions advise of
circumstances that could result in damage to the system or
improper functioning of the system. Read and understand the
cautions before operating the Intego™ PET Infusion System.
NOTE Indicates that the information that follows is additional important
information, a tip that helps the clinician to recover from an error, or
points to related information within the manual.
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.
Product Symbols
Indicates that this system conforms to requirements of the European Medical Device Directive 93/42/EEC.
Indicates that this system conforms to CSA requirements.
IPX1 Code that specifies the degree of protection against vertically
falling water drops (IEC 60529).
2
1 - Introduction
CLASS 1
Indicates separate collection for electrical and electronic equipment per directive 2002/96/EEC.
The Intego™ PET Infusion System is a Class 1 electrical device as
determined by IEC 60601-1.
Radiopharmaceutical (
Stop button.
On/Shutdown/Standby button.
Applied parts rating. The infusion system is a BF applied part
device as determined by IEC 60601-1, indicating the degree of
protection against electric shock.
Fuse rating. See Intego address label for specific fuse rating information.
This symbol informs the user of the correct manner of use.
This symbol informs the user of the incorrect manner of use.
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F-FDG or 18F-NaF).
Label showing the correct and incorrect routing of the Source
Administration Sets (SAS) through the Saline Pump.
Label showing the correct and incorrect insertion of the Saline
Spike into the Saline Container.
Label showing the correct and incorrect routing of the tubing
through the RP Pump.
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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 TConnector and the tubing in each of the Pinch Valves.
Label showing the correct and incorrect method of inserting the
tubing into a Pinch Valve.
The following Product Symbols apply only to INT SYS 200 systems.
Indicates Drive Speed Switch is in fast speed range position.
Indicates Drive Speed Switch is in slow speed range position.
The following Product Symbol applies only to INT SYS 100 systems.
Brake release triggers.
Warnings
Attention symbols used to identify warnings and cautions in
product labeling.
Pinch hazard. This symbol indicates there is the potential for pinch
injury.
Crush hazard. This symbol indicates there is the potential for
crush injury.
4
1 - Introduction
1000mL
See accompanying documentation. This symbol indicates the user
should refer to the instructions-for-use to ensure safe operation.
Hazardous voltage. This symbol indicates there is a potential for
electrical shock injury.
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.
Sitting on the unit is prohibited.
Display Icons
Radiation activity icon
• Not highlighted in yellow – Radioactivity may or may not be
present within the Intego™ PET Infusion System.
• Highlighted in yellow – Radioactivity is present within the
Dose Calibrator and assay information has been entered into
the Intego™ PET Infusion System.
Fluid delivery battery status icon
• Not highlighted in yellow – Battery not present or battery is
completely depleted.
• Highlighted in yellow – Unit is operating on battery power.
Plug icon
• Battery is present but the unit is operating on AC Power/
Charging.
Fluid icon
• If present, fluid is currently being pumped within the Intego™
PET Infusion System.
Calendar icon. Touch this icon to enter the desired date.
5
Medrad™ Intego™ PET Infusion System
AM
PM
Day selector icon. Toggles between today and yesterday.
Configuration icon. Located on the configuration button; used to
open the Configuration screen.
Reset icon. Located on the reset button. Resets the RP field to the
configured default value or the current scheduled dose and resets
the patient infusion process back to entering patient information.
AM/PM icon. Press this icon to set AM or PM when entering time
data.
Approximately icon. Used to identify estimated values.
Attention icon. Used to identify items that require clinician
attention.
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.
Blinking – Intego™ PET Infusion System is On and Dose
Calibrator is warming up.
Off – Intego™ PET Infusion System is Shutdown.
Fluid Delivery Battery Backup Status (Amber)
On – Intego™ PET Infusion System is using battery backup.
Blinking – Only 5 minutes or less remain on battery before the
Intego™ PET Infusion System will completely Shutdown. Connect
the Intego™ PET Infusion System to AC power.
Off – Intego™ PET Infusion System is not using battery backup.
6
The following Status Indicators apply only to the INT SYS 200 systems.
REF
Drive System Status (Blue)
On – Drive System is available for use.
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.
System Battery Charging Status (Violet)
On – Batteries are charging.
Off – Batteries are not charging.
Packaging
1 - Introduction
Catalog Number.
Consult instructions for use.
Single use only.
For use with one vial of media only.
Do not use if package is opened or damaged.
Lot number.
Date of manufacture/sterilization.
Non-pyrogenic fluid path.
Fluid path sterilized using gamma radiation.
7
Medrad™ Intego™ PET Infusion System
100% RH
5% RH
%
-20 C
o
+60 C
o
Fluid path sterilized with Ethylene Oxide.
Use by date.
Atmospheric pressure range.
Humidity range.
Temperature range.
Contains DEHP.
Do not stack.
This side up.
Keep dry.
Fragile.
8
2 - System Basics
2 - System Basics
System Overview The Intego™ PET Infusion System delivers
PET/CT diagnostic procedure. In addition, the system provides effective radiation shielding to
18
medical personnel from
The Intego™ PET Infusion System meets the following clinical needs:
1. For a typical 555 MBq (15 mCi) infusion per patient, it limits
medical personnel to less than 60 μSv (6 mRem) finger dose and 3 μSv (0.3 mRem)
whole body dose.
2. Flexibility to program the required dose either by activity only or by activity per patient
weight.
3. Ability to deliver
measured dose, excluding Dose Calibrator calibration factor.
4. 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. A SAS is installed within the Shielded
Chamber at the same time a new Multi-Dose Vial of the RP indicated for use is installed. Just
prior to an infusion, the system measures a dose of RP along with a saline flush in the Dose
Calibrator. Once the correct radiation level is achieved, the RP dose and saline are infused into
the patient via a PAS. Rechargeable batteries provide sufficient power to keep the Dose
Calibrator warm so that the system can be unplugged and moved to a new location without
having to completely power Off.
F radiation exposure during nuclear medicine diagnostic procedures.
18
F-RP within ±10% of the prescribed dose and within ±2% of the
18
F-FDG or 18F-NaF to patients during a PET or
18
F radiation exposure for
The Intego™ PET Infusion System consists of the following:
1. RP Pump
2. Saline Pump
3. Dose Calibrator
4. Air Detector
5. System Shielding
6. Vial Shielding
NOTE: Radiation shielding performance is achieved by using the Vial Shield designed
by MEDRAD (or its equivalent).
9
Medrad™ Intego™ PET Infusion System
Safety Features The Intego™ PET Infusion System incorporates the following safety features to help protect
patients and operators while the system is in use.
NOTE: These features are intended to augment the safety program of a site.
• The RP is stored in a Shielded Chamber within the Intego™ PET Infusion System. A
patient's dose of the RP indicated for use is created automatically while the dose remains
within the Shielded Chamber, greatly reducing the operator's exposure to radiation. Any
waste material left over after an infusion remains within the Shielded Chamber until time
for disposal. By employing a SAS, which is also contained within the Shielded Chamber, it
is not necessary to replace the tubing set directly connected to the 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.
• The Intego™ PET Infusion System contains a Waste Container within the Shielded
Chamber. If it is necessary to discard a dose of RP, the dose is transferred into this Waste
Container to help prevent radiation exposure to the patient or operator.
• The Shielded Chamber Lid is secured by a heavy-duty latching system, which reduces the
likelihood of unintentionally opening the Shielded Chamber while radioactivity is contained
within. In addition, the Shielded Chamber Lid can be locked to prevent unauthorized
access to the Shielded Chamber.
•The Intego™ PET Infusion System Display can be locked to prevent unauthorized access
to the operating system.
• The Intego™ PET Infusion System has a saline test inject feature that may be used to
check vein patency prior to an infusion.
• The Intego™ PET Infusion System features an air detection system that automatically
disarms the Intego™ PET Infusion System if air is detected in the SAS.
• The Intego™ PET Infusion System PAS features a one-way check valve that prevents
backflow of fluids into the SAS.
The following is available only on INT SYS 200 systems.
• The Intego™ PET Infusion System is intended for use with a powered Drive System.
When the Drive System is being used, the system prevents test inject and dose delivery to
the patient.
The following is available only on INT SYS 100 systems.
• The Intego™ PET Infusion System employs a hydraulic braking system that is continually
engaged. The operator must continuously release the brakes to move the system.
10
Shielded Chamber
INT SYS 100
INT SYS 200
Components
2 - System Basics
1. 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.
2. Vial Shield Compartment – The chamber where the Vial Shield is placed.
3. Needle Insertion Device – A tungsten shielded lid with a fold-down handle that holds the
SAS Needle Cartridge.
4. RP Pump – Precision pump used for RP dose preparation.
5. SAS Confluence Holder – Secures the SAS Confluence in the correct location and
orientation.
6. T-Connector Holder – Secures the SAS T-Connector in the correct location and
orientation.
7. Dose Calibrator
8. Waste Pinch Valve – Controls fluid flow to the Waste Container.
9. PAS Pinch Valve – Controls fluid flow to the PAS.
10. Waste Storage – The area where the SAS Waste Container is placed.
11. Air Detector – Used to detect air in the fluid as it passes from the SAS into the PAS.
12. Air Detector Holder – Secures the SAS within the Air Detector.
13. Swabbable Valve Holder – Secures the Swabbable Valve in the correct location for
joining the PAS and SAS together.
14. Saline Tube Holder – Holds the Saline Tube in the PAS Compartment.
11
Medrad™ Intego™ PET Infusion System
INT SYS 100
System Components INT SYS 200
12
2 - System Basics
1. Display – Color touch screen display used to control the Intego™ PET Infusion System,
view delivery data, and report radioactivity within the system.
2. USB Port – Provides the operator the capability of importing and exporting data.
3. Shielded Chamber – Lead shielded compartment that houses the SAS, RP, and various
other system components.
4. Shielded Chamber Lid – A sliding lid that allows access to the components and RP
contained in the Shielded Chamber.
5. Shielded Chamber Lid Latch – Used to secure the Shielded Chamber Lid from
unintentional opening.
6. PAS Compartment – not shown – A separate compartment of the Shielded Chamber.
Provides shielding for the PAS (located under the PAS Compartment Cover).
7. PAS Compartment Cover – Hinged cover to access the PAS Compartment.
8. 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.
9. Stop Button – Used to stop current operation of the Intego™ PET Infusion System.
10. Power Switch – Rocker switch used to turn AC power On or Off.
11. Saline Pump – Peristaltic pump used to circulate saline in the SAS.
12. Saline Hook – Used for hanging the Saline Container.
13. Printer – Used to print patient-specific infusion records.
14. Cable Storage – Posts used for wrapping the power cable when the Intego™ PET
Infusion System is being moved or when not in use.
15. Caster Brakes – Used to secure the Intego™ PET Infusion System from movement when
parked.
The following apply only to INT SYS 200 systems.
16. Drive Controller – Thumb wheel to control forward/reverse variable speed.
17. Drive Engage Switch – Used to enable the Drive System.
18. Drive Speed Switch – Used to select the speed range of forward movement.
19. Drive Override – Mechanism to override the Drive System.
20. Status Indicators – Provides battery, Dose Calibrator, and Drive System status.
The following apply only to INT SYS 100 systems.
21. Brake Release – Located on each handle, used to release the primary brakes.
22. Status Indicators – Provides battery and Dose Calibrator status.
13
Source Administration
Set (SAS) Components
Medrad™ Intego™ PET Infusion System
1. Saline Spike – Inserted into the Saline Container.
2. Saline Tube – Section of tube that is placed along the SAS Track and into the Saline
Pump.
3. RP Tube – Section of tube from the Needle Cartridge to the Confluence that is placed in
the RP Pump.
4. Needle Cartridge – Contains the needles used to draw the RP into the SAS.
5. SAS Coil – Inserted into the Dose Calibrator. It holds the RP dose being measured by the
Dose Calibrator.
6. Pre-Coil Tube – Section of tube from the Confluence to the SAS Coil.
7. Post-Coil Tube – Section of tube from the SAS Coil to the T-Connector.
8. Waste Container – Collects any discarded fluid.
9. T-Connector – Union of Waste Tube, Patient Tube, and the Post-Coil Tube.
10. Waste Tube – Section of tube from the T-Connector to the Waste Container.
11. Patient Tube – Section of tube from the T-Connector to the Swabbable Valve.
12. Swabbable Valve – Enables aseptic connection between the SAS and PAS.
13. Saline Disconnect Luer – Disconnects the Saline Tube from the Saline Container.
14. Confluence – Union of RP Tube, Saline Tube, and Pre-Coil Tube.
14
Patient Administration
Set (PAS) Components
2 - System Basics
1. PAS Tubing
2. Removable Prime Tube – Captures excess saline during PAS priming.
3. One-Way Check Valve – Connected to the patient catheter or needle. Prevents fluid
backflow.
4. Luer Connector – Connects the PAS to the SAS Swabbable Valve.
15
Vial Shield Components
1
2
3
4
Medrad™ Intego™ PET Infusion System
1. Vial Shield – Multi-Dose Vial radiation shielding vessel designed to work specifically with
the Intego™ PET Infusion System.
2. Vial Cap – Removable cap that provides access to the RP vial.
3. Access Cap – Removable cap that provides access to the RP vial septum.
4. Carrying Handle – Removable handle for transporting the Vial Shield and removing the
Access Cap.
Calibration Source
Holder
NOTE: For more information regarding Vial Shields, refer to the "Appendix D - Vials and
Vial Shields."
Calibration Source Holder – Used to insert calibration sources into the Intego™ PET Infusion
System Dose Calibrator.
16
Managing Power States Powering On the System
WARNING: To avoid risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
CAUTION: DO NOT use the Intego™ PET Infusion System immediately after it
has been brought indoors from extreme outside temperatures. Condensation
may cause electrical damage to the system. Allow the Intego™ PET Infusion System
to stabilize at room temperature before use.
1. Plug the Intego™ PET Infusion System power cable into an AC outlet and move the
Power Switch to the On position.
2. Press and hold the ON/SHUTDOWN/STANDBY button until a beep sounds. The
Introduction screen will appear.
2 - System Basics
17
Medrad™ Intego™ PET Infusion System
Powering Off the System
1. Press the ON/SHUTDOWN/STANDBY button.
2. A dialog box appears on the screen with the message “Intego Power and Security
Options.” Press the SHUTDOWN button.
NOTE: If the Display is not functional, the ON/SHUTDOWN/STANDBY button can be
pressed and held for 15 seconds to power Off the Intego™ PET Infusion
System.
Placing the System into Standby
1. Press the ON/SHUTDOWN/STANDBY button.
2. A dialog box appears on the screen with the message “Intego Power and Security
Options.” Press the STANDBY button.
NOTE: Placing the system into Standby eliminates the need to wait for the Dose
Calibrator to warm up and allows the system to be driven (INT SYS 200 only). If
the system is Shutdown, the user will need to wait up to 15 minutes to use the
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.
NOTE: If the power cable is removed from an AC outlet, the Display will remain
powered for 60 minutes. After 60 minutes, the system will automatically go into
Standby.
Taking the System out of Standby
1. Press the ON/SHUTDOWN/STANDBY button to activate the Intego™ PET Infusion
System.
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2 - System Basics
Securing the Intego™
PET Infusion
System
The Device Lock feature secures the display and disables the Drive System (for INT SYS 200
only). A Standard lock can be used to secure the Shielded Chamber.
Locking the Device
NOTE: To enable the Device Lock feature, see "System Configuration."
1. Press the ON/SHUTDOWN/STANDBY button.
2. 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
“Device Locked.”
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Medrad™ Intego™ PET Infusion System
Unlocking the Device
1. If the Intego™ PET Infusion System is powered Off or in Standby, press the ON/
SHUTDOWN/STANDBY button.
2. In the “Device Locked” dialog box, enter the four digit security code and press the ENTER
button
NOTE: The factory set Security Code is 7237. It can be used to override any user
configured code.
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