Medrad Intego User manual

3031103 Rev. G
Operation Manual


ii
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.
English

iiii
Medrad™ Intego™ PET Infusion System

iiiiii
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

Medrad™ Intego™ PET Infusion System
iviv
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

vv
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

Medrad™ Intego™ PET Infusion System
vivi

viivii
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.
English

viiiviii
Medrad™ Intego™ PET Infusion System

1
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 18F-
Fluorodeoxyglucose (18F-FDG) or 18F-Sodium Fluoride (18F-NaF) radiopharmaceuticals and
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 (18F) radiation exposure during
nuclear medicine diagnostic procedures.
Indications for Use The Intego™ PET Infusion System is indicated for the administration of 18F-FDG, 18F-NaF, and
commonly used flushing solutions to patients during molecular imaging (nuclear medicine)
procedures.
NOTE: The Intego™ PET Infusion System is intended for use with 18F-FDG or 18F-NaF.
Intego™ PET Infusion System disposables intended for use with 18F-FDG may
be used to deliver 18F-FDG or 18F-NaF. Please contact MEDRAD for more
information.
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.

Medrad™ Intego™ PET Infusion System
2
Contact Information The following is MEDRAD’s contact information:
Definitions The following are definitions of the terms WARNING, CAUTION, and NOTE found throughout
this document.
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.
MEDRAD, INC.
One Medrad Drive
Indianola, PA 15051
USA
Phone: 412-767-2400
Fax: 412-767-4120
MEDRAD Europe B.V.
P.O. Box 205
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
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
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.
Product Symbols
Indicates that this system conforms to requirements of the Euro-
pean 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).
IPX1

3
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
determined by IEC 60601-1.
Radiopharmaceutical (18F-FDG or 18F-NaF).
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 infor-
mation.
This symbol informs the user of the correct manner of use.
This symbol informs the user of the incorrect manner of use.
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.
CLASS 1

Medrad™ Intego™ PET Infusion System
4
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.
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.

5
1 - Introduction
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.
1000mL

Medrad™ Intego™ PET Infusion System
6
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.
AM
PM

7
1 - Introduction
The following Status Indicators apply only to the INT SYS 200 systems.
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
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.
REF

Medrad™ Intego™ PET Infusion System
8
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.
100% RH
5% RH
%
-20 C
o
+60 C
o

9
2 - System Basics
2 - System Basics
System Overview The Intego™ PET Infusion System delivers 18F-FDG or 18F-NaF to patients during a PET or
PET/CT diagnostic procedure. In addition, the system provides effective radiation shielding to
medical personnel from 18F radiation exposure during nuclear medicine diagnostic procedures.
The Intego™ PET Infusion System meets the following clinical needs:
1. For a typical 555 MBq (15 mCi) infusion per patient, it limits 18F radiation exposure for
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 18F-RP within ±10% of the prescribed dose and within ±2% of the
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.
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).

10
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.
•TheIntego™ 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.
Table of contents
Other Medrad Medical Equipment manuals

Medrad
Medrad Avanta User manual

Medrad
Medrad MRXPERION User manual

Medrad
Medrad ProVis Mark V User manual

Medrad
Medrad AngioJet Ultra User manual

Medrad
Medrad Mark 7 Arterion User manual

Medrad
Medrad Spectris Solaris EP User manual

Medrad
Medrad Mark 7 Arterion User manual

Medrad
Medrad Stellant D Instruction Manual

Medrad
Medrad Spectris Solaris EP User manual