Bayer HealthCare MEDRAD Stellant Specification sheet

CT Injection System
CT Injection System
Operation and Installation Manual
MEDRAD® Stellant Imaging System Interface (ISI)
700 Module

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MEDRAD®Stellant Imaging System
Interface (ISI) 700 Module
Operation and Installation Manual
Operating specifications, options, accessories, and feature availability may
vary by country. Check with your local product representative and country-
specific operating instructions.
The MEDRAD®Stellant Imaging System Interface (ISI) 700 module has an
expected service life* of 7 years from the date of product installation when
operated according to the instructions provided with this device. These 7 years
include suggested or mandatory actions of preventative maintenance and
repair activities, as well as required calibration(s) that are needed. Required
reading includes the instructions for use and other materials provided with the
device. This also includes any hardware and software updates that may be
required.
* Expected Service Life: The length of time that an individual unit, lot, or batch
of devices is expected to remain functional after it is placed into use.
Report any serious incident that has occurred in relation to this device to Bayer
(radiology.bayer.com/contact) and to your local European competent authority
(or, where applicable, to the appropriate regulatory authority of the country in
which the incident has occurred).
A glossary of the symbols used on the MEDRAD®Stellant Imaging System
Interface (ISI) 700 Module can be found in Section 1 of this manual.
English

MEDRAD®Stellant ISI 700 Module Operation and Installation Manual
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Table Of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Certifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Restricted Sale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Disclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Operational Checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Overview of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Injector Head Indicator Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Details of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Hold and Test Inject features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Scan Delay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
ISI Module Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Power Cable Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
ISI Module System Messages and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Appendix A - Compliance to IEC 60601-1-2 / 2nd, 3rd, and 4th Editions . . . . . . . . . . . . . . . . . . . . 17
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

MEDRAD®Stellant ISI 700 Module Operation and Installation Manual
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Introduction The MEDRAD®Stellant Imaging System Interface (ISI) 700 Module (Catalog Number: ISI 700)
is an option that allows an injector from Bayer to interface with a CT scanner. It obtains its
power from a hospital grade wall outlet. It interacts with an injector and scanner through direct
cable connection. Once the ISI module is installed and configured on the injector, it allows the
scanner and injector to interact with each other and provide functionality as outlined in this
manual.
Read all the information contained in this manual. Understanding this information will assist
you in operating the ISI module option in a safe manner.
Installation Contact Bayer for Installation information.
Certifications This device is equipped to operate at 100-120 / 200-240 VAC, 50/60 Hz, 40 VA, and is
designed to comply with IEC 60601-1 (2nd and 3rd Edition Amendment 1) and IEC 60601-1-2
(2nd, 3rd, 4th Edition) standards, including national differences. Special precautions regarding
Electro-magnetic Compatibility (EMC) are required for installation and use of this injection
system. Detailed EMC information can be found in Appendix A of this manual.
Indications For Use The ISI module option is indicated for the specific purpose of allowing an injector to interface
with a CT scanner.
Contraindications The ISI module is not to be used for any other use for which the device is not indicated. This
device is not to be used for drug infusion, chemotherapy, or any other use for which the device
is not indicated. The ISI module is not intended for portable use.
Restricted Sale Federal (USA) law restricts these devices for sale except by or on the order of a physician.
Disclaimers External wiring and modifications disclaimers: Bayer disclaims liability for any modifications to
this product or interfaces with other equipment that are not in conformity with the specifications
and information contained within this manual.
Anyone who connects additional equipment to the device or configures a medical system is
responsible that the system complies with the relevant requirements of IEC 60601-1. Any
accessory or equipment connected to the device must be certified to either IEC 60601-1
(Operator or Patient Environment Use) or, outside the patient environment, the level of safety
must be equivalent to equipment complying with their respective IEC or ISO safety standards,
e.g. IEC 62368-1 or IEC 60950-1 (Operator Environment Use Only), and must comply with the
relevant requirements according to IEC 60601-1. Consult with Bayer for any modifications to
the equipment.
Screen images in this manual are for illustration purposes only. Actual screens may vary.

MEDRAD®Stellant ISI 700 Module Operation and Installation Manual
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Monitors In some countries, the MEDRAD®Stellant CT Injection system may be purchased with a
choice of two monitors, shown below - "Display and Control Unit (DCU)" and "Certegra®
Workstation." The Certegra Workstation comes in two models, shown below as Model 1 and
Model 2. The Certegra Workstation hardware buttons differ slightly between Models but the
screen/monitor information remains the same.
Throughout the manual, "Display and Control Unit (DCU)" and "Certegra Workstation" will be
used to refer to the two when there are differences in how information is presented on the
screens.
Symbols The following symbols are used on the ISI module:
Certegra®Workstation (Model 1) Certegra®Workstation (Model 2)
Manufacturer (ISO 15223-1, 5.1.1)
Date of Manufacture (ISO 15223-1, 5.1.3)
Catalog Number (ISO 15223-1, 5.1.6)
Serial Number (ISO 15223-1, 5.1.7)
Part Number
Authorized Representative in the European
Community (ISO 15223-1, 5.1.2)
This Side Up (ISO 7000, 0623)
Fragile, Handle With Care (ISO 15223-1,
5.3.1)
PN
Display and Control Unit (DCU)

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Keep Dry (ISO 15223-1, 5.3.4).
Medical - General Medical Equipment As
To Electrical Shock, Fire, and Mechanical
Hazards Only In accordance with ANSI/
AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN/CSA-C22.2 No. 60601-1 (2014)
Indicates that this device conforms to the
requirements of the European Medical
Device Directive 93/42/EEC.
Attention: Refer to warnings and cautions
on Instructions for Use packaged in each
carton. (ISO 15223-1, 5.4.4)
Warning: Indicates hazardous voltages.
(ISO 7010, W012)
Indicates alternating current. (IEC 60417,
5032)
Indicates scanner connection.
Identifies a terminal suitable for direct
current. (IEC TR 60878, 5031)
Indicates injector connection.
Identifies the Equipotential connection.
(IEC TR 60878, 5021)
Indicates separate collection for Electrical
and Electronic Equipment per Directive
2002/96/EC. Refer to the following website
for additional information:
www.weee.bayer.com
Indicates the ISI module is Class 1 medical
equipment as defined by IEC 60601-1
standards.
CLASS 1

MEDRAD®Stellant ISI 700 Module Operation and Installation Manual
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The following icons may appear on the injector screen for those who have the
Display and Control Unit (DCU):
The injector is configured for ISI and it is communicating to the ISI module. The scanner
signals are in a state that will allow arming the injector.
The user is not able to arm the injector. The injector is configured for ISI, and it is
communicating to the ISI 700 module. The injector and ISI module are functional, but the
scanner signals are in a state that will NOT allow arming the injector.
Communication is lost between the injector and the ISI module.
OR
The ISI module is in need of repair. Refer to the ISI System Messages section of this manual.
The following icons may appear on the injector screen for those who have a
Certegra Workstation:
The injector is configured for ISI and it is communicating to the ISI module. The scanner
signals are in a state that will allow arming the injector.
The user is not able to arm the injector. The injector is configured for ISI, and it is
communicating to the ISI 700 module. The injector and ISI module are functional, but the
scanner signals are in a state that will not allow arming the injector.
Communication is lost between the injector and the ISI module.
OR
The ISI module is in need of repair. Refer to the ISI System Messages section of this manual.
Scanner ready.
When icon is gray, Injector is not Armed and not ready for injection. When icon is highlighted in
yellow and flashing, Injector is armed and ready of the injection.
IPX1 Code that specifies the degree of
protection provided by the enclosure
against vertically falling water drops (IEC
60529)
Identifies the Protective Earth Ground
point. (IEC TR 60878, 5019)
See accompanying documentation. This
symbol indicates the user shall refer to the
instructions-for-use to ensure safe
operation. (ISO 7010, M002)
Consult instructions for use. (ISO 15223-1,
5.4.3)

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Procedure request can be initiated from EITHER the scanner or the injector. When either or
both system symbol (Injector and Scanner) is gray, that system is not ready and injection will
not proceed. When both the symbols are highlighted in yellow and flashing, both the systems is
ready and the injection can proceed.
Test inject is programmed, test inject can be started only from the injector. When injector
symbol is gray, injector is not ready and test inject will not proceed. When injector is highlighted
in yellow, injector is ready and the test inject can proceed.
The following symbols appear throughout this manual.
WARNING: Indicates that the information is a warning. Warnings advise you of circumstances
that could result in injury or death to the patient or operator. Read and understand the warnings
before operating the injection system.
CAUTION: Indicates that the information is a caution. Cautions advise you of circumstances
that could result in damage to the device. Read and understand the cautions before operating
the injection system.
NOTE: Indicates that the information that follows is additional important
information or a tip that will help you recover from an error or point you
to related information within the manual.
Warnings Improper installation of the ISI module may cause it to fail. Installation must be
completed by properly trained personnel. Contact your scanner manufacturer for
configuration and installation assistance.
Patient injury could result from using improper accessories. Use only accessories and
options provided by Bayer designed for this system.
Explosion hazard: Patient injury could result from using the injection system in the presence
of flammables (such as anesthetics). Do not use the system when flammables are present.
Fire hazard: Patient injury could result from using incorrect fuses. To avoid an electrical fire,
assure the correct type of fuse is used for replacement. The fuse must be replaced with Type T,
250 V, 2 A fuse by qualified personnel only.
Shock hazard: Patient injury could result from worn cabling or unit disassembly. To avoid
exposure to potentially hazardous voltages, do not disassemble the ISI module in any way.
Worn cabling also creates hazards. If any worn or damaged cables are detected, do not use
the ISI module. Contact Bayer or your local dealer for service or replacement.
Only use the power cord supplied with the system. Do not plug the power cord into an
extension cord or multi-outlet power strip.
Patient or operator injury may result if damaged components are used. Do not use
damaged components. Visually inspect all components before use.
Electrical Shock hazard: Equipment must only be connected to a supply mains with
protective earth.
The system should not be serviced or maintained while in use with a patient.

MEDRAD®Stellant ISI 700 Module Operation and Installation Manual
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Cautions System damage may occur if voltage is applied to J1 Pins 16, 18, 23, 25, 27, or 33. Only
connect these pins to isolated switch or relay contacts in the scanner.
Damage can occur as a result of incorrect voltage. Verify that the voltage and frequency
marked on the serial tag on the back of the unit matches the voltage and frequency of the
electrical outlet.
To remove main power from the equipment, disconnect the power cord from the appliance
inlet. Ensure the equipment is positioned so that the appliance inlet is accessible for power
cord disconnection.
System malfunction may be caused by failure to perform regular maintenance. Regular
preventive maintenance is recommended to ensure that the system stays calibrated and
functions properly. Refer to this manual or contact Bayer for additional information.
Do not expose system components to excessive amounts of water or cleaning solutions.
Disconnect power before cleaning. Wipe components with a soft cloth or paper towel
dampened with cleaning solution.
Do not use strong cleaning agents and solvents. Warm water and a mild disinfectant are all that
are required to clean the injector. Do not use strong industrial cleaning solvents such as
acetone.
NOTE: Bayer can only be responsible for proper injector and scanner
interaction if they are configured exactly as specified. The injector and
scanner will operate as described in this section only if the ISI module
is installed according to this manual and the scanner is capable of
accepting these signals via the interface.
Installation Caution: Equipment damage may result or system may fail to operate. The system is
meant to connect the following CT injection systems with a CT scanner and should not be used
with other medical devices or medical device technologies. Catalog Numbers:
SCT 110, SCT 111, SCT 112, SCT 120, SCT 121, SCT 122, SCT 210, SCT 211, SCT 212, SCT
220, SCT 221, SCT 222, SCT-310, SCT-321, SCT-322, FLEX, and FLEX UPG.
The ISI module kit contains the following items.
1. ISI module assembly
2. Power cord
3. Injector to ISI cable
4. ISI Module Operation and Installation Manual (this manual)
5. ISI Communication Safety Label (used on Certegra Workstation only)

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To install the ISI module:
1. Unpack the ISI module.
2. Connect the ISI module communication cable to injector base.
3. Connect interface cable from scanner to ISI module.
4. Connect the power cable to the ISI module. Ensure power indicator is illuminated.
5. If a Certegra Workstation is being installed as an upgrade to an existing injector with an
ISI 700 option, determine whether or not the base has a hub installed (pictured below).
P115
1. ISI module assembly
2. Power cord
3. Injector to ISI cable
Scanner cable
(Provided by scanner
manufacturer)

MEDRAD®Stellant ISI 700 Module Operation and Installation Manual
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If the base has a hub installed, remove it and replace it with a switch, catalog number
SWITCH301 (pictured below).
6. MEDRAD®Stellant CT Injection System with Certegra®Workstation (Stellant CWS) and
MEDRAD®Stellant FLEX CT Injection System with Certegra® Workstation (Stellant
FLEX) ONLY - The label sheet 60728249 contains two labels for each translation. Apply
one to the injector head as shown on the label sheet 60728249. Do not use the second
label. Certegra Workstation should not have a label applied to it.
MEDRAD®Stellant CT Injection System (Stellant Classic), skip this step. These do not
apply to the Stellant Classic.
Operational Checkout A basic functional checkout of the ISI module should be included as part of regular
maintenance. Verifying proper operation of the ISI module will help in detection of any
problems that may not be noticed in day to day operation. The following procedure represents
a suggested series of activities which encompass typical operation of the system. Read the
following procedure carefully before beginning the checkout. If problems are detected, call your
Services Representative.
NOTE: Any problems detected during this or any other procedure should be
corrected before using the injection system in patient procedures.
1. Ensure that all system safety and warning labels are in place and legible.
2. Apply power to the system.
3. Refer to the Configuration and Details of Operation sections below.
4. Verify that all displays and indicators are functioning properly.

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Configuration
a. If you have the Display and Control Unit (DCU), press the setup button, below. Note
that this button is a physical, rubber button and not a touchscreen button.
b. If you have a Certegra Workstation, press the following touchscreen buttons:
Overview of Operation For the most efficient and error free operation of a CT scan, the injector and scanner should be
interfaced. Interfacing is the process by which signals are transmitted and coordinated
between the injector and scanner.
The injection system does not control the imaging system via the ISI module. The ISI notifies
the scanner of the injector status which enables the scanner to synchronize the scan timing
based upon when the injection started. The scanner controls the start of the scan sequence
after it has received the injection start status and will not start the scan unless the scanner is in
the correct state. The scanner system maintains full control of the radiation initiation.
The ISI module supports the following two methods:
1. By pressing the injector start switch the injector notifies the scanner that it can begin the
scanning sequence.
2. The scanner initiates the entire scanning sequence by starting the scanner and notifying
the injector that it can start.
At the time of installation, the scanner installer may select one of the above modes of
operation.
When the injection complete screen appears, do not press “OK” on the Display and Control
Unit (DCU), or the "Same Patient" or "New Patient" buttons on the Certegra Workstation until
the scanner is finished scanning and the procedure is complete. Doing so will send a request to
the scanner to stop the scan. If the injector disarms prematurely, it will send the request to stop
1. Configure the ISI module on the injector setup screen by first accessing Setup. To
access Setup, do the following depending on your Monitor.
i. Press this button ii. Then this button iii. Then this button
2. After installation and configuration have been performed successfully, you
will see the following icon.
3. Program the scanner. You will see the following icon when the scanner is
ready.

MEDRAD®Stellant ISI 700 Module Operation and Installation Manual
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the scan immediately regardless of you pressing "OK," "Same Patient," or "New Patient" on the
injection complete window.
It is recommended not to program Hold phases in the injection protocol when using the ISI
feature unless directed by the scanner manufacturer. If the scanner manufacturer does not
support sending a (re)start request to the injector in the Hold phase, it will require you to press
the start button manually on the injector to exit the Hold phase and continue the injection
protocol. Contact your scanner manufacturer to determine if it supports the restart from Hold
feature.
NOTE: The scanner manufacturer and/or user make the final determination
of the mode of operation for the interfaced injector and scanner. The
scanner manufacturer is responsible for providing operation
instructions for their system.
Injector Head Indicator
Lights
For Certegra Workstation, some behaviors of the injector head arm indicator lights (the blue
and green indicator lights around the manual fluid movement knobs) have been modified.
In independent and monitored operation, where the injector cannot request the scanner to
start, the arm lights on the injector head flash once per second when the injector is armed.
In coupled operation with the scanner where the injector may request the scanner to start (the
injector will be labeled as described in the symbols section), the arm lights flash approximately
twice per second with a "short flash, long flash" pattern.
Details of Operation 1. Program the scanner. You will see the ISI Ready icon when the scanner is ready.
2. Program the injector.
3. Arm the injector.
NOTE: For specific information about programming, arming and injecting,
refer to the specific injection system Operation Manual.
4. Execute procedure.
• Press start switch on either scanner or injector to enable the scan/inject
sequence.
Hold and Test Inject
features
If you are starting the procedure from the injector the following applies.
1. If a "Test Inject" is selected on the injector, the scanner will not be Requested to Start
when the test inject is being initiated. The injector will inject the test bolus as programmed,
and then go into an automatic Hold which is part of the "Test Inject", but the scanner will
not be requested to start.
2. Once the Test Injection is determined to be "normal," the next step would be for the user
to depress the Start Switch again, which would start the injection of the primary bolus. It is
at this time of the second start switch depression that the scanner would be Requested to
Start.
If a Hold is manually programmed into any phase of the injection protocol, the ISI will treat them
as a standard injection phase (the "Request to Scan" command will continue to be given during
the Hold and Pause phase).
NOTE: It is not recommended to program a Hold phase into an injector
protocol unless the scanner supports the "injector ready" functionality.
Otherwise, to continue the injection from a Hold phase you must
manually press start on the injector to exit the Hold. To find out if the
scanner supports the "injector ready" functionality, contact your
scanner manufacturer.

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Scan Delay If the injection system software version is 17A or higher, the scan delay must be programmed
from the scanner.
ISI Module Cables Maintenance: A periodic inspection of the ISI Interface Cables is a recommended to ensure
that there are no obvious defects, such as cuts or breaks in the cable, which could disrupt
signal integrity. Ensure that the connectors are properly seated.
NOTE: Scanner specific cables are typically available from the scanner
manufacturer. Contact the scanner manufacturer for details.
Power Cable
Specifications
The specifications required by the MEDRAD®Stellant Imaging System Interface (ISI) 700
Module relative to the power cable (plug, receptacle, and cord) are:
• Operating Temperature: 60°C minimum
• Receptacle Type: IEC-60320 C13
• Normal Cord Voltage: 300 VAC minimum
• Wire Gauge: 1.00 mm2minimum
• Cord Type: IEC 60245-1, Annex A, Designation 53, or IEC 60227-1,
Annex A, Designation 53 Certified
• Cord Length: 3 m maximum
The power cable must meet applicable plug, cord, and receptacle specifications including type,
voltage, current, and safety approval markings for the country in which the power cable is being
used.
ISI Module System
Messages and
Descriptions
The text box messages appear on the injector screen.
Text Box Message What it means Actions to be taken
Display and Control Unit (DCU):
“Scanner not ready”
Certegra Workstation:
"Imaging system not ready"
When the ISI module is configured "On", or
when the user attempts to arm the injector,
the system checks for the signal, "Scanner
Ready." If the scanner is not ready, this
message results.
Ensure the scanner is ready. Check that all
cabling between the injector, ISI module,
and scanner are connected. Ensure power
indicator on ISI module is lit.
Display and Control Unit (DCU):
"Injector Disarmed by Scanner"
Certegra Workstation:
"Injector Disarmed by Scanner"
The injector was "Armed" or injecting, and
a disarm signal was received from the
scanner.
OR
The ISI module is not communicating with
the Injector and an attempt is made to
Arm.
In some cases, this can be normal
operation. However, if this message was
received in error, then check to ensure that
all cabling between the injector, ISI module,
and scanner are connected. Ensure that
the scanner is properly configured.
Display and Control Unit (DCU):
"ISI module not ready"
Certegra Workstation:
Not Applicable -- No message
This message appears when two events
occur simultaneously:
(1) The user is trying to configure the ISI
module, and
(2) The injector is not communicating with
the ISI module.
Check to ensure that all cabling between
the injector, ISI module, and scanner are
connected. Ensure power indicator on ISI
module is lit.

MEDRAD®Stellant ISI 700 Module Operation and Installation Manual
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NOTE: If the problem cannot be rectified, go to the injector setup screen
to configure ISI "Off." Manually start the injector and scanner
separately to complete the procedure. Call for service.
NOTE: Follow the error instructions on the display and/or contact Bayer
for further support.
Schematic Diagram
Note:
Maximum rating for scanner relay contacts: 0.75 A @ 30 VDC
Minimum rating for scanner relay contacts: 10 µa @ 10mV.
Display and Control Unit (DCU):
"ISI module failure"
Certegra Workstation:
"ISI module failure"
The ISI module did not pass a self-test. Unplug the power cable to the ISI module,
then re-plug.
Input
Output
ISI
Output
Input
Scanner
Scanner Ready
Injector Disarm
Start Injector Request
Isolated+5V
Injector Ready
Start Scanner Request
Scanner Disarm Request

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Signals and Descriptions
*The ISI scanner interface is a 37-pin D shell connector (J1), located on the ISI module. The
following signals are provided to work properly with the scanner.
**The scanner manufacturer is responsible for assuring the scanner will not respond to a Scan
Start signal until it is safe to do so.
Caution: System damage may occur if voltage is applied to J1 Pins 16, 18, 23, 25, 27,
or 33. Only connect these pins to isolated switch or relay contacts in the scanner.
Signal Operation Description *J1Pin
Numb er
Voltage Logic
Scanner Ready
This is an input signal from the scanner to the injector. It tells the injector that the scanner is ready. This signal ensures that the injector cannot be armed unless the scanner is ready. This signal is used to prevent a condition where you could receive contrast media but no scan.
When the signal is high, it allows the injector to arm. If the user wants to arm the injector, and this signal is low, the injector cannot be armed.
25 If +5v is switched from pin 16
to 25 by the scanner, the injector can be armed. If pin 25 is zero volts, the injector cannot be armed.
Injector Disarm
This is an input signal from the scanner to the injector. It allows the scanner to stop the injection at any time by disarming it. This signal would immediately stop the injection of contrast.
If the injector is armed (this signal would be high), making this signal go to zero disarms the injector.
25 Note that pin 25 performs a
dual function. If it is high (+5v) the injector is allowed to arm. If it goes low (0v), it will disarm the injector.
Start Injector Request
This is an input signal from the scanner to the injector. It allows the scanner to request that the injector start injecting. If the injector is armed, and the scanner initiates a "Start Request", fluid will be delivered, otherwise the signal is ignored.
The signal from the scanner is normally low. When it goes high, the "Start Request" is sent to the scanner.
27 Pin 27 is normally at 0v.
When the scanner switches the isolated 5v from pin 16 to pin 27, the "Start Request" is made.
Injector Ready
This is an output signal from the injector to the scanner indicating the injector is armed or holding. When the scanner is initiating the entire scanning sequence, this signal is used to notify the scanner that the injector is ready to accept a start or has entered a "hold" phase. The injector will start when receiving a "Start injector request."
An injector Ready signal is sent to the scanner once the injector is armed.
1 & 2 The scanner provides a
signal on pin 2 of J1. When the injector is armed, this signal is switched back to the scanner through pin 1. The signal is low while injecting.

MEDRAD®Stellant ISI 700 Module Operation and Installation Manual
14
Environmental
Specifications
Non-Operating: (Transportation and Storage)
Temperature: -25oC to 70oC (-13oF to +158oF)
Humidity: 5% to 100% R.H., non-condensing
Air Pressure: 48 kPa to 110 kPa
Operating:
(The system may not meet all performance specifications if operated outside of the following
conditions.)
Temperature: +10oC to + 40o C (+50oF to +104oF)
Humidity: 20% to 90% R.H.
Air Pressure: 69 kPa to 110 kPa
Protection Against Electrical Shock
Per IEC 60601-1, the ISI module is designed as a Class 1 Medical Device.
Class 1 Equipment requires a protective earth connection (electrical grounding) to ensure
protection against electrical shock in the event of a failure of the basic insulation system. The
following are requirements for a Class 1 Medical Device.
EMI/RFI
The injection system is classified as Group 1, Class A equipment per the requirements of IEC
60601-1-2. Accessories provided by Bayer will also comply with this standard.
Electrical Leakage:
Complies with AAMI, UL, CSA and IEC requirements for safe Electrical Leakage Current limits
for Medical Equipment:
Earth and Chassis Leakage Current:
< 300 microamps
Patient Connection Leakage Current:
< 10 microamps
Ground Continuity:
< 0.1 ohms from power cord ground pin to base, DCU, or head enclosure.
Protection Against the Ingress of Fluids:
Per IEC 60601-1, the ISI module has been classified as drip proof. This is indicated by the
IPX1 designation on the ISI module.
NOTE: In the event of fluid ingress or spillage on the injection system ensure
all equipment and accessory connections are removed, dried, and
inspected. Follow hospital policies and procedures or contact Bayer
for performing appropriate electrical safety and operational checks
prior to use.