Bayer HealthCare MEDRAD Stellant Operation and Installation Manual

Brand: Bayer HealthCare

Model: MEDRAD Stellant

Category: Measuring, testing & control

Type: Operation and Installation Manual

CT Injection System

Operation and Installation Manual

MEDRAD® Stellant Imaging System Interface (ISI)

700 Module

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

iii

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

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

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)

Display and Control Unit (DCU)

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

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.

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.

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)

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

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)

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

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.

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

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.

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 mm

minimum

• 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.

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

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

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 *J1 Pin

Numb

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

Environmental

Specifications

Non-Operating: (Transportation and Storage)

Temperature: -25

C to 70

C (-13

F to +158

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: +10

C to + 40

C (+50

F to +104

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.

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Bayer HealthCare MEDRAD Stellant Operation and Installation Manual

Brand: Bayer HealthCare

Model: MEDRAD Stellant

Category: Measuring, testing & control

Type: Operation and Installation Manual

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Bayer HealthCare MEDRAD Stellant Operation and Installation Manual

Bayer HealthCare MEDRAD Stellant Operation and Installation Manual

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