Stellant series 700 Module Operation and Installation Manual Rev F Feb 2019

English

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 countryspecific 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.

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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

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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.

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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.

Display and Control Unit (DCU)

Symbols

Certegra® Workstation (Model 1)

Certegra® Workstation (Model 2)

The following symbols are used on the ISI module: 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)

PN

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)

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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

CLASS 1

Indicates the ISI module is Class 1 medical equipment as defined by IEC 60601-1 standards.

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MEDRAD® Stellant ISI 700 Module Operation and Installation Manual

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)

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.

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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:

Warnings

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.

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.

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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:

Installation

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.

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. 2. 3. 4. 5.

ISI module assembly Power cord Injector to ISI cable ISI Module Operation and Installation Manual (this manual) ISI Communication Safety Label (used on Certegra Workstation only)

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To install the ISI module: 1. 2. 3. 4.

Unpack the ISI module. Connect the ISI module communication cable to injector base. Connect interface cable from scanner to ISI module. Connect the power cable to the ISI module. Ensure power indicator is illuminated. 1. ISI module assembly

2. Power cord

3. Injector to ISI cable

Scanner cable (Provided by scanner manufacturer)

P115

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).

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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: 1. 2. 3. 4.

Any problems detected during this or any other procedure should be corrected before using the injection system in patient procedures.

Ensure that all system safety and warning labels are in place and legible. Apply power to the system. Refer to the Configuration and Details of Operation sections below. Verify that all displays and indicators are functioning properly.

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Configuration

1.

Configure the ISI module on the injector setup screen by first accessing Setup. To access Setup, do the following depending on your Monitor. 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: 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. 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

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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:

Injector Head Indicator Lights

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.

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. 2. 3.

Program the scanner. You will see the ISI Ready icon Program the injector. Arm the injector.

when the scanner is ready.

NOTE: 4.

Hold and Test Inject features

For specific information about programming, arming and injecting, refer to the specific injection system Operation Manual. Execute procedure. • Press start switch on either scanner or injector to enable the scan/inject sequence.

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:

Power Cable Specifications

Scanner specific cables are typically available from the scanner manufacturer. Contact the scanner manufacturer for details.

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 mm2 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”

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.

The injector was "Armed" or injecting, and a disarm signal was received from the scanner.

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.

Certegra Workstation: "Imaging system not ready" Display and Control Unit (DCU): "Injector Disarmed by Scanner" Certegra Workstation: "Injector Disarmed by Scanner"

OR The ISI module is not communicating with the Injector and an attempt is made to Arm.

Display and Control Unit (DCU): "ISI module not ready"

This message appears when two events occur simultaneously:

Certegra Workstation: Not Applicable -- No message

(1) The user is trying to configure the ISI module, and

Check to ensure that all cabling between the injector, ISI module, and scanner are connected. Ensure power indicator on ISI module is lit.

(2) The injector is not communicating with the ISI module.

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MEDRAD® Stellant ISI 700 Module Operation and Installation Manual

The ISI module did not pass a self-test.

Display and Control Unit (DCU): "ISI module failure"

Unplug the power cable to the ISI module, then re-plug.

Certegra Workstation: "ISI module failure" NOTE: 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. Follow the error instructions on the display and/or contact Bayer for further support.

Scanner Scanner Disarm Request

Input Start Scanner Request

Injector Ready

ISI

Output

Isolated+5V

Start Injector Request

Input

Injector Disarm

Scanner Ready

Output

Schematic Diagram

Note: Maximum rating for scanner relay contacts: 0.75 A @ 30 VDC Minimum rating for scanner relay contacts: 10 µa @ 10mV.

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Operation

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. 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. 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. 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."

Signal

Scanner Ready

Injector Disarm

Start Injector Request

Injector Ready

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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.

Pin 27 is normally at 0v. When the scanner switches the isolated 5v from pin 16 to pin 27, the "Start Request" is made.

27

The signal from the scanner is normally low. When it goes high, the "Start Request" is sent to the scanner.

An injector Ready signal is sent to the scanner once the injector is armed.

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.

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.

25

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.

If the injector is armed (this signal would be high), making this signal go to zero disarms the injector.

Voltage Logic

*J1 Pin Numb er

Description

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.

MEDRAD® Stellant ISI 700 Module Operation and Installation Manual

Environmental Specifications

Non-Operating: (Transportation and Storage) Temperature:

-25o C to 70o C (-13o F to +158o F)

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:

+10o C to + 40o C (+50o F to +104o F)

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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Mode of Operation: Per IEC 60601-1 the mode of operation for the ISI module is continuous. It is capable of operation under normal load for an unlimited period, without excessive temperature being developed.

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