Bayer HealthCare MEDRAD 800 Module Bedienungsanleitung

CT Injection System

Operation & Installation Manual

MEDRAD® Stellant Imaging System Interface (ISI)

800 Module

MEDRAD®Stellant Imaging System

Interface (ISI) 800 Module

Operation and Installation Manual

Operating specifications, options, accessories, and feature availability may

vary by country. Check with local product representative and country-specific

operating instructions.

The MEDRAD®Stellant Imaging System Interface (ISI) 800 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) 800 Module can be found in Section 1 of this manual.

English

ii ii

MEDRAD®Stellant ISI 800 Module Operation Man-

1 - Introduction ............................................................................. 3

Installation ......................................................................................................3

Important Safety Notice ..................................................................................3

Indications For Use ........................................................................................3

Certifications ..................................................................................................3

Contraindications ...........................................................................................3

Restricted Sale ............................................................................................... 3

Disclaimers ..................................................................................................... 3

Monitors ......................................................................................................... 4

Symbols ......................................................................................................... 4

Warnings ........................................................................................................8

Cautions ......................................................................................................... 8

Notes ..............................................................................................................9

System Overview ........................................................................................... 9

CiA 425 Standard. .......................................................................................... 9

Injector Modes ..............................................................................................10

Lockouts ....................................................................................................... 10

2 - Operation ............................................................................... 11

Overview of Operation ................................................................................. 11

Injector Head Indicator Lights ......................................................................11

Details of Operation (Monitor Mode) ............................................................ 11

Details of Operation (Tracking and Control Modes) .....................................14

Test Inject ..................................................................................................... 17

3 - Specifications ........................................................................ 19

ISI 800 Enclosure Dimensions .....................................................................19

Power Cords ................................................................................................ 19

Environmental Specifications .......................................................................20

Appendix A - Compliance to IEC 60601-1-2 / 2nd, 3rd, and 4th

Editions ....................................................................................... 21

MEDRAD®Stellant ISI 800 Module Operation Manual

1 - Introduction

This manual contains important information about use of the MEDRAD®

Stellant Imaging System Interface (ISI) 800 Module (Catalog Number: ISI

800).

Read all the information contained in this manual. Understanding this

information will assist the user in safely operating the System.

Installation Contact Bayer for Installation information.

Important Safety

Notice

The ISI 800 Module 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 800 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. The ISI 800 Module supports the Class 1 standard of

the CAN Open for add-on Medical Devices.

Indications For Use The ISI 800 Module option is indicated for the specific purpose of allowing an

injector to interface with a CT scanner.

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, and 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.

Contraindications None.

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 Bayer for any modifications to the equipment.

Screen images in this manual are for illustration purposes only. Actual

screens may vary.

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 800 Module and its components:

Certegra®Workstation (Model 1) Certegra®Workstation (Model 2)

Icon Meaning

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)

TX Identifies the CAN Interface TRANSMIT LED.

RX Identifies the CAN Interface RECEIVE LED.

Display and Control Unit (DCU)

MEDRAD®Stellant ISI 800 Module Operation Manual

LK Identifies the Ethernet LINK LED.

AT Identifies the Ethernet ACTIVITY LED.

CLASS 1 Indicates the ISI 800 Module is Class 1 medical equipment as defined by

IEC 60601-1 standards.

IPX 1 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)

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

Symbols on the Power Switch: (IEC TR 60878: 5007, 5008)

I - On

O - Off

Authorized representative in the European community.

(ISO 15223-1, 5.1.2)

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.

This side up. (ISO 7000, 0623)

Keep dry. (ISO 15223-1, 5.3.4)

Fragile, handle with care (ISO 15223-1, 5.3.1)

The following icons may appear on the injector screen:

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).

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)

Icon Meaning

Communication between the injector and the scanner has been

established via the ISI 800 Module, which means it is communicating with

both the scanner and the injector.

The ISI 800 Module is communicating with the injector.

The ISI 800 Module is not communicating with the injector.

This icon indicates the injector and scanner are functioning independently.

This icon is also used when the injector is operating without an ISI 800

Module. The Display and Control Unit (DCU) icon is shown. On the

Certegra®Workstation, the icon is the same but is vertical.

The configurations below are determined by the scanner manufacturer. Refer to the scanner

manufacturer instructions for further information. The following description applies to the four icons

below.

1. If the injector and/or scanner icon is gray, as shown below, it is not ready.

2. If the injector icon is yellow but not flashing, it is ready but is waiting for the scanner to be ready.

3. If the scanner icon is yellow but not flashing, it is ready but is waiting for the injector to be ready.

4. If the injector icon is yellow and flashing, an injection can be initiated whether or not the scanner is

ready.

5. If the injector and scanner icons are yellow and flashing, the procedure (injection plus scan) can be

initiated by pressing the start button specified below.

’When no arrow is shown between the injector and the scanner, a test

injection is programmed -- a test injection can be started only from the

injector. When the injector icon is highlighted in yellow and blinking, the

injector is ready and the test injection can proceed. After the test injection

is completed, one of the three arrows, as shown below, will appear.

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