Installation and User Manual
24 Pages
Preview
Page 1
Installation & User Manual ISI2 Module
ISI2 Module Installation & User Manual
ISI2 Module Installation & User Manual The ISI2 Module has an expected service life* of 8 years from the date of product installation when operated according to the instructions provided with this device. These 8 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 symbols can be found in Section 2 of this manual.
i
ISI2 Module Installation & User Manual
ii
ISI2 Module Installation & User Manual
1 Introduction ...1 1.1 Certifications ... 1 1.2 Indications for Use... 1 1.3 Training Information... 1 1.4 Contraindications... 1 1.5 Restricted Sales ... 1 1.6 Required Training... 1 1.7 Disclaimers... 2
2 Symbols ...3 2.1 General Symbols... 3 2.2 LED Identification... 5
3 Warnings, Cautions, and Notices ...7 3.1 Definitions... 7 3.2 Warnings ... 7 3.3 Notices ... 8
4 Specifications...9 4.1 Dimensions and Weight ... 9 4.2 Connections ... 9 4.2.1 Power Requirements ...10 4.3 Environmental Specifications ...10 4.3.1 Non-Operating (Storage and transport specifications ) ...10 4.3.2 Operating ...10 4.3.3 Protection Against Electrical Shock ...10 4.3.4 EMI/RFI...10 4.3.5 Protection Against the Ingress of Fluids ...10 4.3.6 Mode of Operation...11 4.4 Disposal ...11
5 Installation ...13 5.1 Installation ...13 5.1.1 ISI 700 ...13 5.1.2 ISI 900 ...14 5.1.3 Installation in a Mobile Environment ...14 5.1.4 Confirmation of Correct Installation ...15 5.1.5 ISI Configure Connectivity Settings ...15
iii
ISI2 Module Installation & User Manual
iv
ISI2 Module Installation & User Manual
1
Introduction
This manual applies to the ISI2 Module (ISI2) Catalog Number: ISI2. Read all of the information contained in this manual. Understanding this information will assist users in operating the system in a safe manner. NOTE: Operating specifications and feature availability may vary by country. Check with local product representatives and refer to country-specific operating instructions. The ISI2 Module can be connected to certain models of CT or MR scanners to exchange information and to synchronize actions. The ISI2 Module provides an interface between the following injection systems manufactured by Bayer and a CT or MR scanner. Q
MEDRAD® Centargo CT Injection System
Q
MEDRAD® MRXperion MR injection System
1.1 Certifications This device 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 and applicable 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 the operation manual for each specific injection system.
1.2 Indications for Use The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.
1.3 Training Information This manual is intended to provide procedural and technical information. Additional training information will be available in the following formats: Q
On-site initial installation and additional training as requested
Please contact Bayer or your local Bayer representative if any of these resources are needed.
1.4 Contraindications None known.
1.5 Restricted Sales Federal (USA) Law restricts this device to sale by or on the order of a physician.
1.6 Required Training This device is intended to be used by individuals with adequate training and experience in diagnostic studies in x-ray applications.
1
ISI2 Module Installation & User Manual
1.7 Disclaimers External wiring and modifications disclaimers: Bayer disclaims liability for any modifications 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 to ensure 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.
2
ISI2 Module Installation & User Manual
2
Symbols
2.1 General Symbols Warning: Refer to warnings and cautions on Instructions for Use packaged in each carton. (ISO 7010, W001) Attention: Refer to warnings and cautions on Instructions for Use packaged in each carton. (ISO 15223-1, 5.4.4)
MR
MR Unsafe: Known threat or poses a hazard in all MR environments as defined by the ASTM International Standards for MRI Device Marking. (IEC 62570, 7.3.3) Indicates that this device conforms to the requirements of the European Medical Device Directive 93/42/EEC. See accompanying documentation. This symbol indicates the user shall refer to the instructions-for-use to ensure safe operation. (ISO 7010, M002) Indicates separate collection for Electrical and Electronic Equipment per Directive 2002/96/ EC. Refer to the following website for additional information: http://www.weee.bayer.com.
10
This product contains certain toxic or hazardous substances or elements, and can be used safely during its environmental protection use period (indicated by the number in the middle of the logo). This product should be recycled immediately after its environmental protection use period has expired. Manufacturer (ISO 15223-1, 5.1.1)
Authorized Representative in the European Community (ISO 15223-1, 5.1.2)
Date of manufacture (ISO 15223-1, 5.1.3)
Temperature range (ISO 15223-1, 5.3.7)
Humidity range (ISO 15223-1, 5.3.8)
Serial number (ISO 15223-1, 5.1.7)
3
ISI2 Module Installation & User Manual
Part number
Catalog number (ISO 15223-1, 5.1.6)
This side up (ISO 7000, 0623)
Keep dry (ISO 15223-1, 5.3.4)
Fragile (ISO 15223-1, 5.3.1)
Net Weight (ISO 7000, 1321B)
Consult instructions for use. (ISO 15223-1, 5.4.3)
MD
4
Medical Device (ISO 15223-1, 5.7.7)
ISI2 Module Installation & User Manual
2.2 LED Identification
7
8
900
700
700
TX
RX
700
CAN
1 2 3 4 5 6
900
#
Icon
Function
#
1
PWR
ISI2 Module has power
2
ISI 900 - ISI2 Module and injector are communicating.
ISI 900 - CAN Communication: ISI2 Module and imaging scanner are communicating.
4
ISI 900 - CAN Communication: Data Received from scanner
3
5
7
ISI 900 - CAN Communication: Data Transmitted to scanner
ISI 700 - Imagining System Trigger: Injection has started and scanner can start the scanning. NOTE: Not applicable for MEDRAD® MRXperion MR Injection System
Icon
Function
ISI 700 - The injection system is connected to the ISI 700 injector port. 6
8
NOTE: Not applicable for MEDRAD® MRXperion MR Injection System ISI 700 - Injector ready for start: Injector is Armed and available to start the injection from the scanner. NOTE: Not applicable for MEDRAD® MRXperion MR Injection System
5
ISI2 Module Installation & User Manual
6
ISI2 Module Installation & User Manual
3
Warnings, Cautions, and Notices
3.1 Definitions WARNING
Indicates that the information is a warning. Warnings advise of circumstances that could result in injury or death to the patient or operator. Read and understand the warnings before operating the injection system.
CAUTION
Indicates that the information is a caution. Cautions advise of circumstances that could result in minor or moderate injury to the patient or operator. Read and understand the cautions before operating the injection system.
NOTICE:
Indicates that the information is a notice. Notices advise of circumstances that could result in damage to the device. Read and understand the notices before operating the injection system. Indicates that the information that follows is additional important information, a tip that helps with recovery from an error, or a reference to related information within the manual.
Note
3.2 Warnings WARNING Electro-Mechanical Hazard - Equipment damage may result or system may fail to operate. Q
Do not modify this equipment without authorization of the manufacturer. Patient or operator injury could result from unauthorized modification to the equipment.
Q
Do not service or perform maintenance on the injection system while in use with a patient.
Q
The system should be opened and serviced by qualified service personnel only.
Q
Do not remove any covers or disassemble the injector.
Q
Do not expose system components to excessive amounts of water or cleaning solutions.
Electromagnetic Interference Hazard - Serious patient and/or worker injury or death may result. Q
For proper operation, use only accessories and options provided by Bayer that are designed specifically for the system. Other non-Bayer approved accessories or options may cause equipment damage or may result in increased emissions or decreased immunity of the system. System accessories listed in the operation manual comply with the requirements of electromagnetic emissions and immunity standards IEC-60601-1-2 / 2nd, 3rd, and 4th edition.
Equipment damage may result or system may fail to operate. Q
The ISI2 box is meant to connect with the specific devices identified within this manual, and should not be used with other medical devices or medical device technologies.
7
ISI2 Module Installation & User Manual
3.3 Notices NOTICE: Equipment damage may result or system may fail to operate. Q
Use only approved cleaning agents to clean the ISI2 Module. Use of cleaning agents other than those that have been approved may damage the ISI2 module. Approved cleaning agents are: Q
Distilled water Ethanol, 96% Q Isopropyl alcohol, 70% Q Petroleum spirits (specified by IEC 62368 to be a reagent grade hexane with a minimum of 85 % n-hexane) Q
8
ISI2 Module Installation & User Manual
4
Specifications
4.1 Dimensions and Weight
700
TX
700
RX
700
CAN
NOTE: Listed weight and dimensions are approximate.
900
94 mm
900
152 mm
Dimensions:152mm X 94mm X 36.5mm Weight: 176 g (0.39 lbs)
700
700
TX
RX
700
1
CAN
4.2 Connections
4
900
3
900
2
5
9
ISI2 Module Installation & User Manual
#
Icon 700
1
900
3
Function
#
Icon
Function
ISI 700 Cable to Injector Connector
2
Identifies service Connector. (IEC TR 60878, 0717)
ISI 900 Cable to Injector Connector
4
ISI 700 Cable to Scanner Connector
ISI 900 Cable to Scanner Connector
5
4.2.1 Power Requirements Power is provided by the CRU via USB. External USB adapter is not required.
4.3 Environmental Specifications 4.3.1 Non-Operating (Storage and transport specifications ) Temperature:
-20 °C to 60 °C (-4 °F to 140 °F)
Humidity:
10% to 90% R.H., non-condensing
4.3.2 Operating NOTE: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°F)
Humidity:
20% to 90% R.H.
Air Pressure:
70 kPa to 106 kPa
4.3.3 Protection Against Electrical Shock ISI2 is a USB powered device that meets the Separation Device requirements as per IEC 60601-1 for interconnecting ME Equipment and other items of equipment of an ME System.
4.3.4 EMI/RFI Refer to the appropriate injector system operation manual for information regarding Compliance to Electromagnetic Compatibility, IEC 60601-1-2
4.3.5 Protection Against the Ingress of Fluids The ISI2 module has not been classified for protection against the ingress of fluids. NOTE:In the event of fluid ingress or spillage on the ISI2 module ensure all equipment and accessory connections are removed, dried, and inspected. Follow hospital policies and procedures or contact Service personnel for performing appropriate electrical safety and operational checks prior to use.
10
ISI2 Module Installation & User Manual
4.3.6 Mode of Operation Per IEC 60601-1 the mode of operation for the ISI2 module is continuous operation. They are capable of operation under normal load for an unlimited period, without excessive temperature being developed.
4.4 Disposal Dispose of system components or accessories properly. Follow local regulations for proper disposal or contact Bayer for assistance.
11
ISI2 Module Installation & User Manual
12
ISI2 Module Installation & User Manual
5
Installation
Both the scanner and injector must be configured to work together.
WARNING Patient and/or worker injury or equipment damage may result. Q
The ISI2 Module is MR unsafe and is not for use in the scan room. The ISI2 Module is a known threat or poses a hazard in all MR environments as defined by the ASTM International Standards for MRI Device Marketing.
CAUTION Equipment damage may result or system may fail to operate. Q
The ISI2 Module is meant to connect the following injection systems with a CT or MR Imaging scanner and should not be used with other medical devices or medical device technologies. Catalog Numbers: CENT-BAT, CENT-PED, CENT-OCS, MRXP
NOTE: The injection system does not control the imaging system via the ISI2 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. NOTE: The scanner CANNOT override any injector operation that is considered safety critical; for example, check for air, hold during an injection or stopping an injection. NOTE: The instructions to configure and use the ISI2 Module with a specific injection system are contained within the injector system operation manual (MEDRAD® Centargo CT Injection System) or in a separate addendum to this manual (MEDRAD® MRXperion MR Injection System). NOTE: Contact Bayer to determine if the version of software on your injector will support this feature.
5.1 Installation This interface requires an ISI2 box and proprietary cables between the scanner and the injector's CRU to communicate.
5.1.1 ISI 700 This section applies to the following injection system(s) Q
MEDRAD® Centargo CT Injection System Control Room
Scan Room
700
Scanner-supplied cable
ISI2 adapter cable
USB cable
ISI 700 side
Scanner
ISI2 box Figure 5 - 1: ISI 700 Scanner Connectivity
CRU
Injector
13
ISI2 Module Installation & User Manual
5.1.2 ISI 900 This section applies to the following injection system(s) Q
MEDRAD® Centargo CT Injection System
Q
MEDRAD® MRXperion MR Injection System Scan Room
Control Room 900
Scannersupplied cable
USB cable
OR
900
ISI 900 side
Scanner
ISI2 Module
CRU
Injector
Figure 5 - 2: ISI 900 Scanner Connectivity
5.1.3 Installation in a Mobile Environment This section applies to the following injection system(s) Q
MEDRAD® MRXperion MR Injection System
1.
Determine the desired location of the ISI2 module.
2.
Ensure that the bottom surface and the chosen surface are clean and free of debris.
3.
Remove the adhesive backing from one side of each 2 ¾” Dual-Lock strip. NOTE: Do not separate the strips of Dual-Lock from one another.
4.
Apply the exposed adhesive side of the Dual-Lock strips to the bottom of the ISI2 modules as shown in Figure 5 - 3: Dual-Lock on bottom of ISI2 Module
4 Dual-Lock Strips applied as shown Figure 5 - 3: Dual-Lock on bottom of ISI2 Module 5.
Press the strips firmly against the surface.
6.
Remove the remaining adhesive backing from each Dual-Lock strip and press ISI2 module into place. NOTE: Do not separate the strips of Dual-Lock from one another.
7.
14
Secure the cables using wire ties, tape, etc.
ISI2 Module Installation & User Manual
5.1.4 Confirmation of Correct Installation Once all physical connections are made between the CRU, ISI2 Module and scanner, confirm that the PWR LED indicator is illuminated. If the PWR LED indicator is not illuminated, check that all cable connections are secure. If the PWR LED indicator still fails to illuminate please contact Bayer.
5.1.5 ISI Configure Connectivity Settings Once all physical connections are made between the CRU, ISI2 Module and scanner, the injection system software must be configured to allow communication. Refer to the specific injector system operation manual for connectivity configuration instructions.
15