Medrad Mark 7 Arterion, Operation Manual

Page: 12 / 162

MEDRAD
®
Mark 7 Arterion Injection System
2 - 4
2.4 Additional Information Regarding Compliance to IEC 60601-1-2/2007
This section is intended to reflect conformance to IEC-60601-1-2 / 2007 3rd edition.
The following statements are notices. Notices advise of circumstances that could result in damage to
the device. Read and understand these cautions before operating the injector system.
Electro-Mechanical Hazard - Equipment Damage may result.
• For proper operation, use only accessories and options provided by Bayer that are
designed specifically for the injector system. Other non-Bayer approved accessories or
options may cause equipment damage or may result in increased emissions or decreased
immunity of the injector system. Injector system accessories listed in it’s operation
manual comply with the requirements of electromagnetic emissions and immunity
standards IEC 60601-1-2/2007 3rd edition.
• Injector may disarm or fail to operate when exposed to high magnetic fields. Portable and
mobile RF communications equipment can affect the injector.
• Do not use injector adjacent to or stacked with other equipment. If adjacent or stacked
use is necessary, the injector should be observed to verify normal operation in the
configuration in which it will be used.
NOTICE
Table 2 - 1: Recommended separation distances between portable and mobile RF communications equipment and the
injector
The injector is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the injector can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the injector as recommended below,
according to the maximum output power of the communications equipment
Rated maximum output
power of transmitter W
Separation distance according to frequency of transmitter
150 KHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
d
3.5
V
1
-------
p =
d
3.5
E
1
-------
p =
d
7
E
1
------
p =