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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The I-PEN
®
is intended for use in the electromagnetic environment specified below. The customer or the
user of the I-PEN
®
device should assure that it is used in such an environment.
Immunity Test
IEC 60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment-
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms 150kHz to
80MHz
3 V/m
80MHz to 2.5GHz
Not applicable
3 V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of the
I-PEN
®
, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1.17√P
d = 1.17√P 80 M Hz t o 800 MHz
d = 2.3√P 800 MHz t o 2.5 GHz
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
Distance in meters (m).
Field strengths from fixed R F
transmitters, as determined by
an electromagnetic site survey,
a
should be less than the compliance
level in each frequency range
Interference may occur in the
vicinity of equipment marked with
the following symbol:
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the I-PEN
®
is used exceeds the applicable RF compliance level above, the I-PEN
®
should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the I-PEN
®
.
10.1. RECOMMENDED SEPARATION DISTANCES
10.1.1. APPLICABLE STANDARDS
Recommended separation distances between portable and mobile RF communications
equipment and the I-PEN
®
The I-PEN
®
is intended for use in an electromagnetic environment in which radiated radio frequency disturbances
are controlled.
•
The user and/or installer of the unit can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile radio frequency communications equipment (emitters) and the
I-PEN
®
, according to the maximum output power of the equipment, as recommended in the table below.
Separation distance according to the frequency
of transmitter (m)
Rated maximum output
power of transmitter (W)
80MHz to 800MHz
d = 1.17 √P
800MHz to 2.5GHz
d = 2.3 √P
0.01
0.12
0.23
0.1
0.37
0.73
1
1.17
2.3
10
3.7
7.3
100
11.7
23
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 range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
The following list of standards applies to the I-PEN
®
Osmolarity Device:
•
IEC/EN/UL 60601-1: 2005 (3rd Ed.), Medical electrical equipment,
part 1: General requirements for basic safety and essential performance.
•
IEC/EN 60601-1-2: 2007, Medical Electrical Equipment- Part 1-2: General requirements
for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests.
•
IEC 62304: 2006, Medical Device Software – Software Lifecycle Processes.
•
ISO 15223: 2012, Medical devices – Symbols to be used with medical device labels,
labeling and information to be supplied – Part 1: General requirements.
•
ISO 10993- 1: 2009, Biological Evaluation for Medical Devices,
part 1 – Evaluation and testing within a risk management process.
I-PEN
®
User Guide
|
ELECTROMAGNETIC IMMUNITY
I-PEN
®
User Guide
|
ELECTROMAGNETIC IMMUNITY