14
15
9. ELECTROMAGNETIC EMISSIONS
10. ELECTROMAGNETIC IMMUNITY
NOTES
•
The I-PEN
®
requires special precautions with regard to electromagnetic compatibility.
•
It must be installed and prepared for use as described in Section 4. Performing an Osmolarity
Measurement.
•
Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere
with the I-PEN
®
.
•
The recommended separation distances in this paragraph must therefore be complied with.
•
The I-PEN
®
must not be used near or on top of another device. If this cannot be avoided, it is necessary
– before clinical use – to check the equipment for correct operation under the conditions of use.
•
The use of accessories other than those specified or sold by I- MED Pharma Inc. as replacement parts
may have the consequence of increasing the emissions or decreasing the immunity of the unit.
•
I-PEN
®
is intended for use in the electromagnetic environment specified in the following tables.
This is not a life- sustaining device.
•
The user and/or installer of the unit must ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
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.
Emissions Test
Compliance
Electromagnetic Environment -
Guidance
RF emissions
Test: CISPR 11
Group 1
The I-PEN
®
uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000- 3- 2
Not applicable
Voltage fluctuations/flicker
emissions IEC 61000- 3-3
Not applicable
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
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±8 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV
for power supply lines
±1 kV
for input/ Output lines
Not applicable
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
Not applicable
Voltage fluctuations/
flicker emissions IEC
61000- 3-3
<5 %UT
(>95 %dip in UT)
for 0.5 cycle
40 %UT
(60 %dip in UT)
for 5 cycles <5 %UT
70 %UT
(30 %dip in UT)
for 25 cycles
<5 %UT <5 %UT
(>95 %dip in UT)
for 5 s
Not applicable
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
public low-voltage power
supply network that supplies
buildings used for domestic
purposes, commercial or
hospital, clinic environment.
I-PEN
®
User Guide
|
ELECTROMAGNETIC EMISSIONS
I-PEN
®
User Guide
|
ELECTROMAGNETIC IMMUNITY