Manufacturer's Declaration - Saphyr SP Manual De Usuario

4 - MANUFACTURER'S DECLARATION

Medical electrical equipment requires special precautions regarding EMC (electromagnetic
compatibility), and must be installed and put into service according to the EMC information
provided in the tables below. Mobile RF (radiofrequency) communications equipment such as
cell phones can affect the operation of the Saphyr. This equipment should be kept as far away
from the Saphyr and its accessories as possible to eliminate these effects.
The Saphyr is intended for use in the electromagnetic environment specified below.
The user should make sure the Saphyr is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
CEI 61000-3-2
Voltage fluctuations and flicker
emissions
CEI 61000-3-3
The Saphyr is intended for use in the electromagnetic environment specified below.
The user should make sure the Saphyr is used in such an environment.
Immunity
test
Electrostatic discharge
(ESD)
CEI 61000-4-2
Electrical fast transient/
burst
CEI 61000-4-4
Surges
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
electrical power lines
CEI 61000-4-11
Power frequency
magnetic field
(50/60 Hertz)
IEC 61000-4-8
Guidance and manufacturer's declaration – Electromagnetic emissions
Compliance
Group 1
Class B
Not applicable
Not applicable
Guidance and manufacturer's declaration – Electromagnetic immunity
Test level
CEI 60601
±6 kV on contact
±15 kV in the air
±2 kV for electrical
power lines
±1 kV for input/
output lines
±1 kV differential
mode
±2 kV common
mode
<5% UT
(dip >95% in UT)
for 0.5 cycle
40% UT
(dip = 60% in UT)
for 5 cycles
70% UT
(dip = 30 % in UT)
for 25 cycles
<5% UT
(dip >95% in UT)
for 5 seconds
100 A/m (50/60
hertz)
Electromagnetic environment – Guidance
The Saphyr uses RF energy only for its internal functions.
As a result, its RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
The Saphyr is suitable for use in all establishments, including in
the home and places connected directly to the public low-voltage
power grid that supplies power to residential buildings.
Compliance
level
±2, ±4, ±6 kV Floors should be made of wood, concrete, or
on contact ceramic tile. If floors are covered with synthetic
±2, ±4, ±6 ±8 materials, relative humidity should be at least 30%.
kV in the air
Not applicable
Not applicable
Not applicable
100 A/m Magnetic fields at power frequencies should be at
(50/60 hertz) levels characteristic of a representative location
in a typical commercial or hospital environment.
22
Electromagnetic
environment – Guidance
Not applicable
Not applicable
Not applicable