Electromagnetic Compatibility (EMC)
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in this section. Portable and Mobile RF communications
equipment can affect Medical Electrical Equipment.
Emission Test
Compliance
RF Emissions CISPR 11
Group 1
RF Emissions CISPR 11
Class B
Harmonics IEC 61000-3-2
N/A
Flicker IEC 61000-3-3
N/A
Immunity Test
EN/IEC 60601 Test Level
ESD EN/IEC 61000-4-2
±6kV Contact, ±8kV Air
EFT EN/IEC 61000-4-4
±2kV Mains, ±1kV I/Os
±1kV Differential,
Surge EN/IEC 61000-4-5
±2kV Common
>95% Dip for 0.5 Cycle
Voltage Dips/Dropout
60% Dip for 5 Cycles
EN/IEC 61000-4-11
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
Power Frequency
50/60Hz, Magnetic Field
3 A/m
EN/IEC 61000-4-8
Immunity Test
EN/IEC 60601 Test Level
Conducted RF
3Vrms, 150kHz to 80MHz
EN/IEC 61000-4-6
Radiated RF
3Vms, 80MHz to 2.5GHz
EN/IEC 61000-4-3
The LED Light Fiber is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the LED Light Fiber can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF Communications Equipment (transmitters) and the LED Light Fiber as recommended below, according to the maximum output power of the
Max Output Power of Transmitter (Watts)
0.01
0.1
1
10
100
How Supplied
The XprESS ENT Dilation System is provided sterile and is intended for single-use only. Do not resterilize and/or
reuse, as it may result in compromised device performance and risk improper sterilization and cross-contamination.
Do not use breached or damaged packages, since the sterility and functionality of the device may be compromised.
Limited Warranty
Refer to Entellus Medical, Inc. Standard Terms and Conditions.
Guidance and Manufacturer's Declaration - Emissions
The LED Light Fiber is intended for use in the electromagnetic environments specified below.
The customer or the user of the LED Light Fiber should assure that it is used in such an environment.
Electromagnetic Environment - Guidance
The LED Light Fiber uses RF energy only for its internal function. Therefore, its emissions are very low and are not likely to cause any interference in nearby
electrical equipment.
The LED Light Fiber is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Guidance and Manufacturer's Declaration – Immunity
The LED Light Fiber is intended for use in the electromagnetic environments specified below.
The customer or the user of the LED Light Fiber should assure that it is used in such an environment.
Compliance Level
Electromagnetic Environment - Guidance
±6kV Contact,
Floors should be wood, concrete, or ceramic tile. If floors are synthetic, the RH should be at least 30%.
±8kV Air
N/A
N/A
(LED Light Fiber is powered
by internal battery)
Power frequency magnetic fields should be that of a typical commercial or hospital environment.
3 A/m
Guidance and Manufacturer's Declaration – Immunity
The LED Light Fiber is intended for use in the electromagnetic environments specified below.
The customer or the user of the LED Light Fiber should assure that it is used in such an environment.
Compliance Level
Electromagnetic Environment - Guidance
N/A
Portable and mobile RF communications equipment should be used no closer to the LED Light Fiber than the distances calculated or
listed below.
(LED Light Fiber is powered
by internal battery)
Recommended Separation Distance
3V/m (E1)
d = 1.2√P 80MHz to 800MHz
d = 2.3√P 800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter in watts and d is the recommended separation distance in meters.
Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance level (E1).
Interference may occur in the vicinity of equipment containing a transmitter.
Recommended Separation Distances between portable and mobile RF communications equipment and the LED Light Fiber
150kHz to 80MHz
d =(1.2)(√P)
N/A
(LED Light Fiber is powered by an internal battery)
Conducted RF Immunity testing does not apply,
resulting in no separation data from 150kHz
to 80MHz.
communications equipment.
Separation distance according to frequency of transmitter (m)
80MHz to 800MHz
d =(1.2)(√P)
0.12
0.38
1.2
3.8
12
6
800MHz to 2.5GHz
d =(2.3)(√P)
0.23
0.73
2.3
7.3
23