Tabla de contenido
Publicidad
Parameter
Electrical Conformity
Electrical shock protection - Classification
Electrical shock protection - Degree
Product Life
Applied Part
Separation from power mains
EMC Statement
Important information regarding Electromagnetic Compatibility (EMC)
With the increased number of electronic devices such as PC's and mobile (cellular) telephones,
medical devices in use may be susceptible to electromagnetic interference from other devices.
Electromagnetic interference may result in incorrect operation of the medical device and
create a potentially unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim
to prevent unsafe product situations, the IEC 60601-1-2 standard has been implemented. This
standard defines the levels of immunity to electromagnetic interferences as well as maximum
levels of electromagnetic emissions for medical devices.
The SCOUT System conforms to this IEC60601-1-2:2014 standard for both immunity and
emissions.
Nevertheless, special precautions need to be observed:
• The use of accessories and cables other than those specified by Merit Medical, may result in
increased emission or decreased immunity of the device.
• The medical devices should not be used adjacent to or stacked with other equipment. In case
adjacent or stacked use is necessary, the medical device should be observed to verify normal
operation in the configuration in which it will be used.
Refer to further guidance below regarding the EMC environment in which the device should
be used.
Electromagnetic Compliance (EMC) Tables
Guidance and manufacturer's declaration - electromagnetic emissions
The SCOUT System is intended for use in the electromagnetic environment specified
below. The customer or user of the SCOUT System should assure that it is used in such an
environment.
Emissions test
RF emissions
Group 1
CISPR 11
Specification
This medical equipment has passed all
required testing for electric shock, fire and
mechanical hazards in accordance with
UL60601-1, IEC/EN 60601-1
Class I
Type BF Equipment
The Console is a non-sterile, durable good.
The product warranty is for a one-year time
period consistent with use described in this
manual.
The Handpiece is the patient applied part
Power switch on rear panel provides full
separation from power mains
Compliance
Electromagnetic
environment - guidance
T h e S CO U T Sy s t e m u s e s
ver y low power RF energy
for its function. Therefore,
its RF emissions are very low
and are not likely to cause
any interference in nearby
electronic equipment.
Guidance and manufacturer's declaration - electromagnetic emissions
The SCOUT System is intended for use in the electromagnetic environment specified
below. The customer or user of the SCOUT System should assure that it is used in such an
environment.
Emissions test
RF emissions
Class A
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/flicker
Complies
emissions IEC 61000-3-2
Guidance and manufacturer's declaration - electromagnetic immunity
The SCOUT System is intended for use in the electromagnetic environment specified
below. The customer or user of the SCOUT System should assure that it is used in such an
environment.
Immunity Test
IEC 60601 Test
Level
E l e c t r o s t a t i c
±8 kV contact
Discharge (ESD)
IEC 61000-4-2
±15 kV air
E l e c t r i c a l f a s t
±2 kV for power
transient/burst
supply lines
IEC 61000-4-4
±1 kV for input /
output lines
Surge
±1 k V l i n e (s) t o
line(s)
IEC 61000-4-5
± 2 k V l i n e (s) t o
earth
<5 % U T
V o l t a g e
d i p s ,
s h o r t
(>95 % dip in
interruptions and
U T) for 0.5 cycle
voltage variations
on power supply
40 % U T
input lines.
(60 % dip in U T)
for 5 cycles
IEC 61000-4-11
70 % U T
(30 % dip in U T)
for 25 cycles
<5 % U T
(>95 % dip in
U T) for 5 sec
Power frequency
3 A/m
( 5 0 / 6 0
H z )
magnetic field
IEC 61000-4-8
U T is the a.c. mains voltage prior to application of the test level.
NOTE
Guidance and manufacturer's declaration - electromagnetic immunity
The SCOUT System is intended for use in the electromagnetic environment specified below.
The customer or the user of the SCOUT System should assure that it is used in such an
environment.
*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.
Immunity Test
I E C 6 0 6 01 Te s t
Level
Compliance
Electromagnetic
environment - guidance
The SCOUT System is suitable
for use in all establishments
other than domestic, and
may be used in domestic
establishments and those
direc tly connec ted to the
public low-voltage power
supply network that supplies
buildings used for domestic
p u r p o s e s , p r o v i d e d t h e
following warning is heeded:
WARNING: This equipment/
system is intended for use
by healthcare professionals
only. This equipment/system
may cause radio interference
or may disrupt op eration
o f n e a r b y e q u i p m e n t . I t
may be necessar y to take
mitigation measures, such as
re-orienting or relocating the
SCOUT system or shielding the
location.
Compliance Level
Electromagnetic
environment - guidance
±8 kV contact
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
±15 kV air
relative humidity should
be at least 30 %.
± 2 k V f o r p owe r
M a i n s p o w e r q u a l i t y
supply lines
should be that of a typical
commercial or hospital
environment.
±1 k V f o r inp u t /
output lines
±1 k V l i n e ( s) t o
M a i n s p o w e r q u a l i t y
line(s)
should be that of a typical
commercial or hospital
environment.
± 2 k V l i n e ( s) t o
earth
<5 % U T
M a i n s p o w e r q u a l i t y
should be that of a typical
(>95 % dip in
U T) for 0.5 cycle
commercial or hospital
environment. If the user
o f t h e S CO U T Sy s t e m
40 % U T
r e q u i r e s c o n t i n u e d
(60 % dip in U T)
operation during power
for 5 cycles
mains interruptions, it is
required that the SCOUT
70 % U T
System be powered from
(30 % dip in U T)
an uninterruptible power
for 25 cycles
supply or a battery.
<5 % U T
(>95 % dip in
U T) for 5 sec
3 A/m
P o w e r
magnetic fields should be
at levels characteristic of a
typical location in a typical
commercial or hospital
environment.
Compliance Level
E l e c t r o m a g n e t i c
environment - guidance
f r e q u e n c y
Publicidad
Tabla de contenido
