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DyeVert Plus Contrast Reduction System, DyeVert Plus EZ Contrast Reduction System
and DyeTect Contrast Monitoring System FCC Information
Smart Monitor FCC ID: BCG A1538
DyeVert Plus Module FCC ID: 2AHUPDV
DyeVert Plus EZ Module FCC ID: 2AHUPDV
Smart Syringe FCC ID: 2AHUPSS
Pressure Module FCC ID: 2AHUPPM
Classifications per IEC 60601-1 / UL 60601-1:
Degree of Protection:
Mode of Operation:
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
WARNING: Changes or modifications to the Smart Monitor, DyeVert Plus and DyeVert Plus EZ
Module, Smart Syringe or Pressure Module not expressly approved by Osprey Medical Inc.
could void the user's authority to operate the equipment.
ELECTROMAGNETIC INTERFERENCE PRECAUTIONS
This equipment has been tested and found to comply with the limits for a Group 1 Class B
device, pursuant to IEC/EN 60601-1-2, 4
reasonable protection against harmful interference. This equipment, if not installed and used
in accordance with the instructions, may cause harmful interference to other equipment.
However, there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to other devices, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference by
one or more of the following measures:
Reorient or relocate the other equipment.
Increase the separation between the Smart Monitor and the other equipment.
Connect the other equipment into an outlet on a circuit different from that to which Smart
Monitor is connected.
Consult Osprey Medical Inc. for help.
WARNING: Portable and mobile RF communications equipment may affect the devices. The
Smart Monitor should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the Smart Monitor should be observed to verify normal operation.
WARNING: Use of accessories, transducers and cables other than those specified or provided
by Osprey Medical, Inc. could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
WARNING: Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the Smart Monitor or disposables, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Warning: Electrostatic Discharge interference has been observed at the home button of the
Smart Monitor causing screen flicker.
If performance of the system is lost or degraded due to electromagnetic interference, the
procedure may continue without contrast monitoring.
The Smart Monitor and disposables have Bluetooth transceivers using short-wavelength UHF
radio waves in the ISM band from 2.4 to 2.485 GHz. The Smart Monitor transmits a maximum
signal strength of 1 mW (0 dBm ERP) using GSFM modulation as per IEEE 802.15.1 Bluetooth
standard and the Bluetooth SIG Working Group specification Version 4.0+.
The Smart Monitor contains Wi-Fi transceivers using short-wavelength UHF radio waves in the
ISM band from 2.4 to 2.485 GHz <100mW and 5.15-5.35/5.470-5.725 GHz <200mW and 5.725-
5.875 GHz <25mW. The Smart Monitor transmits using modulation as per IEEE 802.11.
Guidance and manufacturer's declaration – electromagnetic emissions
The system is intended for use in the electromagnetic environment specified below. The customer or the user of
the system should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions
Group 1
The Smart Monitor uses RF energy only for its internal function.
CISPR 11
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
Class B
CISPR 11
IEC 61000-3-2
Not Applicable <75W
The Smart Monitor is suitable for use in all establishments other than
domestic, and may be used in domestic establishments and those directly
connected to the public low-voltage power supply network that supplies
building used for domestic purposes, provided the following warning is
heeded:
WARNING: The Smart Monitor is intended for use by healthcare
professionals only. The Smart Monitor may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures such
as re-orientating or relocating the Smart Monitor or shielding the location.
Type CF-Applied Part
Noncontinuous
th
edition. These limits are designed to provide
Guidance and manufacturer's declaration – electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below. The customer or the user of
the system should assure that it is used in such an environment.
Immunity Test
IEC 60601 test level
Compliance
Level
Electrostatic
+/- 8kV contact
discharge (ESD)
+/- 15kV air
IEC 61000-4-2
Electrical fast
+/-
2kV
for
power
transient/burst
supply lines
IEC 61000-4-4
Surge
+/- 2kV line(s) to line(s)
IEC 61000-4-5
Voltage dips, short
<5% U
(>95% dip in U
T
T
interruptions and
for 0,5 cycle)
voltage variations on
power supply input
40% U
(60% dip in U
T
T
lines
for 5 cycle)
IEC 61000-4-11
70% U
(30% dip in U
T
T
for 25 cycle)
<5% U
(>95% dip in U
T
T
for 5 s)
Power frequency
30 A/m
(50/60 Hz) magnetic
field
IEC 61000-4-8
NOTE U
is the a.c. mains voltage prior to application of the test level
T
Guidance and manufacturer's declaration - electromagnetic immunity
The system is intended for use in the electromagnetic environment specified below. The customer or the user of
the system should assure that it is used in such an environment.
Immunity
IEC
60601
Compliance
test
test level
level
Conducted RF
3 Vrms
3 Vrms
IEC 61000-4-6
150 kHz to
80 MHz
Radiated RF
3 V/m
3 V/m
IEC 61000-4-3
80 MHz to
2.7 GHz
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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
a
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 Contrast Monitoring System
is used exceeds the applicable RF compliance level above, the Contrast Monitoring System should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the Contrast Monitoring System.
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and
the system
The system is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the system
as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
Separation distance according to frequency of transmitter
output power of
transmitter
150 kHz to 80 MHz
W
d = 1.2√P
0.01
0.12
0.1
0.38
1
1.2
10
3.8
100
12
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.
Electromagnetic environment - guidance
Pass
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Pass
Mains power quality should be that of a typical
commercial or hospital environment.
Pass
Mains power quality should be that of a typical
commercial or hospital environment.
Pass
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the Smart Monitor
requires continued
operation during power mains interruptions, it is
recommended that the Smart Monitor be
powered from an uninterruptible power supply or
battery.
Pass
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the system,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.7 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 RF transmitters, as determined
by an electromagnetic site survey,
should be less than
a
the compliance level in each frequency range.
m
80 MHz to 800 MHz
d = 1.2√P
0.12
0.38
1.2
3.8
12
8280-B
b
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