Osprey Medical CMW-XX Bedienungsanleitung Seite 6

Smart Syringe FCC ID: 2AHUPSS
Pressure Module FCC ID: 2AHUPPM
Classifications per IEC 60601-1 / UL 60601-1:
Degree of Protection:
Enclosure Degree of Ingress 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 Display, DyeVert Plus or DyeVert
Plus EZ Module, Smart Syringe or Pressure Module not expressly approved by
Osprey Medical 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
designed to provide 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 Display and the other equipment.

Connect the other equipment into an outlet on a circuit different from that to
which Display is connected.

Consult Osprey Medical for help.
WARNING: Portable and mobile RF communications equipment may affect the
devices. The Display should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the Display should be
observed to verify normal operation.
WARNING: Use of accessories, transducers and cables other than those
specified or provided by Osprey Medical 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 Display or disposables, including cables specified
by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
WARNING: Electromagnetic interference has been observed in testing at 385
MHz and 450 MHz causing display screen distortion or scrambling.
If performance of the system is lost or degraded due to electromagnetic
interference, the procedure may continue without contrast monitoring.
The Display and disposables have Bluetooth transceivers using short-wavelength
UHF radio waves in the ISM band from 2.4 to 2.485 GHz. The Display 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+.
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 Display 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
The Display 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 Display is intended for use by healthcare
professionals only. The Display may disrupt the operation of
nearby equipment. It may be necessary to take mitigation
measures such as re-orientating or relocating the Display or
shielding the location.
Type CF-Applied Part
IP31
Noncontinuous
th edition. These limits are
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 Compliance
level Level
Electrostatic +/- 6kV contact Pass
discharge (ESD) +/- 8kV air
IEC 61000-4-2
Electrical fast +/- 2kV for power Pass
transient/burst supply lines
IEC 61000-4-4 +/- 1kV for
input/output lines
Surge +/- 1kV line(s) to Pass
IEC 61000-4-5 line(s)
Voltage dips, <5% U (>95% dip Pass
T
short interruptions in U for 0,5 cycle)
T
and voltage
variations on 40% U (60% dip in
T
power supply U for 5 cycle)
T
input lines
IEC 61000-4-11 70% U (30% dip in
T
U for 25 cycle)
T
<5% U (>95% dip
T
in U for 5 s)
T
Power frequency 3 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
2.5 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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land 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 80 MHz, 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 Separation distance according to frequency of transmitter
maximum
output power
150 kHz to 80 MHz
of transmitter
d = 1.2√P
W
0.01 .12
0.1 .38
1 1.2
10 3.8
100 12
Electromagnetic environment -
guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the CMS
display requires continued operation
during power mains interruptions, it is
recommended that the CMS display 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 2.5 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 the compliance level in each
frequency range. b
m
80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2√P d = 2.3√P
.12 .23
.38 .73
1.2 2.3
3.8 7.3
12
8161-N Jan 2020
a
23