8161-L
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.
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
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6kV contact
+/- 8kV air
Pass
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2kV for power
supply lines
+/- 1kV for
input/output lines
Pass
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+/- 1kV line(s) to
line(s)
Pass
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% U
T
(>95% dip
in U
T
for 0,5 cycle)
40% U
T
(60% dip in
U
T
for 5 cycle)
70% U
T
(30% dip in
U
T
for 25 cycle)
<5% U
T
(>95% dip
in U
T
for 5 s)
Pass
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.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
Pass
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level
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
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
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
d = 1.2√P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
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,
a
should be less than the compliance level in each
frequency range.
b
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
maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.5 GHz
d = 2.3√P
0.01
.12
.12
.23
0.1
.38
.38
.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
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.
DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY
THERE IS NO WARRANTY EXPRESSED OR IMPLIED, INCLUDING WITHOUT
LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF
FITNESS FOR A PARTICULAR PURPOSE, ON THE OSPREY MEDICAL
PRODUCT(S) DESCRIBED IN THIS PUBLICATION. IN THE EVENT OF ANY
DEFECT OR NONCONFORMITY OF OR TO THIS PRODUCT(S), OSPREY
MEDICAL’S LIABILITY SHALL NOT BE IN EXCESS OF THE PURCHASE
PRICE OF THE PRODUCT(S) TO BUYER. UNDER NO CIRCUMSTANCES
SHALL OSPREY MEDICAL BE LIABLE FOR ANY DIRECT, INDIRECT OR
CONSEQUENTIAL DAMAGES BASED UPON BREACH OF WARRANTY,
BREACH OF CONTRACT, NEGLIGENCE, STRICT TORT OR ANY OTHER
THEORY ARISING OUT OF THE PURCHASE, USE OR REUSE OF THIS
PRODUCT(S). OSPREY MEDICAL NEITHER ASSUMES NOR AUTHORIZES
ANY PERSON TO ASSUME FOR IT ANY OTHER OR ADDITIONAL LIABILITY
OR RESPONSIBILITY IN CONNECTION WITH OSPREY MEDICAL
PRODUCT(S). Descriptions or specifications in Osprey Medical printed matter,
including this publication, are meant solely to generally describe the product at
the time of manufacture and do not constitute any express warranties.
Packaging Symbol Definitions
Consult
electronic
Instructions for
Use
Keep Dry
REF
Model number
Manufacturer
European
Conformity
EU Authorized
Representative
RxOnly
Prescription
Only
Serial Number
WEEE Directive
Temperature
Limit
Humidity
Limitation
Atmospheric
Pressure
Limitation
Australian Communications and Media
Authority mark
Restriction of
Hazardous
Substances
IP31
Protected against vertically falling water when the enclosure is vertical and ingress
of solid foreign objects greater than or equal to 2.5 mm (0.1 in.) diameter per IEC
60529
E485882
UL Mark for the United States for Medical – General Medical Equipment as to
Electrical Shock, Fire and Mechanical Hazards Only in Accordance with ANSI/AAMI
ES 60601-1 (2005)+AMD (2012) and UL 60601-1.
Osprey & DyeVert are trademarks of Osprey Medical Inc.
©Osprey Medical Inc. 2019. All Rights Reserved.
Osprey Medical Inc.
5600 Rowland Road, Suite 250
Minnetonka, MN 55343
USA
Customer Service:
1-855-860-7584 Fax: 1-855-883-4365
www.ospreymed.com
2797
MedPass SAS
95 bis Bd Pereire, 75017 Paris, France
Australian Sponsor
Osprey Medical, Pty
Level 13, 41 Exhibition Street
Melbourne, Victoria 3000, Australien
