Osprey Medical DyeVert Power XT Instrucciones De Uso página 4

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 no AC power
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.
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 Not applicable No mains power.
transient/burst supply lines
IEC 61000-4-4
Surge +/- 2kV line(s) to line(s) Not applicable No mains power.
IEC 61000-4-5
Voltage dips, short <5% U (>95% dip in U Not applicable No mains power.
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 Not applicable no
cables
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.
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 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.
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 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, a should be less than
b
the compliance level in each frequency range.
Rated maximum Separation distance according to frequency of transmitter
output power of
transmitter
80 MHz to 800 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.
Packaging Symbol Definitions
Expiration Date
YYYY-MM. Use
Manufacturer
by last day of
month (MM).
Consult
electronic
Keep Dry
Instructions for
Use
European
Single Use
Conformity
Do Not Use if
Prescription
RxOnly Package is
Only
Damaged
Consult instructions
for use for
Medical Device
important
information
Power XT Module
MR Unsafe
Smart Collection
WEEE Directive
Bag
Protected against vertically falling water when the enclosure is tilted up to 15° from
IP32
vertical and ingress of solid foreign objects greater than or equal to 2.5 mm (0.1 in.)
diameter per IEC 60529
Osprey Medical Inc.
5600 Rowland Road, Suite 250
Minnetonka, MN 55343
USA
Customer Service Toll-Free:
( 1-855-860-7584 Fax: 1-855-883-4365
customerservice@ospreymed.com
www.ospreymed.com
Osprey & DyeVert are trademarks of Osprey Medical Inc
©Osprey Medical, Inc. 2020. All Rights Reserved.
DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY
THERE IS NO WARRANTY EXPRESS 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.
m
800 MHz to 2700 MHz
d = 2.3√P
0.23
0.73
2.3
7.3
23
Sterilized by
STERILE │EO
ethylene oxide
REF
Model number
LOT
Lot Number
European
EC │REP Community
Authorized
Representative
Identification of
Sterile Barrier
Temperature
Limit
Restriction of
Hazardous
Substances
EN IEC 60601-1
applied part Type
CF Defibrillation-
proof
2797 0344
MedPass SAS
95 bis Bd Pereire, 75017 Paris, France
Australian Sponsor
Osprey Medical, Pty
Level 13, 41 Exhibition Street
Melbourne, Victoria 3000, Australia
8300-E Jan 2021