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Guidance and Manufacturer's Declaration – Immunity
The ClariVein® OC is intended for use in the electromagnetic environment specified below. The
user should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
ESD
±6kV Contact
IEC 61000-4-2
±8kV Air
EFT
±2kV Mains
IEC 61000-4-4
±1kV I/Os
Surge
±1kV Differential
IEC 61000-4-5
±2kV Common
Voltage Dips/
>95% Dip for 0.5 Cycle
Dropout
60% Dip for 5 Cycles
IEC 61000-4-11
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
Power Frequency
3A/M
50/60Hz
Magnetic Field
IEC 61000-4-8
Guidance and Manufacturer's Declaration – Immunity for ME Equipment/Systems that are
NOT life supporting.
The ClariVein® OC is intended for use in the electromagnetic environment specified below. The
user should ensure that it is used in such an environment.
Immunity
IEC 60601
Compliance
Test
Test Level
Level
Radiated RF
3 V/m 80 MHz
(E1)=3V/m
IEC 61000-4-3
to 2.5 GHz
Recommended Separation Distances between portable and mobile RF Communications
equipment and the ClariVein® which is NOT Life-supporting.
The ClariVein® OC is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The user can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF Communications Equipment
and the ClariVein® OC as recommended below, according to the maximum output power of the
communications equipment.
Max Output
Separation (m) 150 to
80MHz
Power
D=(3.5/V1)(Sqrt P)
(Watts)
0.01
0.116667
0.1
0.368932
1
1.166667
10
3.689324
100
11.66667
Compliance
Electromagnetic Environment
Level
– Guidance
±6kV Contact
Floors should be wood,
±8kV Air
concrete or ceramic tile. If floors
are synthetic, the r/h should be
at least 30%
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
N/A
Mains power quality should be
that of a typical commercial or
hospital environment.
N/A
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the ClariVein® OC requires
continued operation during
power mains interruptions,
it is recommended that the
ClariVein® OC be powered
from an uninterruptible power
supply or battery.
3A/M
Power frequency magnetic
fields should be that of a typical
commercial or hospital
Electromagnetic Environment – Guidance
Portable and mobile communications
equipment should be separated from the
ClariVein® OC by no less than the distances
calculated/listed below:
D=(3.5/V1)(Sqrt P) 150 to 80 MHz
D=(3.5/E1)(Sqrt P) 80 to 800 MHz
D=(7/E1)(Sqrt P) 800 MHz to 2.5 GHz
where P is the max power in watts and D is
the recommended separation
distance in meters.
Field strengths from fixed transmitters, as
determined by an electromagnetic
site survey, should be less than the
compliance levels (E1).
Interference may occur in the vicinity of
equipment containing a transmitter.
Separation
Separation (m) 800MHz
(m) 80 to
to 2.5GHz
800MHz
D=(7/E1)(Sqrt P)
D=(3.5/E1)
(Sqrt P)
0.116667
0.233333
0.368932
0.737865
1.166667
2.333333
3.689324
7.378648
11.66667
23.33333
DEFINITIONS OF SYMBOLS
Caution - Federal Law (USA) restricts this device to sale by or on the order of a
physician.
Catalog Number
Lot Number
Consult Instructions for Use
For electronic copy scan QR code, or go to www.merit.com/ifu and enter IFU ID. For
printed copy, call U.S.A. or EU Customer Service
BF, Applied part
Do Not Re-sterilize
Single Use
Use By: YYYY-MM-DD
Manufacturer
Sterilized Using Ethylene Oxide
Keep dry
Fragile, handle with care
Do Not Use If Package is Damaged and Consult Instruction for Use
European Conformity mark
2797
Temperature Limit
Humidity Limitation
Atmospheric pressure limitation
Non-pyrogenic
Caution
Date of Manufacture: YYYY-MM-DD
Medical Device
Unique Device Identifier
Single sterile barrier system with protective packaging inside
Authorized Representative in European Community
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