Section 6: Specifications - 3M Ranger 145 Manuel D'utilisation

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Keep dry
Manufacturer
Maximum safe working
load
Medical Device
Protective earth; protective
ground
Pushing prohibited
Recycle electronic
equipment
Rx Only
Serial number
UL Classified
Unique device identifier

Section 6: Specifications

Guidance and manufacturer's declaration – electromagnetic emissions
The model 145 is intended for use in the electromagnetic environment specified below� The customer or the user of the model 145 should assure that it is used
in such an environment�
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/Flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The model 145 is intended for use in the electromagnetic environment specified below� The customer or the user of the model 145 should assure that it is used
in such an environment�
Immunity Test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
Power frequency (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
Indicates a medical device that needs to be protected from moisture. Source: ISO 15223, 5.3.4
Indicates the medical device manufacturer as defined in EU Directives 90/385/EEC, 93/42/ EEC and 98/79/
EC. Source: ISO 15223, 5.1.1
Indicates the maximum safe working load in less than the number reported.
Indicates the item is a medical device
To identify any terminal which is intended for connection to an external conductor for protection against electric
shock in case of fault, or the terminal of a protective earth (ground) electrode. Source: IEC 60417-5019
Indicates the device should not be pushed. Source: ISO 7010-P017
DO NOT throw this unit into a municipal trash bin when this unit has reached the end of its lifetime. Please
recycle. Source: Directive 2012/19/EC on waste electrical and electronic equipment (WEEE)
Indicates that U.S. Federal Law restricts this device to sale by or on the order of physician. 21 Code of Federal
Regulations (CFR) sec. 801.109(b)(1).
Indicates the manufacturer's serial number so that a specific medical device can be identified. Source: ISO 15223, 5.1 .7
Indicates product was evaluated and Listed by UL for the USA and Canada.
Indicates bar code to scan product information into patient electronic health record
Compliance
Group 1
Class B
Class A
Complies
IEC 60601 test level
Compliance level
±8 kV contact
±8 kV contact
±15 kV air
±15 kV air
±2 kV power lines
±2 kV power lines
±1 kV line to line
±1 kV line to line
±2 kV line to gnd
±2 kV line to gnd
<5% U
<5% U
T
(>95% dip in U
)
(>95% dip in U
T
for 0,5 cycle
for 0,5 cycle
40% U
40% U
T
(60% dip in U
)
(60% dip in U
T
for 6 cycles
for 6 cycles
70% U
70% U
T
(30% dip in U
)
(30% dip in U
T
for 30 cycles
for 30 cycles
<5% U
<5% U
T
(>95% dip in U
)
(>95% dip in U
T
for 5 sec
for 5 sec
3 A/m
3 A/m
Electromagnetic environment - guidance
The model 145 uses RF energy only for its internal function� Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic equipment�
The model 145 is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage power supply
network that supplies buildings used for domestic purposes�
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
T
)
or hospital environment. If the user of the model 145 requires
T
continued operation during power mains interruptions, it
is recommended that the model 145 be powered from an
T
uninterruptible power supply or a battery.
)
T
T
)
T
T
)
T
Power frequency magnetic fields should be at levels characteristic
of a typical location in a typical commercial or hospital environment.
9

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