Codman ICP EXPRESS Manual De Instrucciones página 11

CODFR06058xx01v10.qxd 3/8/07
Appendix A – Tables
Note: The EMC tables and other guidelines that are included in this Instruction Manual provide information to the customer or user that is essential in
determining the suitability of the Equipment or System for the Electromagnetic Environment of use, and in managing the Electromagnetic Environment of
use to permit the Equipment or System to perform its intended use without disturbing other Equipment and Systems or non-medical electrical equipment.
The Model 82-6634 ICP EXPRESS Monitor is intended for use in the electromagnetic environment specified below. The customer or user of
the Model 82-6634 ICP EXPRESS Monitor should assure that it is used in such an environment.
Emission Test
RF Emissions CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Reference Table 201 EN 60601-1-2
Guidance and Manufacturer's Declaration Regarding Electromagnetic Immunity
The Model 82-6634 ICP EXPRESS Monitor is intended for use in the electromagnetic environment specified below. The customer or user of
the Model 82-6634 ICP EXPRESS Monitor 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
U T is the AC mains voltage prior to the application of the test level
Reference Table 202 EN 60601-1-2
1) Electrical Fast Transient/Burst disturbances greater than ±0.5 kV on the AC Mains may result in erroneous displayed numeric ICP values. In this case,
disturbances that are clearly not physiological in origin will be visible on the ICP waveform displayed by the connected patient monitor. The abnormal
numeric values may not reflect an accurate account of the treatment and a trained consultant should be notified for confirmation.
In the event that the disturbance continues, the user is advised to connect the ICP EXPRESS to a different AC Mains outlet.
5:05 PM Page 11
Manufacturer's Declaration – Emissions All Equipment and Systems
Compliance
Group 1, Class B
Class A
Complies
IEC 60601 Test Level Compliance Level
±6 kV contact ±6 kV contact
±8 kV air ±8 kV air
±2 kV on AC Mains ±2 kV on AC Mains
±1 kV I/Os ±1 kV I/Os
±0.5 kV Mains @
100/120 V, 60 Hz
±1 kV differential mode ±1 kV differential mode
±2 kV common mode ±2 kV common mode
>95% dip in U T >95% dip in U T
for 0.5 cycle for 0.5 cycle
60% dip in U T 60% dip in U T
for 5 cycles for 5 cycles
30% dip in U T 30% dip in U T
for 25 cycles for 25 cycles
<5% U T <5% U T
>95% dip in U T >95% dip in U T
for 5 seconds for 5 seconds
3 A/m 3 A/m
Table 1
Electromagnetic Environment
The Model 82-6634 ICP EXPRESS Monitor 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 82-6634 ICP EXPRESS Monitor is suitable for use in all
establishments, including domestic and those directly connected to the
public low voltage power supply network that supplies buildings used
for domestic purposes.
Table 2
Electromagnetic Environment Guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic materials, the relative
humidity should be at least 30%.
During EFT testing at 100–120 VAC, 60 Hz the pressure level
went out of specification with a deviation of >3 mmHg when
a ±1.0 kV disturbance was applied to all line combinations.
Codman has provided sufficient justification to disregard this
issue (see note 1 below). Mains power quality should be that
of a typical commercial or hospital environment. See Note1.
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 uses of the Model 82-6634
ICP EXPRESS Monitor requires continued operation during
power mains interruptions, it is recommended that the
Model 82-6634 ICP EXPRESS Monitor be powered from
an uninterruptible power supply or a battery.
Power frequency magnetic fields should be that of a typical
location in a typical commercial or hospital environment.
11