Integra Codman ICP Express, Manual

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EN – ENGLISH
9
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of ICP Express Monitor 82-6634 and its accessories Otherwise, degradation of the performance of this equipment could
result
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.
Reference Table 201 IEC 60601-1-2
Reference Table 202 IEC 60601-1-2
1)
Electrical Fast Transient/Burst
disturbances greater than ±0.5 kV on the AC Mains can 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 must be notified for confirmation.
In the event that the disturbance continues, the user is advised to connect the ICP EXPRESS Monitor to a different AC Mains outlet.
Table 1
Manufacturer’s Declaration – Emissions All Equipment and Systems
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 must assure that it is used in such an environment.
Emission Test Compliance Electromagnetic Environment
RF Emissions CISPR 11 Group 1, Class B 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.
Harmonic Emissions
IEC 61000-3-2
Class A 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.
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Complies
Table 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 must 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
+/- 8 kV contact
+/- 2 kV, +/- 4 kV,
+/- 8 kV, - +/- 15 kV air
+/- 8 kV contact
+/- 2 kV, +/- 4 kV,
+/- 8 kV, - +/- 15 kV air
Floors must be wood, concrete or ceramic tile.
If floors are covered with synthetic materials, the relative humidity must be
at least 30%.
Electrical Fast
Transient/burst
IEC 61000-4-4
±2 kV on AC Mains
±1 kV I/Os
±2 kV on AC Mains
±1 kV I/Os
±0.5 kV Mains @
100/120 V, 60 Hz
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. Integra has provided sufficient justification
to disregard this issue (see note 1 below). Mains power quality must be that
of a typical commercial or hospital environment.
See Note1
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality must 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
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % UT; 1 cycle at 0°
70 % UT; 25/30 cycles 0°
0 % UT; for 5 seconds
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % UT; 1 cycle at 0°
70 % UT; 25/30 cycles 0°
0 % UT; for 5 seconds
Mains power quality must 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
(50/60 Hz) Magnetic Field IEC
61000-4-8
30 A/m 30 A/m Power frequency magnetic fields must be that of a typical location in a
typical commercial or hospital environment.
UT is the AC mains voltage prior to the application of the test level