Abbott MER3700, Руководство пользователя

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electromagnetic compatibility (EMC) and should be used in accordance with the information
provided in this manual.
The Merlin 2 PCS and the Merlin Antenna comply with the requirements of the EMC international
standard IEC 60601-1-2 when used with the cables listed in the Accessories table (page 30).
The Merlin 2 PCS and the Merlin Antenna are intended for use in the electromagnetic
environment specified in the following tables. The user should ensure that they are used in such
an environment.
CAUTION: The Merlin 2 PCS and the Merlin Antenna are intended for use only by
healthcare professionals who must comply with the limits for medical devices
contained in IEC/EN 60601-1-2.
However, the Merlin 2 PCS and the Merlin Antenna may cause radio interference or
may disrupt the operation of nearby equipment. It may be necessary to mitigate this
effect by reorienting or relocating the receiving device or shielding the location.
Table 3. Guidance and manufacturer's declaration — electromagnetic emissions
Test Compliance Electromagnetic Environment — Guidance
RF Emission
CISPR 11 Group 1 The Merlin™ 2 PCS and the Merlin Antenna use RF
energy only for its internal function. Therefore, the RF
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
Class A The Merlin 2 PCS and the Merlin Antenna are suitable
for use in all establishments other than domestic and
those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A The Merlin 2 PCS and the Merlin Antenna are suitable
for use in all establishments other than 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 4. Guidance and manufacturer's declaration — electromagnetic immunity
Test IEC 60601 Test Level (Actual
Level)
4
Electromagnetic Environment —
Guidance
Electrostatic Discharge
(ESD) IEC 61000-4-2 ±8 kV contact
(±8 kV contact)
±15 kV air
(±15 kV air) Floors should be wood, concrete, or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
4 Figures in parentheses are the immunity compliance levels for each test.