Mindray BeneHeart D2, Operator'S Manual

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Defibrillator/Monitor Operator’s Manual C - 1
C
EMC and Radio Regulatory Compliance
C.1 EMC
The equipment meets the requirements of IEC 60601-1-2: 2014.
WARNING
•
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this device could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this device and result in improper operation.
•
The non-ME EQUIPMENT (e.g. ITE) that is a part of an ME SYSTEM may be disrupted by the
electromagnetic interference of nearby equipment. It may be necessary to take mitigation
measures, such as re-orienting or relocating the non-ME EQUIPMENT or shielding the location.
•
Use of this device adjacent to or stacked with other device should be avoided because it could result
in improper operation. If such use is necessary, this device and the other device should be observed
to verify that they are operating normally.
•
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 the this device, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this device
could result.
•
Other devices may affect this equipment even though they meet the requirements of CISPR.
•
When the inputted signal is below the minimum amplitude provided in technical specifications,
erroneous measurements could result.
NOTE
•
The equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided below.
•
Portable and mobile RF communications equipment may affect this equipment.
•
This equipment is intended for use in professional healthcare facility environment
,
or in home
healthcare environment such as restaurants, cafes, shops, stores, markets, schools, churches,
libraries, outdoors (streets, sidewalks, parks), domiciles (residences, homes, nursing homes), train
stations, bus stations, airports, hotels, hostels, pensions, museums, theatres. If it is used in special
environment, such as magnetic resonance imaging environment, the equipment may be disrupted
by the operation of nearby equipment.
Guidance and Declaration - Electromagnetic Emissions
The equipment is suitable for use in the electromagnetic environment specified below. The customer or the user of the
equipment should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 The equipment 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.
RF emissions CISPR 11 Class B The equipment 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.
Harmonic emissions
IEC 60601-1-2
EN 61000-3-2
Class A
Voltage fluctuations/flicker
emissions IEC 60601-1-2
EN 61000-3-3
Complies