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Operator’s Manual F - 1

EMC Guidance and

Manufacturer’s Declaration

The system complies with the EMC standard IEC 60601-1-2: 2014.

Intended Environments: HOME HEALTHCARE ENVIRONMENT (except for air charge module

and the probe

P7-3Ts/P8-3Ts/P8-2Ts/LAP13-4Cs).

Intended Environments: Professional healthcare facility environment (including air charge

module and the probe

P7-3Ts/P8-3Ts/P8-2Ts/LAP13-4Cs)

WARNING

• The use of unapproved accessories may diminish system per-formance.

• Use of components, accessories, probes, and cables other than those

specified may result in increased emission or decreased immunity of

system.

• Operation of system, in the case that the patient physiological signal is

lower than the minimum amplitude or value specified in the product

specifications, results may not be obtained (results can be obtained when

the HR is in the range of 30-250 bmp or when the QRS wave amplitude is

between 0.5-5 mV.)

• Use of this equipment adjacent to or stacked with other equipment should

be avoided because it could result in improper operation. If such use is

necessary, this equipment and the other equipment should be observed to

verify that they are operating normally.

• Use of accessories, transducers and cables other than those specified or

provided by the manufacturer of this equipment could result in increased

electromagnetic emissions or de-creased electromagnetic immunity of this

equipment and result in improper operation.

• 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 TEX20, including cables specified by the

manufacturer. Otherwise, degradation of the performance of this equipment

could result.

NOTE:

This equipment has been tested and found to comply with the limits for a Class B digital device,

pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection

against harmful interference in a residential installation. This equipment generates, uses and can

radiate radio frequency energy and, if not installed and used in accordance with the instructions,

may cause harmful interference to radio communications. However, there is no guarantee that

interference will not occur in a particular installation. If this equipment does cause harmful

Mindray TEX20 Operator's Manual

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