natus ALGO 3i User Manual

ALGO
®
3i Newborn Hearing Screener IFU 024913 RevD Revision Date 08/05/2020
46
Appendix A: Electromagnetic Compatibility (EMC)
Portable and mobile RF communications equipment can affect the ALGO 3i. Install and operate the device
according to the EMC information presented in this section.
ALGO 3i is suitable in hospital environments except for near active HF surgical equipment and RF shielded
rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high.
ALGO 3i meets Class B (CISPR Classification) while used in the screening mode and Class A when used in
conjunction with the charger for charging the battery or for data management, which allows use of ALGO 3i
under jurisdiction of a health care professional.
ALGO 3i has no essential performance as related to IEC 60601-1.
WARNING 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 instrument and the other equipment
should be observed to verify that they are operating normally.
WARNING Use of accessories, transducers and cables other than those specified or provided by Natus
Medical Incorporated could result in increased electromagnetic EMISSIONS or decreased electromagnetic
IMMUNITY of the equipment and result in improper operation.
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 this instrument, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Declaration of compliance for IEC 60601-1-2: Ed. 4.0 (2014)
The ALGO 3i device is intended for use in the electromagnetic environment specified below. The customer or the
user of the ALGO 3i device should assure that it is used in such an environment.
Table 1 - Electromagnetic emissions
Emissions Test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The ALGO 3i 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 environment.
RF emissions
CISPR 11
Class B
The ALGO 3i 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, provided the following warning is heeded:
This equipment/system is intended for
use by healthcare professionals only. This equipment/
system may cause radio interference or may disrupt
the operation of nearby equipment. It may be
necessary to take mitigation measures, such as
reorienting or relocating the equipment or shielding
the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies

natus ALGO 3i Specifications

General

Brand	natus
Model	ALGO 3i
Category	Medical Equipment
Language	English