Electromagnetic Compatibility Tables; Guidance And Manufacturer's Declaration - Electromagnetic Emissions; Guidance And Manufacturer's Declaration - Electromagnetic Interference Immunity - NDS Zerowire G2 Instrucciones

7

Electromagnetic Compatibility Tables

All medical electronic devices must conform to the requirements of IEC 60601-1-2. Precautions, adherences to
en
the Electromagnetic Compatibility (EMC) guideline information provided in this manual and verification of all
medical devices in simultaneous operation are required to ensure the electromagnetic compatibility and co-
existence of all other medical devices prior to a surgical procedure.
The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this
equipment might not offer adequate protection to radio-frequency communication services. The user might
need to take mitigation measures, such as relocating or re-orienting the equipment.
The following EMC tables are provided for your reference:
7.1

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

The product is intended for use in an environment as described below. The user/operator of the product
should make sure the device is operated within such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
7.2

Guidance and Manufacturer's Declaration - Electromagnetic Interference Immunity

This product is intended for use in the electromagnetic environment specified below. The customer or the
user of the product should assure that it is used in such an environment.
Immunity Test
Electrostatic discharge (ESD) IEC 61000-4-2
Radiated RF field IEC 61000-4-3
Proximity fields from wireless transmitters
IEC 61000-4-3
34 | Electromagnetic Compatibility Tables
Compliance
Group 1
Class B
Class A
Complies
Electromagnetic environment - guidance
The product uses RF energy solely for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
The product is suitable for use in all establish-
ments, other than public establishments and
those directly connected to the public mains net-
work that supplies buildings used for public pur-
poses.
Immunity Test
± 2, ± 4, ± 6, ± 8 kV contract discharge
± 2, ± 4, ± 6, ± 8, ± 15 kV air discharge
3 V/m
80 MHz - 2.7 GHz
80 % AM 1 kHz
80 MHz to 2.7 GHz. 3 V/m
Spot Tests: 385 MHz. at 27 V/m;
(710, 745, 780, 5240, 5500, 5785) MHz at 9 V/m;
(450, 810, 870,930, 1720, 1845, 1970, 2450) MHz at
28 V/m