Medtronic 301-000-000 Instructions for Use

301-000-000

340-000-000

McGRATHTM MAC

Video Laryngoscope

Addendum

This addendum provides the appropriate specication tables for the next-generation McGRATH™ MAC video laryngoscope per
IEC 60601-1-2: 2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests.

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

Table 1 – Electromagnetic Emissions

The device is intended for use in the electromagnetic
environment specied below. The operator of the device
should assure that it is used in such an environment.

Emissions Test Compliance Level

Radiated RF emissions CISPR
11:2009 +A1:2010

Radiated RF emissions
ISO 7137:1995

Table 2 – Electromagnetic Immunity

The device is intended for use in the electromagnetic
environment specied below. The operator of the device
should assure that it is used in such an environment.

Immunity Test Compliance Level

Electrostatic Discharges
IEC 61000-4-2:2008

Radiated RF EM Fields
IEC 61000-4-3:2006 +A1:2007
+A2:2010

Radiated RF EM Fields and
Proximity Wireless Fields
IEC 61000-4-3:2006 +A1:2007
+A2:2010

Rated Power-frequency
Magnetic Field
IEC 61000-4-8:2009

Group 1 Class B

100MHz – 6GHz

±8kV contact
±2kV, ±4kV, ±8kV, ±15kV air

10V/m Modulation of 80%
AM at 1kHz.
Frequency 80MHz –
2700MHz

Refer to Table 3

30A/m. Frequency 50Hz
and 60Hz

Table 3 – Proximity elds from RF wireless communications
equipment

Test Frequency
(MHz)

385 18 Hz 27

450 18 Hz 28

710
745
780

810
870
930

1720
1845
1970

2450 217 Hz 28

5240
5500
5785

The following tests are not applicable as the device is battery
powered:

• Terminal disturbance voltages CISPR 11:2009+A1:2010

• AC-Mains Harmonics IEC 61000-3-2:2005 +A1:2008+A2:2009

• AC-Mains uctuations and icker IEC 61000-3-3:2013

• Electrical fast transient / bursts IEC 61000-4-4:2012

• Surges IEC 61000-4-5:2005

• Conducted disturbances induced by RF elds IEC 61000-4­6:2013

• Voltage dips IEC 61000-4-11:2004

• Voltage interruptions IEC 61000-4-11:2004

Modulation Complies with

IMMUNITY Level (V/m)

217 Hz 9

18 Hz 28

217 Hz 28

217 Hz 9

Consult

instructions

for use

Part No. PT00147312 Rev A 2021-06

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