ZOLL CMCT Monitoring System Instructions For Use Manual page 22

1:2005/(R)2012
Type BF applied part
and A1:2012,
C1:2009/(R)201
2 and
A2:2010/(R)201
2, Medical
Ingress protection
electrical
equipment –
Part 1: General
requirements
Ingress protection
for basic safety
and essential
performance
Direct current
No-ionizing radiation
ASTM F2503-13, MR Unsafe
Standard
practice for
marking
medical devices
and other items
for safety in the
magnetic
resonance
environment
CMCT Monitoring System
Instructions for Use
#19 (Table D.1)
#2 (Table D.3)
#2 (Table D.3)
#5 (Table D.1)
Figure 9
Device intended to deliver
electrophysiological signal to or
from the patient.
Indicates that Sensor is protected
from light dust and against the
effects of temporary immersion in
water.
Indicates that the Gateway is
protected against solid foreign
objects of 12.5mm or greater, and
against vertically falling water
drops.
Direct current.
Emits non-ionizing radiation
Indicates that the device may cause
unacceptable risks to the patients,
medical staff or other persons
within the MR environment. The
device should be removed prior to
any MR scanning procedure.
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