ZOLL Medical I Ltd. U3CMCT Benutzerhandbuch

CMCT Monitoring System
Instructions for Use

Page 22 of 31

1:2005/(R)2012

and A1:2012,

C1:2009/(R)201

2 and

A2:2010/(R)201

2, Medical

electrical

equipment –

Part 1: General

requirements

for basic safety

and essential

performance

Type BF applied part

#19 (Table D.1)

Device intended to deliver

electrophysiological signal to or

from the patient.

Ingress protection

#2 (Table D.3)

Indicates that Sensor is protected

from light dust and against the

effects of temporary immersion in

water.

Ingress protection

#2 (Table D.3)

Indicates that the Gateway is

protected against solid foreign

objects of 12.5mm or greater, and

against vertically falling water

drops.

Direct current

#5 (Table D.1)

Direct current.

No-ionizing radiation

Emits non-ionizing radiation

ASTM F2503-13,

Standard

practice for

marking

medical devices

and other items

for safety in the

magnetic

resonance

environment

MR Unsafe

Figure 9

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.