21 CFR Part
801.109(b)(1)
Labeling-Prescription devices.
Prescription only
Indicates the product is
authorized for sale by or
on the order of a licensed
healthcare practitioner.
UL Listing
N/A
N/A
Nationally Recognized
Testing Laboratories
(NRTL) certifications
INMETRO in
conjunction
with UL for
Latin America
InMetro and UL marking of
conformity
MEDICAL - Gen-
eral Medical
Equipment as to
electrical shock,
fire and mech-
anical hazards only
in accordance
with:
ANSI/AAMI
ES60601-1:2005/
(R)2012
IEC 60601-1-6
CAN/CSA-C22.2
No. 60601-1:14
CAN/CSA-C22.2
No. 60601-1-6
INMETRO in conjunction
with the Mark of the
National Institute of Met-
rology, Standardization
and Industrial Quality in
Brazil
China RoHS 2
Marking
N/A
N/A
Restriction of 6 hazardous
substances for electronic
and electrical products
sold in the People’s
Republic of China
11.2
Warnings, cautions, and notes
11.2.1
Connector warnings
Warning
•
Never mix connections between the Direct Connectors & Isolated Connectors
Direct connectors
•
All connectors within the red frame are connected directly to patient transducers.
Madsen A450
89
11 Standards and Safety
