Universal XactTrace
®
User Instructions
2
Essential Performance
In normal operational mode, essential performance is defined as the following:
•
Output signals may contain electrical artifacts which are distinguishable to a
medical professional and must self-recover after test. The signal can
hesitate or freeze under immunity testing, as long as it recovers after
stimulus is removed, with no net change in the signal.
Description of Symbols
Symbol
Standard
Reference
Standard Title of
Symbol
Symbol Title
as per
Referenced
Standard
Explanation
ISO 15223-1
Symbol 5.4.4
Medical devices
—
Symbols to be used
with information to
be supplied by the
manufacturer
— Part
1: General
requirements
Caution
Indicates the need for
the user to consult the
instructions for use for
important cautionary
information such as
warnings and
precautions that
cannot, for a variety of
reasons, be presented
on the medical device
itself.
IEC 60601-1
Table D.1
#10
Medical electrical
equipment
— Part 1:
General
requirements for
basic safety and
essential
performance.
N/A
N/A
Note
A note that contains
important
supplemental
information
IEC 60601-1
Table D.2
#10
Medical electrical
equipment
– Part 1:
General
requirements for
basic safety and
essential
performance.
Follow
Instructions
for Use
Refer to instruction
manual/Booklet.
NOTE on ME
EQUIPMENT
“Follow Instructions for
use”.
ISO 15223-1
Symbol 5.4.3
Medical devices
—
Symbols to be used
with information to
be supplied by the
manufacturer
— Part
1: General
requirements
Consult
Instruction
for Use
Indicates an
instruction to consult
an electronic
instruction for use
ISO 15223-1
Symbol 5.1.3
Medical devices
—
Symbols to be used
with information to be
supplied by the
manufacturer
— Part
1: General
requirements
Date of
manufacture
Indicates the date when
the medical device was
manufactured.
