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Empi EPIX VT - Description of Device Markings

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22
Description
of
Device
Markings
The
markings
on
your
Epix
VT
TENS
device
are
your
assurance
of
its
conformity
to
the
highest
applicable
standards
of
medical
equipment
safety
and
electromagnetic
compatibility.
One
or
more
of
the
following
markings
may
appear
on
your
device:
Council
Directive
93/42/EEC
Concerning
Medical Devices
(Medical
Device
Directive).
The
notified
body,
TUV
Product
Services
ID
0123,
has
granted
Empi
an
EC
Certificate
according
to
Annex
II,
Clause
3
of
Council
Directive
93/42/EEC.
CSA
C22.2
No.
125-M1984
Electromedical
equipment,
Canadian
Electrical
Code.
Part
Il:
Safety
standards
for
Electrical
Equipment
Risk
Class
2.
Transcutaneous
Electrical
Nerve
Stimulator
Also
classified
by
Underwriters
Laboratories
Inc.
in
accordance
with
ANSI/AAMI
NS4-1985
American
National
Standard
for
TENS.
Classified
by
Underwriters
Laboratories
IncĀ®
with
respect
to
electric
shock,
fire
and
mechanical
hazards
only
in
accordance
with
UL
60601-1,
and
CAN/CSA
C22.2
No.
601.1-M90.
Refer
to
ACCOMPANYING
DOCUMENTS
Type
BF
Equipment

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