n
MedWatch Online Voluntary Reporting Form:
http://www.accessdata.fda.gov/scripts/medwatch/index.cfm?
n
Consumer Reporting Form FDA 3500B:
http://www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Forms/UCM349464.pdf
Follow the instructions on the form to either fax or mail it in for
submission. For help filling out the form, see MedWatchLearn:
http://www.accessdata.fda.gov/scripts/MedWatchLearn/
n
Call FDA at 1-800-FDA-1088 to report by telephone.
2.7 Symbols on the miha bodytec m.ove
2.7.1 Symbols on device
Symbol
Standard Reference
Standard Title
Symbol Title
Explanatory Text
ISO 7010 Second Edi-
tion 2011-06-01, P007
Graphical Symbols –
Safety Colours And
Safety Signs – Reg-
istered Safety Signs
[Including AMEND-
MENT 1 (2012)
Through AMEND-
MENT 7 (2016)]
Not for persons
with pacemakers
or implanted
defibrillators
The device must never
be used by persons
with cardiac pace-
makers or other active
medical implants. In
this connection, also
observe the contraindi-
cations.
ES60601-1:2005/
(R)2012 And A1:2012,
Table D.2, Symbol 10
Medical electrical
equipment – Part 1:
General require-
ments for basic
safety and essential
performance.
Follow instruc-
tions for use
Read and observe this
manual carefully before
start-up and use.
ISO 7010 Second Edi-
tion 2011-06-01, P019
Graphical Symbols –
Safety Colours And
Safety Signs – Reg-
istered Safety Signs
[Including AMEND-
MENT 1 (2012)
Through AMEND-
MENT 7 (2016)]
No stepping on
surface
Do not step on the sur-
faces of the device or
its accesories at any
time.
Safety
2021-07-28
miha-bodytec m.ove EMS training device
30