Bioflex 120 Manual De Instrucciones página 19

Treatment Array
Heat Warning
It is normal for the Treatment Array surface to
get warm after extended use.
In the event that the Treatment Array gets hot,
the system will pause until the temperature
has dropped. The Treatment Array needs to
be cooled for at least 15 minutes before it is
used again.
CAUTIONSURFACES
MAYGETHOT
General Warning Symbol
CE Mark
The CE mark is a registered trademark of the
European Community.
0459
TUV Mark
TUV mark denotes compliance to listed
standards.
Manufacturer: Meditech International Inc.
411 Horner Avenue Unit 1, Toronto, ON
M8W 4W3 Canada
Meditech's EU Auathorized Representative
Meditech's UK Auathorized Representative
36
MN 421.012 Rev 3
Electromagnetic Compatibility
(EMC)
Medical Electrical Equipment needs special precautions regarding EMC
and needs to be installed and put into service according to the EMC
information provided in this manual
Portable and mobile RF communications equipment can affect Medical
Electrical Equipment
Warning: The BIOFLEX Personal Therapy System is intended for use by
®
general public. It is suitable for use in all establishments including domestic
establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes
including hospitals except for near active HF surgical equipment and the
RF shielded room of an ME system for Magnetic Resonance Imaging, (MRI)
where the intensity of EM disturbances is high. This system may cause
radio interference or may disrupt the operation of nearby equipment.
It may be necessary to take mitigation measures, such as reorienting or
relocating the equipment or shielding the location.
Table 1
BIOFLEX Personal System List of Cables, Transducers
®
and Accessories
Cable Length
Power cord, 1.83 m
CT402.019
Warning: the use of accessories and cables other than those specified in
this manual, with the exception of accessories and cables qualified and
sold by Meditech International Inc. may result in increased emissions or
decreased immunity of the equipment and may cause the system to be
non-compliant with the requirements of IEC 60601-1-2:2014
Connected From Connected to
Power Supply Power Outlet
MN 421.012 Rev 3
37