Instructions For Use
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© 2018 Endotronix Inc.
100474-00 Rev 1
Device that needs to be protected from moisture.
Federal Communication Commission Number
Device that can be broken or damaged if not
handled carefully.
Device manufacturer.
Date when the device was manufactured.
Device should be attached to direct current source.
Device should be attached to alternating current
source.
The myCordella Patient Reader and Calibration
Equipment operate using lithium-ion batteries.
Lithium-ion batteries should not be crushed or
burned.
Equipment meeting the safety requirements
specified for Class II equipment according to IEC
61140.
Type BF applied part complying with IEC 60601-1.
IP
N
1
N
2
Manufacturer-determined degree of particle and
water ingress protection, where...
N1 = degree of protection from particulates (scale of
0-6); and
N2 = degree of protection from water (scale of 0-8)
IP21
Protected against solid foreign objects of 12.5 mm
and greater, and against the effects of dripping
water.
IP22
Protected against solid foreign objects of 12.5 mm
and greater, and against the effects of dripping
water when tilted at 15°.
IP42
Protected against solid foreign objects of 1.0 mm or
greater, and against the effects of dripping water
when tilted at 15°.
IP54
Limited protection against dust ingress, and against
splash water from any direction.
Device has been demonstrated to pose no known
hazards in a specified MRI environment with
specified conditions of use.
General warning.
On/Standby button.
IEC 60417-5140 - Equipment includes RF Transmitter.
Wireless connectivity.
Do not re-sterilize.
Sterilized with ethylene oxide.
Mass.