Nalu
User’s Kit Instructions for Use PN: MA-000007 Rev J
Page
4
of
80
MR Conditional
Medical device demonstrated
safety in the MR environment
within defined conditions.
ASTM F2503-13
Fig. 6
MR Unsafe
Medical device poses
unacceptable risks to the
patient, medical staff or other
persons within the MR
environment.
ASTM F2503-13
Fig. 9
Radio Transmitter
Device contains a radio-
frequency (RF) transmitter,
which may cause RF
interference with other devices
near this device
IEC 60601-1-
2:2007
5.1.1
Prescription use only
Caution: Law prohibits
dispensing without prescription
21 CFR 801.109
N/A
Quantity
Indicates the total number of
products provided in a package.
N/A
N/A
Serial Number
Manufacturer’s serial number so
that a specific medical device
can be identified.
ISO 15223-1
5.1.7
Best Before
This device is best used before
this date.
N/A
N/A
Authorized
Representative in the
European
Community
Authorized representative in the
European Community
ISO 15223-1
5.1.2
Protected against
electric shock
Device contains a type BF
applied part to protect you from
shock. The device is internally
powered and is intended for
continuous operation
IEC 60417
5333