nalu 12001-040 User Instructions For Use page 4

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