Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C
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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
Protected against access to
certain hazardous parts
Protected against solid objects over
12.5mm (e.g., a finger) and protected
against falling drops of water, if the
case is disposed at any angle up to
15 degrees from vertical
IEC 60529
N/A
Protected from dust and
temporary immersion in
water
Protected from dust and against
effects of immersion in water up to
1m depth for 30 mins
IEC 60529
N/A
FCC
This symbol indicates that this
equipment has been tested and
found to comply with the limits for a
Class B digital device, pursuant to
part 15 of the FCC Rules.
47 CFR 2.926
N/A
Do not throw in the trash
This product shall not be treated as
household waste. Instead it is the
user’s responsibility to return this
product to Nalu Medical for
reprocessing.
By ensuring that this product is
disposed of properly, you will help
prevent potential negative
consequences for the environment
and human health, which could be
caused by inappropriate waste
handling of this product. The
recycling of materials will help to
conserve natural resources.
For more information about how to
return this product for recycling,
please contact Nalu Medical.
BS EN 50419 Marking of
Electrical and Electronic
Equipment in Accordance
with Article 11(2) of
Directive 2002/96/EC
(WEEE)
Fig. 1
IP22
