Universal XactTrace
®
User Instructions
4
Symbol
Standard
Reference
Standard Title of
Symbol
Symbol Title
as per
Referenced
Standard
Explanation
N/A
NA
N/A
Hand wash only
N/A
NA
N/A
Do not tumble dry
Directive
2012/19/EU
Waste Electrical and
Electronic
Equipment (WEEE)
Disposal at
end of
operating
life
instructions
Indicates that
electrical and
electronic equipment
waste should not be
discarded together
with unseparated
waste but must be
collected separately.
21 CFR
801.109(b)(1)
Labeling-
Prescription devices
Device is
cleared for
the US
market as
requiring a
prescription
Indicates that the
product is authorized
for sale by or on the
order of a licensed
healthcare
practitioner.
ISO 15223-1
Symbol 5.1.8
Symbols to be used
with information to
be supplied by the
manufacturer
— Part
1: General
requirements
Importer
Indicates the entity
importing the medical
device into the locale.
ISO 15223-1
Symbol 5.1.9
Symbols to be used
with information to
be supplied by the
manufacturer
— Part
1: General
requirements
Distributor
Indicates the entity
distributing the
medical device into
the locale.
Warnings and Cautions
•
XactTrace shall be worn over the patient's clothing.
•
Do not stretch the belts too tightly around the patient as this may cause
discomfort. To prevent the belt from slipping during the night, fix the position
of the belt with medical tape.
•
Caution must be taken to ensure that cables do not encircle the patient's
neck. Special attention is needed in the case of children.
•
Use the device only under the direction and supervision of a physician or
trained technologist.
•
Avoid all unnecessary contact with moisture when using the device.
•
Do not use damaged belts or cables.
•
Caution: U.S. Federal law restricts this device to sale by, or on the order of,
a physician.
