AGENCY & REGULATORY APPROVALS
Overview
FCC/CE Class B for IT and medical applica-
tions
UL recognized component for near patient
use in US & Canada, ETL control number
4007055. Conforms to UL 60601-1, Certi-
fied to CSA STD C22.2 NO.601.1
RoHS Compliant (lead-free)
FEDERAL COMMUNICATIONS COMMISSION
RADIO FREQUENCY INTERFERENCE STATEMENT
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. These
limits are designed to provide reasonable pro-
tection against harmful interference when the
equipment is operated in a residential installa-
tion.
This equipment generates, uses and can radiate
radio frequency energy and, if not installed and
used in accordance with the instructions, may
cause harmful interference to radio communica-
tions. However, there is no guarantee that inter-
ference will not occur in a particular installation.
If this equipment does cause harmful interfer-
ence to radio or television reception, which can
be determined by turning the equipment off and
on, the user is encouraged to try to correct the
interference by one or more of the following
measures:
Reorient or relocate the receiving antenna
Increase the separation between the
equipment and receiver
Connect the equipment into an outlet on a
circuit different from that to which the
receiver is connected
Consult the dealer or an experienced ra-
dio/TV technician for help
Warning
To assure continued FCC compliance, the user
must use only shielded interfacing cables when
connecting to computer or peripheral. Also, any
unauthorized changes or modifications to this
equipment would void the user’s authority to
operate.
INDUSTRY CANADA COMPLIANCE STATEMENT
This Class B digital apparatus meets all
requirements of the Canadian Interface-
causing Equipment Regulations. Cet Ap-
pareil numérique de la classe B respecte
toutes les exigences du Règlement sur le
matérial broilleur du Canada.
CE COMPLIANCE FOR EMISSIONS AND IMMUNI-
TY
This device has been tested to comply with the
following European standards for emissions and
immunity for ITE and medical equipment:
En 55022, En 55024, EN 61000-3-2/3, and
EN 60601-1-2.
MEDICAL PRODUCT SAFETY
Savant Elite2 products are recognized compo-
nents, conforming to UL standard 60601-1; Certi-
fied to CSA standard C22.2 NO. 601.1. The ETL
listing number is 4007055.
The ETL Recognized Component mark on the
product label indicates compliance with UL
60601-1 and CSA Std C22.2 No. 601.1 standards
for medical use. These products must be used
with a UL-listed computer or UL-listed computer-
ized equipment to comply with UL safety stand-
ards. The label will also indicate either IPX1 per
UL and CE standards for “drip-proof” water
resistance, or IPX8 for waterproof models.
This USB input device was not designed as a fault
-tolerant medical device. In a medical setting, it
is intended for use as a component of a UL-listed
diagnostic instrument, not for patient care.
This product should not be used in the presence
of a flammable atmosphere such as an anes-
thetic mixture with air, oxygen, or nitrous oxide.
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