Serious Injury Reporting; Warranty And Disclaimer Information; Electromagnetic Compatibility - Nice NICE1 User Manual

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SERIOUS INJURY REPORTING

If a serious incident has occurred, please report to Nice Recovery Systems, LLC using
the contact information noted in Technical Support section of this User Manual. If in the
European Union, please also report to your Competent Authority where the serious
incident has occurred.
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WARRANTY AND DISCLAIMER INFORMATION

Limited Warranty Terms: Nice Recovery Systems LLC ("Nice Recovery") warrants to the
immediate purchaser from Nice Recovery or an immediate purchaser of an unused unit
from an authorized distributor of Nice Recovery products, that any Nice Recovery
Systems will be free from defects in workmanship and material under normal use for
one year (1) after the date of purchase. Nice Recovery warrants to the immediate
purchaser from Nice Recovery, or an immediate purchaser of an unused wrap from an
authorized distributor of Nice Recovery products, that Nice Recovery single patient use
wraps will be free from defects in workmanship and material under normal use for only
the first use of the wrap.
This Limited Warranty covers only defects in material or workmanship. Therefore, it
does not cover any other claim, service, defect, condition, or damage, including:
installation, set-up, instructions, recommendations on use; accidents, tampering,
improper product selection, misuse, neglect, or abnormal use; use of parts,
accessories or fluids that are incompatible or adversely affect operation, performance,
or durability; unauthorized service, repair or alteration; excessive moisture or
humidity; cleaning or any condition caused by any dirt or foreign substance on or in the
product; or damages resulting from shipping. Installation or use of the product or any
portion thereof in a manner that does not comply with the Operating Instructions voids
the warranty. Any alteration or modification that changes the product's effectiveness
or intended use voids the warranty.
Nice Recovery will, at its discretion, repair or replace within a reasonable time any
product that is found to have a defect in material or
workmanship under normal use during the applicable warranty period. This is the
immediate purchaser's sole remedy. Any warranty on a repair or replacement expires
the same time as the warranty expires or would have expired on the original product.
The product must be returned at the immediate purchaser's expense to an authorized
Nice Recovery Service Center for warranty service.
Because Nice Recovery Systems updates and advances its products and technology,
Nice Recovery Systems reserves the right to modify or improve the design of any
product without assuming any obligation to modify any product previously
manufactured.
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3-100176, REV E

ELECTROMAGNETIC COMPATIBILITY

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GUIDANCE AND MANUFACTURER'S DECLARATION:
ELECTROMAGNETIC IMMUNITY AND EMISSIONS
The NICE1 is intended for use in the electromagnetic environment specified below. The customer or the user of
the NICE1 should assure that it is used in such an environment.
EMC TEST IEC 60601-1-2 LEVEL
RF CISPR 11:2009+A1:2010
emissions Class B, Group 1;
CISPR 11 IEC 60601-1-
2:Ed.4.1 (4th
Edition)
CISPR 11:2009+A1:2010
AC Power Line
Conduct- ed Class B, Group 1
Emissions, 150 kHz –
30 MHz
AC Harmonic IEC 61000-3-2:2005
current emissions +A1:2008+A2:2009
Voltage changes, IEC 61000-3-3:2013
fluctuations, and
flicker
ElectrostaticDischarge IEC 61000-4-2:2008
immunity ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV
air
Radiated RF Immunity IEC 61000-4-3:2006
+A1:2007+A2:2010
10 V/m 80 MHz – 2.7 GHz
80 % AM at 1 kHz
Electrical Fast Transients IEC 61000-4-4:2012
/ Bursts ± 2 kV
Applied to AC 100 kHz repetition frequency
input no I/O 3 M
or longer
Surge immunity IEC 61000-4-5:2005
test Applied to Line to Line:
AC input ± 0,5 kV, ± 1 kV
Line to Gnd:
± 0,5 kV, ± 1 kV, ± 2 kV
3-100176, REV E
TESTED
ELECTROMAGNETIC
COMPLIANCE ENVIRONMENT GUIDANCE
LEVEL
CISPR 11:2009+A1:2010 The NICE1 uses RF
Class B, Group 1; energy only for its internal function.
IEC 60601-1- Therefore, its RF emissions are very
2:Ed. 4.1 low and are not likely to cause any
b:2014 (4th Edition) interference in nearby electronic
equipment.
CISPR 11:2009+A1:2010
The NICE1 is suitable for use in all
Class B, Group 1 establishments, including domestic
establishments and those directly
connected to the public mains that
supplies buildings used for domestic
purposes.
IEC 61000-3-2:2005 The NICE1 power supply electrical
+A1:2008+A2:2009 harmonics are very low and is suitable
for use in all establishments, including
domestic establishments and those
directly connected to the public mains
that supplies buildings used for domestic
purposes.
IEC 61000-3-3:2013 Mains power quality can be that of a
typical hospital, commercial, or home
environment.
IEC 61000-4-2:2008 While this testing level is high it is not
± 8 kV contact the maxi- mum observed in some
± 2 kV, ± 4 kV, ± 8 kV, ± 15 areas with very low humidity. If used in
kV air
a known very dry location the user
should try to discharge/ground
themselves before using the unit.
IEC 61000-4-3:2006 While tested to a high level, interference
+A1:2007+A2:2010 may occur in the vicinity of equipment
10 V/m 80 MHz – 2.7 GHz marked with the following symbol:
80 % AM at 1 kHz
IEC 61000-4-4:2012 Mains power quality can be that of a
± 2 kV typical hospital, commercial, or home
100 kHz environment.
repetition
frequency
IEC 61000-4-5:2005 Mains power quality can be that of a
Line to Line: typical hospital, commercial, or home
± 0,5 kV, ± 1 kV environment.
Line to Gnd:
± 0,5 kV, ± 1 kV, ± 2 kV
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