Owner's Guide
XIV. EMC Information, Warnings and Considerations:
1. This equipment generates, uses, and can radiate radio frequency energy, and if not installed and used in accordance with the instruction
manual, may cause interference to radio communications. Operation of this equipment in a manner inconsistent with this manual is likely
to cause interference in which case the user, at his own expense, will be required to take whatever measures may be required to correct
the interference.
2. Persons fitted with cardiac pacemakers have been cautioned that some types of electronic equipment might interfere with
the operation of a pacemaker. Although no instance of pacemaker interference relating to a BioSonic Ultrasonic Scaler has
ever been reported to Coltène/Whaledent Inc., we recommend that the handpiece and cables be kept at least 6 to 9 inches
(15 to 23 cm) away from any pacemaker and pacemaker leads during use. If use of this product is in question, consult
patient's cardiologist.
3. Use of US100R cables and accessories, other than those provided by Coltène/Whaledent, may result in increased emissions or decreased
immunity.
4. Listed cables:
a. Handle & Cord Assembly – Coltene Part # 28223
b. Footswitch & Cord Assembly – Coltene Part # 28225
5. Electromagnetic Compatibility:
The following are guidance and manufacturer's declarations regarding electromagnetic compatibility for the BioSonic® US100R.
5.1
E N/IEC
6 0601-‐1-‐2
T able
1
The
B ioSonic®
U S100R
i s
i ntended
f or
u se
i n
t he
e lectromagnetic
e nvironment
s pecified
b elow.
T he
customer
o r
t he
e nd
u ser
o f
t he
B ioSonic®
U S100R
s hould
a ssure
t hat
i t
i s
u sed
i n
s uch
a n
environment.
Emissions
t est
RF
e missions
C ISPR
1 1:2004
RF
e missions
C ISPR
1 1:2004
Harmonic
e missions
I EC
6 1000-‐3-‐2
Voltage
f luctuations/Flicker
e missions
I EC
61000-‐3-‐3
Guidance
a nd
M anufacturer's
D eclaration
–
E lectromagnetic
E missions
Compliance
Electromagnetic
e nvironment
-‐
guidance
Group
1
The
B ioSonic®
U S100R
u ses
R F
energy
o nly
f or
i ts
i nternal
function.
T herefore,
i ts
R F
emissions
a re
v ery
l ow
a nd
a re
not
l ikely
t o
c ause
a ny
interference
i n
n earby
electronic
e quipment.
Class
B
The
B ioSonic®
U S100R
u nit
i s
suitable
f or
u se
i n
a ll
Class
A
establishments
o ther
t han
Complies
domestic,
a nd
m ay
b e
u sed
i n
domestic
e stablishments
a nd
those
d irectly
c onnected
t o
t he
public
l ow-‐voltage
p ower
s upply
network
t hat
s upplies
b uildings
for
d omestic
p urposes,
p rovided
the
f ollowing
w arning
i s
heeded:
Warning:
T his
e quipment
i s
intended
f or
u se
b y
h ealthcare
professionals
o nly.
T his
equipment
m ay
c ause
r adio
interference
o r
m ay
d isrupt
t he
operation
o f
n earby
e quipment.
It
m ay
b e
n ecessary
t o
t ake
mitigation
m easures
s uch
a s
r e-‐
orienting
o r
r elocating
t he
BioSonic®
U S100R
u nit
o r
shielding
t he
l ocation.
7