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Pro-Select Platinum®
Operation and Instruction Manual
Disclaimers and Special Conditions
• Equipment is not suitable for use in presence of a flammable anesthetic mixture with air OR with oxygen OR with
nitrous oxide.
• Equipment is not intended to be defibrillation proof.
• Some accessories must be sterilized according to common clinical practice. Other accessories may be sterilized
according to choice. No accessories are supplied in a sterile condition.
• Equipment is designed for intermittent operation. When using equipment, there is a potential for
electromagnetic interference with other devices. If there is interference, operate only one of the pieces
of equipment at a time or physically move them apart until the interference is no longer a problem.
• There are no waste products or residues that will be generated during the operation of equipment.
• There are user changeable accessories, but no user serviceable parts in Pro-Select Platinum equipment.
• There are no special humidity or temperature environmental conditions for transport or storage.
• Please dispose of any and all component parts of this product according to all local and national
regulations governing the disposal of electronic devices.
• Service is to be performed by a qualified DenMat professional only.
• Pacemakers and Ultrasonics - Modern pacemakers are shielded against electromagnetic interference. However,
most electronic devices do generate an electromagnetic field. Refer to the patient’s cardiologist for approval to
treat with ultrasonic instrumentation.
Guidance and manufacturer's declaration - electromagnetic emissions
PSP® is intended for use in the electromagnetic environment specified below. The customer or the user of Pro-Select Platinum should assure that it is used in
such an environment.
Emissions Test Compliance
Electromagnetic environment - guidance
“RF emissions CISPR 11”
Group 1
PSP® uses RF energy only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equip-
ment.
“RF emissions CISPR 11”
Class A
PSP® is suitable for use in all establishments other than domestic and those
directly connected to the public low voltage power supply network that supplies
buildings used for domestic purposes.
“Harmonic emissions IEC 61000-3-2”
Not applicable
“Voltage fluctuations/
flicker emissions Complies IEC 61000-3-3”
Complies
Guidance and manufacturer’s declaration electromagnetic emissions
PSP® is intended for use in the electromagnetic environment specified below. The customer or the user of Pro-Select Platinum® should assure that it is used
in such an environment.
Emissions Test
IEC 60601 test level
Compliance
Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC61000-4-2
±6kVcontact ±8kVair
A
Floors should be wood, concrete, or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be
at least 30%.
Electrical fast transient/burst IEC61000-4-4
±2kVforpowersupply lines
±1kVforinput/output lines
A
Mains power quality should be that of a typical commercial or
hospital environment.
Surge IEC61000-4-5
±1kVdifferentialmode
±2kVcommonmode
A
Mains power quality should be that of a typical commercial or
hospital environment.
Voltage dips, short interruptions and voltage
variations on power supply input lines IEC61000-
4-11
<5%UT(>95%dipinUt)
for 0.5 cycle
<40%UT(60%dipinUt )
for 5 cycle
<70%UT(70%dipinUt )
for 5 cycle
<70%UT(70%dipinUt )
for 5 cycle
A, C
Mains power quality should be that of a typical commercial or
hospital environment. If the user of Pro-Select Platinum requires
continued operation during power mains interruptions, it is
recommended that Pro-Select Platinum be powered from an
uninterruptible power supply or a battery.
Power frequency (50/60Hz)magnetic field
IEC61000-4-8
3A/m
A, C
Power frequency magnetic fields should beat levels characteristic
of a typical location in a typical commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level. Compliance level A: Provides essential performance and remains safe. Compliance level
C: Loss of essential performance provided the Equipment Under Test remains safe, experiences no component failure and is restorable to the pre-set state
with operator intervention.