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5. Electro-Magnetic Compatibility Information
▪
There is an LED that emits UV-C wavelengths inside the i700 wireless handpiece. It is irradiated only inside the i700 wireless handpiece and does
not go outside. The blue light visible inside the i700 wireless handpiece is for guidance, not UV-C light. It is harmless to the human body.
▪
The UV-C LED operates with a wavelength of 270 - 285 nm.
▪
Disclaimer for Risks Involving Patients with Epilepsy
The Medit i700 wireless should not be used on patients that have been diagnosed with epilepsy due to the risk of seizures and injury. For the
same reason, dental staff who have been diagnosed with epilepsy should not operate the Medit i700 wireless.
4.7
Explosion Hazards
WARNING
▪
The i700 wireless system is not designed to be used near flammable liquids, gases, or in environments with high oxygen concentrations.
▪
There is a risk of explosion if you use the i700 wireless system near flammable anesthetics.
▪
The rechargeable battery used with the i700 wireless is designed with safety devices included.
▪
The rechargeable battery shall not be exposed to excessive heat such as sunshine or the like. Failure to observe this could result in the battery
explosion. Please be careful with the storage and maintenance of the battery.
▪
The battery charger is designed to adjust the current supply after charging is complete. But if it is not going to be used for a long time, disconnect
the power to the battery charger or remove the fully charged battery from the battery charger.
4.8
Pacemaker and ICD Interference Risk
WARNING
▪
Do not use the i700 wireless system on patients with pacemakers and ICD devices.
▪
Check each manufacturer's instructions for interference by peripheral devices, such as computers used with the i700 wireless system.
5.1
Electromagnetic Emissions
The i700 wireless system is intended for use in the electromagnetic environment as specified below. The customer or the user of the i700 wireless system
should ensure that it is used in such an environment.
Emission Test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonic Emissions IEC 61000-3-2
Voltage Fluctuations / Flicker
Emissions
WARNING
This i700 wireless system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation
of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the i700 wireless or shielding the location.
5.2
Electromagnetic Immunity
▪
G uidance 1
T he i700 wireless system is intended for use in the electromagnetic environment as specified below. The customer or the user of the i700
wireless system should ensure that it is used in such an environment.
Immunity Test
± 8 kV contact ± 2 kV,
Electrostatic Discharge
± 4 kV, ± 8 kV, ± 15 kV
(ESD) IEC 61000-4-2
air
±2 kV for power
Electrical Fast
supply lines
Transient / Burst IEC
±1 kV for input/output
61000-4-4
lines
±0.5 kV, ±1 kV
differential mode
Surge IEC 61000-4-5
±0.5 kV, ±1 kV, ±2 kV
common mode
Voltage Dips, Short
0% Uт (100% dip in Uт)
Interruptions, and
for 0.5/1 cycles
Voltage Variations on
70% Uт (30% dip in Uт)
Power Supply Input
for 25/30 cycles
Lines
0% Uт (100% dip in
IEC61000-4-11
Uт) for 250/300 cycles
14
User Manual
Guidance and Manufacturer's Declaration – Electromagnetic Emission
Compliance
Group 1
Class A
Class A
Complies
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
IEC 60601 Test Level
± 8 kV contact ± 2 kV,
± 4 kV, ± 8 kV, ± 15 kV
air
±2 kV for power
supply lines
±1 kV for input/output
lines
±0.5 kV, ±1 kV
differential mode
±0.5 kV, ±1 kV, ±2 kV
common mode
0% Uт (100% dip in Uт)
for 0.5/1 cycles
70% Uт (30% dip in Uт)
for 25/30 cycles
0% Uт (100% dip in
Uт) for 250/300 cycles
Electromagnetic Environment – Guidance
The i700 wireless 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
equipment.
The i700 wireless is suitable for use in all establishments.
This includes domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Compliance Level
Electromagnetic Environment ‐ Guidance
Floors should be made of wood,
concrete, or ceramic tiles. If floors are
covered with a synthetic material,
relative humidity of at least 30% is
recommended.
The mains power quality should be
that of a typical commercial or hospital
environment.
The mains power quality should be
that of a typical commercial or hospital
environment.
The mains power quality should be
that of a typical commercial or hospital
environment. If the user of the i700
Wireless system requires continued
operation during power mains
interruptions, it is recommended that
the i700 wireless system be powered
from an uninterruptible power supply
or a battery.
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