Electromagnetic Compatibility Declaration - Cala Health Cala Trio CT1-STR Health Care Professional Manual

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ELECTROMAGNETIC COMPATIBILIT Y
DECL ARATION
Cala Trio Stimulator claims compliance for
electromagnetic compatibility in conjunction with Cala
Trio Base Station.
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired operation.
Do not tamper with, modify, or attempt to perform
maintenance or servicing on Cala Trio.
RF Exposure Evaluation Guidance for Mobile Conditions
A minimum separation distance of 20 cm is required
between the Cala Trio Base Station and nearby person to
qualify for mobile exposure limits.
GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS
Cala Trio is intended for use in the electromagnetic environment specified below. The customer or the user of Cala Trio should assure that it is
used in such an environment.
EMISSIONS TESTS COMPLIANCE
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage Fluctuations/
Complies
Flicker emissions
GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNIT Y
Cala Trio is intended for use in the electromagnetic environment specified below. The customer or the user of Cala Trio should assure that it is
used in such an environment.
IMMUNITY TEST IEC 60601 TEST LEVEL
Electrostatic
±8 kV contact
discharge (ESD)
±15 kV air
IEC 61000-4-2
Electrical fast
±2 kV for power supply lines
transient/burst
±1 kV for input/output lines
IEC 61000-4-4
Surge ±1 kV differential mode
IEC 61000-4-5 ±2 kV common mode
(50/60 Hz)
magnetic field 30 A/m
IEC 61000-4-8
LBL-5122 Rev C NOV 2019
Cala Trio 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.
Cala Trio is suitable for use in all establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network that supplies buildings used for
domestic purposes.
COMPLIANCE LEVEL
±8 kV contact
±15 kV air
±2 kV for power supply
lines
±1 kV differential mode
±2 kV common mode
30 A/m
Questions about Cala Trio? Visit CalaTrio.com/HCPFAQs
GENERAL RADIO COMPLIANCE
ITEM SPECIFICATION
Stimulator
FCC ID: 2AA9B05
Bluetooth
Radio Frequency
2402 MHz to 2480 MHz
(RF) Range
Base Station FCC ID: 2AT2D-BASE0017
Radio Frequency 13.56 MHz
(RF) Range 2402 MHz to 2480 MHz
LTE Module FCC ID: XPY2AGQN4NNN
Device operates within approved frequencies
overlapping with the following cellular bands:
Radio Frequency
LTE 2,1900 PCS UP | LTE 25,1900+ UP | LTE
(RF) Range
35,TD PCS Lower DOWN | UMTS CH 2 UP |
UMTS CH 25 UP | UMTS CH 35 DOWN |
ELECTROMAGNETIC ENVIRONMENT GUIDANCE
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%.
Mains power quality should be that of a typical commercial
or hospital environment.
Mains power quality should be that of a typical commercial
or hospital environment.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
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