Electromagnetic Compatibility (Emc) Information; Specifications - Tivic Health ClearUP User Manual

Electromagnetic Compatibility
(EMC) Information
IEC 60601-1-2 Clause 5
5.1 Specified Type of Shielded
Location
5.2 Accompanying Documents
5.2.1 Instruction for Use
5.2.1.1 General
5.2.1.1 (a) Statement of
Environments
5.2.1.1 (b) Essential
Performance
5.2.1.1 (c) Warning Statement:
Used equipment adjacent to or
stacked with other equipment
5.2.1.1 (d) List of all cables and
other accessories
5.2.1.1 (e) Warning Statement
of using other accessories and
cables.
5.2.1.1 (f) Warning Statement
of using portable RF
communication equipment
5.2.1.2 Classified Class B
according to CISPR 11
5.2.2 Technical Description
5.2.2.1 (a) Compliance to
Emissions and Immunity
20
Location in Instruction
for Use (User Guide)
N/A
Included
Page 19 (Specifications
table)
ClearUP Sinus Pain Relief
will deliver microcurrent of
a specific value.
Page 11
Page 12
Page 11
N/A
Device meets CISPR 11
Class B limits
Page 12-13
Page 20-24
Electromagnetic Compatibility
(EMC) Information
IEC 60601-1-2 Clause 5
5.2.2.1 (b) Deviation from
collateral standard and
allowances used
5.2.2.1 (c) All Necessary
Instruction for maintaining Basic
Safety and Essential Performance
5.2.2.2 (a) Warning Failure to use
equipment in the specified type of
shielded location
5.2.2.2 (b) Specifications for the
shielding location
5.2.2.2 (c) Recommended test
methods for measurement of RF
shielding
5.2.2.2 (d) Recommendation
of equipment allowed inside
shielded location
5.2.2.3 ME equipment
intentionally receives RF
electromagnetic energy for the
purpose of its operation
5.2.2.4 ME equipment that
includes RF transmitters
5.2.2.5 (a) Statement that
exempted from RF immunity
at frequency range
5.2.2.5 (b) Warning: Use nearby
of emitters at other frequencies
could result in improper operation
5.2.2.5 (c) List of the frequencies
and modulations used to test
Immunity
5.2.2.6 ME Equipment that claim
compatibility with HF Surgical
equipment
Location in Instruction
for Use (User Guide)
N/A
Page 8 -11
N/A
N/A
N/A
N/A
N/A
N/A
150KHz-80MHz, 1Khz, Sine, @ 80%
AM (Amplitude Modulation)
80Mhz – 2,700MHz, 1Khz, Sine,
@ 80% AM
C1) 380 - 390MHz – 18Hz PM (Pulse
Modulation)
C2) 430 - 470MHz – 1K Sine, @ 80% AM
C3) 710, 745 & 780MHz – 217Hz PM
C4) 810, 870 & 930MHz – 18Hz PM
C5) 1720, 1845 & 1970MHz- 217Hz PM
C6) 2450 – 2570MHz – 217Hz PM
C7) 5240, 5500 & 5785Mhz – 217Hz PM
N/A
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