Tivic Health ClearUP User manual

User’s
Guide

Questions?
tivichealth.com
1-888-276-6888
customerservic[email protected]
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1 year warranty
Triple action
drug-free
relief from
allergy sinus pain, sinus
headaches, and congestion.

Introduction
Device Description
How It Works
Clinical Study Results
Safety Information
Symbols and Definitions
Getting Started
Unpacking
Charging
User Controls and Indicators
Basic Operation Instructions
Frequently Asked Questions
Maintenance
Troubleshooting
Specifications
Electromagnetic Compatibility
(EMC) Information
Warranty and Customer Service
4
7
8
9
13
15
16
16
16
16
18
20
21
22
23
24
29
Table of Contents
Triple action
drug-free
relief from
allergy sinus pain, sinus
headaches, and congestion.

4
Introduction
Sinus pain and congestion can make you
miserable. Traditional medication, sprays, and
flushes may have side eects and may not
provide eective sinus pain and congestion relief.
ClearUP® is dierent. It’s at the forefront of
technology and works even when nothing else
does. ClearUP applies gentle pulses to reduce
symptoms of inflammation such as sinus pain and
congestion. Safe and subtle microcurrents are
emitted from the tip of the unit to the sinus nerve
fibers below the skin. ClearUP works with your
body’s natural electricity to directly target pain at
the source without drugs or chemical side eects.
ClearUP is:
FDA approved
Clinically safe and eective as
demonstrated through clinical trials
100% drug-free
Compact, convenient,
and perfect for on-the-go
treatments
4

Intended Use
ClearUP Sinus Pain Relief is to be used for
the temporary relief of sinus pain associated
with allergic rhinitis and moderate to severe
congestion. ClearUP is for adults 18+ years
old only.
What causes sinus pain conditions?
Sinus pain can be caused by allergic rhinitis. Sinus
pain is also associated with migraines, dental
infections or muscle tension, which may require
medical attention.
What is allergic rhinitis?
Allergic rhinitis is caused by exposure to airborne
allergens. It is often called hay-fever. There are
two types of allergic rhinitis, seasonal and year-
round. Seasonal allergic rhinitis can be triggered
by various pollens and mold while year-round
allergies can be triggered by pet dander, mold,
dust, cleaning products, and perfumes.
Symptoms include sneezing, congestion, runny
nose, watery eyes, itching of the nose or roof of
the mouth, coughing, and sinus pain.

What causes congestion?
How bad is your congestion?
How much of a problem are the
following conditions for you?
Congestion can be caused by anything that
irritates or inflames the nasal tissues which
could be caused by the common cold, the flu,
sinusitis, and respiratory allergies.
Before first use, make a note of your
congestion symptoms severity using the scale
below. If you are at levels 3, 4, or 5 (moderate
to severe), ClearUP can help. After two weeks,
evaluate your level of congestion relief. If
you have not experienced at least 1 point of
reduction in congestion, this device may not
be eective for your congestion symptoms.
This device is not eective for 100% of users.
Not a
Problem
Very Mild
Problem
Mild
Problem
Moderate
Problem
Fairly Bad
Problem
Try
Severe
Problem
Congestion and stuness
01 2 3 4 5

7
ClearUP Sinus Pain Relief (ClearUP) is a
handheld microcurrent stimulation reusable
device intended to be used at home for the
temporary relief of sinus pain and moderate to
severe congestion. The unit applies very low
levels of microcurrent to the skin overlying the
paranasal sinuses, and continuously measures
skin impedance as the user glides the electrode
along the skin. When the skin impedance
measurement drops below a threshold, ClearUP
identifies this as a treatment point in the facial
skin which allows current to pass most easily
across the skin. The device emits a brief haptic
feedback through vibration (haptic vibration)
at each treatment point. These low-impedance
points correlate with subcutaneous nerve fibers
and foramina (holes) through which major nerve
fibers pass from the sinus passages, through the
skull, to areas near the skin.
The device is held in the hand, with the rounded
tip of the device applied to the facial skin in the
region of the sinus passages.
Once the haptic vibration ends at a treatment
point, the user is instructed to glide the device
along the visually indicated path until reaching
the next treatment point at which the haptic
vibration will commence again.
Device
Description

8
ClearUP works in several ways
• Safe microcurrent is emitted from the tip of the
unit to sinus nerve fibers under the skin.
• Electrical stimulation of nerves reduces feelings
of sinus pain for up to 6 hours according to our
clinical study.
• Published research has shown that electrical
stimulation can also shrink swollen tissue;
swelling is often a key cause of nasal and
sinus symptoms.1-4
How It Works
Nerve
Pathways
1. Goldsobel, Alan B., Niveditha Prabhakar, and Blake T. Gurfein.
“Prospective trial examining safety and efcacy of microcurrent
stimulation for the treatment of sinus pain and congestion.”
Bioelectronic Medicine 5.1 (2019): 1-9.
2. Mandel, Yossi, et al. “Vasoconstriction by electrical stimulation:
new approach to control of non-compressible hemorrhage.”
Scientic reports 3 (2013).
3. Franco, O. S., et al. “Effects of different frequencies of
transcutaneous electrical nerve stimulation on venous vascular
reactivity.” Brazilian Journal of Medical and Biological Research
47.5 (2014): 411-418.
4. Malm, L. “Stimulation of sympathetic nerve bres to the nose in
cats.” Acta oto-laryngologica 75.2-6 (1973): 519-526.
Note: ClearUP must be self-administered and cannot be applied to
another person. This is due to the electrical circuit design. The hand
holding the device completes the electrical path

9
Study 1
At the end of the study, subjects were asked
to compare their level of congestion before
treatment and ten minutes after treatment
by completing the modified nasal obstruction
symptom evaluation (NOSE) questionnaire. 59
study subjects reported moderate to severe
Clinical Study Results
3 out of 4 felt relief preferred ClearUP
The Sinus Center at Stanford University
conducted a double-blind, randomized controlled
clinical study using the ClearUP Sinus Pain Relief
device. A total of 71 subjects suering from sinus
pain (27 subjects with chronic rhinosinusitis, 49
subjects suering from allergic rhinitis, and 5
subjects with other sinus conditions) enrolled in
the study. 38 subjects were randomly selected to
use the ClearUP Sinus Pain Relief “active” device
and 33 subjects were randomly selected to use
the “sham” device (a device with haptic vibration
but no microcurrent stimulation). Each subject
used the active or sham device on the outside of
their sinus passages without any assistance for a
single five-minute treatment. Each subject rated
their level of pain before and ten minutes after
treatment.
Note: 24% who used the microcurrent device experienced sinus
pain reduction of 3 points or more on the visual analog pain scale
(0 no pain to 10 severe pain). Only one subject experienced minor
reddening of the skin which disappeared within minutes.
82% 74%

10
levels of congestion before treatment. For these
subjects, post hoc analysis results were:
• 70% of users (21 subjects out of 30 subjects
treated with the active device) experienced
a clinically important reduction in congestion
symptoms within 10 minutes of treatment.
• The average magnitude of congestion symptom
reduction was 35%. For example, subjects were
better able to breathe through their noses and
reported less nasal stuness and blockage.
• 82% (31 subjects out of 38 subjects treated
with the active device) preferred ClearUP Sinus
Pain Relief device to their current sinus pain
treatment method(s). 91% (29 subjects out
of 32 subjects treated with the sham device)
preferred the sham device to their current
sinus pain treatment method(s), which may
be attributable to the therapeutic eect of the
haptic feedback emitted by the sham device,
preference for non-drug treatment options, or
placebo response.
Although other published studies have
concluded that subjects can accurately recall
symptom severity from previous days, the
above Clinical trial involved collecting data on
symptom severity from 10 minutes prior. In
conclusion, the subgroup of ClearUP-treated
subjects with moderate to severe congestion
reported significantly greater congestion
symptom relief and eectiveness can be noticed
within 10 minutes of treatment cycle.

11
88%
reduction in sinus pain
after 4 weeks
reduction in congestion
after 4 weeks
of subjects felt
congestion relief
Up to 6 hours
of pain relief
Study 2
A single arm (N=30) open-label clinical study
using the ClearUP Sinus Pain Relief device
was conducted at the Allergy and Asthma
Associates of Santa Clara Valley Research
Center. Included were 11 subjects with allergic
rhinitis, 1 subject with a nasal cyst, 1 subject with
nasal polyps, and 17 subjects with undiagnosed
causes of sinus symptoms. Subjects used the
ClearUP device for five minutes during the
study visit and then took the device home with
them with instructions to use the device once
daily and up to four times daily as needed for 4
weeks, with each treatment lasting five minutes.
Subjects rated their level of congestion before
treatment and weekly for four weeks during
treatment using the congestion quantifier seven
(CQ7) instrument. 24 subjects enrolled with
moderate to severe levels of congestion. For
these patients, the results of the clinical trial
were as follows:
• The average magnitude of congestion
symptom reduction was 44% after four weeks
44%
43%6
hours
(Post-Market Clinical Study)

12
Two key clinical studies and FDA approval
demonstrated that ClearUP is a safe and eective
treatment for sinus pain associated with allergic
rhinitis and moderate to severe congestion.
1. Schenkel, E. J., Ciesla, R., & Shanga, G. M. (2018). Effects of nasal
dilator strips on subjective measures of sleep in subjects with
chronic nocturnal nasal congestion: a randomized, placebo-
controlled trial. Allergy, Asthma & Clinical Immunology, 14(1), 34
2. Katotomichelakis, M., Van Crombruggen, K., Holtappels, G., Kuhn,
F. A., Fichandler, C. E., Kuhn-Glendye, C. A., ... & Kastanioudakis,
I. (2017). A herbal composition of Scutellaria baicalensis and
Eleutherococcus senticosus shows vasocontrictive effects in
an ex-vivo mucosal tissue model and in allergic rhinitis patients.
Clinical Phytoscience, 3(1), 21.
of use. For example, subjects experienced
nasal stuness, blockage, and congestion
less frequently and were better able to
breathe through their noses.
• 73% preferred ClearUP Sinus Pain
Relief device to their current sinus pain
treatment(s).
Note: Only two subjects experienced minor reddening of the skin
and one subject experienced an eyelid muscle twitch, both of
which resolved without treatment.
Study 2 was an open-label 4-week study and
did not have a control group or a placebo.
To address the uncertainty created by this
design, we conducted a literature review to
identify the magnitude of the placebo eect in
subjects with congestion that completed the
Congestion Quantifier 7 (CQ7) questionnaires.
The literature search identified two peer-
reviewed papers.1,2 Placebo-treated subjects
reported an average reduction in CQ7 score of
-27% and -20% in the two studies. This range
of CQ7 score reductions was smaller than the
average CQ7 score reduction reported in Study
2 (-44%), indicating that ClearUP eectiveness
is above and beyond a placebo eect.

13
Consult your physician for safety of use if you have
implanted electrostimulation devices including a
pacemaker, a DBS (Deep Brain Stimulation) device,
hearing or visual implant devices (e.g., cochlear implant,
auditory brainstem implant, retinal prostheses).
Consult your physician if you have active (powered)
implanted metallic devices in the treatment path (i.e.
cheek, nose, and brow bone).
Do not use if you currently have abnormal cranial nerve
or other neurological findings or symptoms that would
require prompt medical attention.
Do not use if the device enclosure or tip is damaged.
Do not use if metal components are hot to the touch.
Do not alter the device.
Stop device use and consult your physician if you
experience any discomfort, increased pain, or any adverse
reaction.
If you have had medical or physical treatment for your
pain, consult with your physician before using this device.
If you have suspected or diagnosed heart disease,
you should follow precautions recommended by
your physician.
Care should be taken to apply simulation in the
presence of electronic monitoring equipment including
cardiac monitors and ECG alarms due to potential
The ClearUP Sinus Pain Relief unit is a rechargeable,
battery-operated device for adults 18 years of age
and older. Please read the warnings and cautions
before use as they are intended to keep you safe,
free of injury, and avoid a situation where the device
would be damaged.
ClearUP Sinus Pain Relief is an over-the-counter
treatment to be used at home by adults suering
from pain as a result of allergic rhinitis or with
moderate to severe congestion.
Safety Information
Warnings

14
electromagnetic interference.
Actively monitor your treatment and remove probe tip
from the treatment location if there is discomfort or
muscle twitching of the eye.
Do not use device if the Comfort Level Lights
continually flash. This indicates a fault in the device.
Contact us at [e-mail] or
call 1-888-276-6888.
Use as Directed.
Do not use if the skin is broken or on a wound of any kind.
As appropriate, wipe o the tip of device with wet wipes
before each use. Do not immerse in any fluid.
Avoid contact with facial piercings or metal jewelry.
Do not use in a bathtub, shower or steam room.
Do not use the device while charging.
Do not use if you experience any unusual skin sensitivity.
Keep out of reach of children.
Follow manufacturers’ recommendations for using
portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
for any limitations of use due to potential degraded
equipment performance.
Do not use device near active high frequency (HF) surgical
equipment or in the radio frequency (RF) shielded room
of a Magnetic Resonance Imaging (MRI) scanner or near
RF emitting equipment.
Use of cables other than those specified or provided by
the manufacturer of the device could result in increased
electromagnetic emissions or decreased electromagnetic
immunity of the device and result in improper operation.
Only use the manufacturer charger provided to avoid
damage to the unit.
The safety of electrical nerve stimulation during pregnancy
or delivery has not been established.
Cautions

15
Symbols and Definitions
A type BF applied
part complying
with IEC 60601-1
Consult instructions
for use
Product complies
with applicable
European Union
regulations.
The temperature
limits to which the
medical device can
be safely exposed.
The electronic device
is certied and the
electromagnetic
interference from
the device is under
the limits that are
approved by Federal
Communications
Commission.
Product should not
be disposed of in
a landll; the black
bar indicates that
the equipment was
manufactured after
2005
Protected against
solid objects over
12.5mm (e.g., a
nger) and protected
against falling drops
of water, if the case
is disposed at any
angle up to 15
degrees from vertical
Medical Device.
Recyclable
The unit contains a Lithium-ion battery. Dispose of the
unit according to local regulations for products containing
Lithium-ion batteries. Do not incinerate.

16
Unpacking Instructions
Charging Instructions
User Controls and Indicators
Remove the ClearUP® Sinus Pain Relief unit from its
packaging and inspect for damage. The package
should include the following:
Place the connector from the charger into the
charging port at the bottom of the unit. Insert the
wall charger plug into a power outlet. The unit is
disabled for safety while charging. The unit is fully
charged when the battery light turns solid green.
Don’t forget to charge unit before first time use.
Getting Started
• ClearUP Sinus
Pain Relief unit
• Charger
• User Guide
• Quick Start Guide
Press to turn ON. Press and hold to turn OFF.
Press briefly to change Comfort Level.
When the unit is on and the contact pressure is
sucient the contact indicator light will turn green.
Power Button
Contact Indicator

17
Getting Started
Press power button briefly to change levels.
When the battery level is low and needs
charging, the Battery Light turns on and will
blink orange. While charging, Battery Light
turns green and will pulse slowly, and the unit
will be disabled. When fully charged, Battery
Light will stay solid green until the unit is
unplugged from the charger.
Comfort Levels
The unit guides you to your unique facial
treatment points. The unit starts to vibrate
when it has detected a treatment point. When
it stops vibrating, continue to glide until the
unit detects the next treatment point.
Vibration Action of the Unit
Battery Light
Metal Tip
Contact
Indicator
Power
Button
Charging Port
Battery Light
Comfort
Level Lights
Return
Electrode
Level 1 Level 3Level 2

18
Unit will run a self-test and the
Contact Indicator and Comfort
Level Lights ash. At the end of
the self-test, only the Comfort
Level Light(s) stay on.
The difference in levels does not impact effectiveness.
Basic Operating Instructions
Start on the outside of your cheekbone.
Place the metal tip on your face using mild pressure.
Press Power Button briefly to change levels.
Unit defaults to Level 1. Adjust according to your
comfort.
Level 1 Level 3Level 2
Comfort Levels
Contact
Indicator
Comfort
Level
Lights
Power
Button
Turn unit on. Press Power
Button for ON. Press and
hold for OFF.
Glide the tip VERY
SLOWLY inward along the
cheek toward the nose.
STOP gliding
when unit vibrates.
If device does not vibrate, see
troubleshooting tips.
STOP
1
Hold unit with thumb and forefingers and put
metal tip in contact with your skin (about a 90
degree angle.)

19
Repeat.
Treat both sides of the face and then concentrate
on areas of pain.
Exact treatment points may vary.
The total treatment time is 5 minutes.
Unit vibrates when it nds a
treatment point.
HOLD TIP ON
TREATMENT POINT
until vibration stops.
Once vibration stops
GLIDE SLOWLY along
the cheek moving
towards the nose, up
and under the brow
to locate additional
treatment points.
5
min
1
2

20
Frequently Asked
Questions
How many treatment points should I
expect to find?
The device vibrates but I don’t feel any
current. Is it working?
Sometimes the sensation is stronger than
others. What should I do?
How long does relief last after treatment?
What is a “Comfort Level”?
How often should I use ClearUP?
What does it feel like?
Most people will find 7-10 treatment points on each
side of the face. The number of treatment points may
vary from person to person and from day to day.
Yes. It’s okay if you don’t feel anything. Microcurrent
waves are working if the device lights are on and the
unit is vibrating.
If you find a point is uncomfortable, move the device
tip slightly away or change the Comfort Level.
Relief can last up to 6 hours.
There are 3 levels. When first turned on, the unit
defaults to Level 1. Try the unit on Level 1. Adjust
according to your comfort level. The dierence in
levels does not impact eectiveness.
Use the device consistently 2-4 times a day for 2-4
weeks for maximum eectiveness. Users report a
reduction in severity of symptoms with regular use.
Some users feel no sensation other than the
vibration that indicates a treatment point has been
detected. Some feel a slight pricking, tapping, or
tingling sensation.