Tivic Health ClearUP Sinus Pain Relief User manual

USER’S GUIDE
Manufactured and distributed by:
Tivic Health Systems Inc., Menlo Park, CA 94025
Patented Technology
This product is for adults only.
All Rights Reserved
© Copyright 2020 Tivic Health Systems Inc.
Questions?
Tivichealth.com
[email protected]
1-888-276-6888
MKT-022A
tivichealth.com

1 year warranty
Go to tivichealth.com
Questions? 1-888-276-6888
Mon-Friday 9-6 CST
Email: [email protected]
Your satisfaction is important!
Introduction ........................................................4 - 5
How It Works............................................................6
Powerful Clinical Study Results............................7
Safety Information ......................................... 8 - 11
Symbols.................................................................. 11
Getting Started..............................................12 - 13
Unpacking.............................................................. 12
Charging Instructions.......................................... 12
User Controls and Indicators ............................. 13
Basic Operating Instructions......................14 - 15
Frequently Asked Questions ......................16 - 17
Maintenance.......................................................... 17
Troubleshooting.................................................... 18
Specications........................................................ 19
Electromagnetic Compatibility ...............................
(EMC) Information....................................20 - 24
Warranty and Customer Service ...............25 - 27
Table of Contents
Welcome to Our Community!

54
Introduction Intended Use
ClearUP Sinus Pain Relief is to be used for
the temporary relief of sinus pain associated
with Allergic Rhinitis. 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 to name a few.
Symptoms include sneezing, congestion,
runny nose, watery eyes, itching of the nose
or roof of the mouth, coughing and sinus pain.
Sinus pain can make you miserable. You never
know when your frustrating allergies are going
to flare-up.
Sinus medications, sprays and flushes don’t get
rid of your sinus pain … you’ve probably had no
good solutions … until now.
ClearUP®is different. It’s advanced microcurrent
technology that targets the sinuses for fast pain
relief. ClearUP is the only treatment that clears
up ALLERGY-RELATED SINUS PAIN without
drugs or chemical side effects.
It’s a game-changing sinus pain treatment that:
• Targets the pain
• Gives you sinus pain relief control
• Is 100% DRUG-FREE
• Frees you to feel better, be your best

76
ClearUP works in several ways.
• Microcurrent is emitted from the tip of the unit
to the nerves under the facial sinus passages.
• Electrical stimulation of nerves reduces feelings
of sinus pain for up to 6 hours according to our
clinical study.
(This study has not been reviewed by the FDA)
• 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
Note: ClearUP must be self-administered and cannot be applied to
another person. This is due to the electrical circuit design.
How It Works
Pivotal Clinical Study: A top-tier U.S. science
research center conducted a double-blinded,
randomized controlled clinical study using the
ClearUP Sinus Pain Relief device. Included were
27 sinus pain subjects with Chronic Rhinosinusitis,
49 patients suffering from Allergic Rhinitis, 5 subjects
with other sinus conditions. Each subject used the
device on the outside of their sinus passages without
any assistance for a single ve-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.
Post-market clinical study: Conducted at the
Asthma Allergy Associates in Santa Clara, CA,
subjects received a ve-minute treatment in ofce,
followed by 4 weeks of at-home use.
(This study has not been reviewed by the FDA).
Powerful Clinical Study Results
74%
3 out of 4 got relief
82%
43%
preferred ClearUP
reduction in sinus
pain after 4 weeks
Up to 6 hrs pain relief
would recommend
ClearUP
6
hours
Two key clinical studies and FDA clearance demonstrated
that ClearUP is a safe and effective treatment.
77%
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.

98
The ClearUP Sinus Pain Relief unit is a
rechargeable, battery-operated unit for adults 18
years of age and older. Please read the warnings
and cautions before use. They are intended to
keep you safe, free of injury and avoid a situation
where the device would be damaged.
Contraindication
Do not use if you have implanted
electrostimulation devices including a pacemaker,
a DBS (Deep Brain Stimulation device) or a
cochlear implant.
Do not use if you have 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 ndings or symptoms
that would require prompt medical attention.
Warnings
Do not use if the unit enclosure or tip is damaged.
Do not use unit if the Treatment Level light is
continually flashing. This indicates a device fault.
Contact Customer Service.
Do not use if metal components are hot to
the touch.
Do not alter the unit.
Safety Information
Stop 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.
Do not apply stimulation in the presence of
electronic monitoring equipment (e.g. cardiac
monitors, ECG alarms) because it may disrupt
the proper operation of the equipment.
Cautions
Do not use while pregnant because the safety
of electrical nerve stimulation during pregnancy
or delivery has not been established.
Do not use if the skin is broken or on a wound of
any kind.
Do not insert unit into the nose or inside any
other body part.
Do not put the unit directly on or in your eyes
or ears, on your neck, or on any body part not
indicated.
Recommend wiping the device with alcohol wipes
prior to each use. Do not immerse in any fluid.

1110
Do not use if wearing facial piercings or
metal jewelry.
Do not use in a bathtub, shower or steam room.
Do not use in a moving vehicle.
Do not use unit while charging since unit is
disabled during charging.
Do not use if you experience any unusual skin
sensitivity such as exaggerated writing on the skin
when the skin is stroked.
Keep out of reach of children and store it safely
away from children.
Portable RF communications equipment (including
peripherals such as antenna cables and external
antennas, security systems, cell phones) should
be used no closer than 30 cm (12 inches) to any
part of the ClearUP unit including cables specied
by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Do not use unit if it shuts down or the performance
has degraded in any way.
Do not use unit near active HF surgical equipment
or in the RF shielded room of an MRI scanner or
near RF emitting equipment such as diathermy and
electrocautery & RFID because it could result in
improper operation.
Safety Information
Cautions, continued Use of the unit adjacent to or stacked with
other equipment should be avoided because it
could result in improper operation. If such use
is necessary, the unit and the other equipment
should be observed to verify that they are
operating normally.
Use of cables other than those specied or
provided by the manufacturer of the unit could
result in increased electromagnetic emissions or
decreased electromagnetic immunity of the unit
and result in improper operation.
Symbols
Type BF
Applied Part
Consult
instructions
for use
Electromagnetic
interference from
the device is under
limits approved
by theFederal
Communications
Commission
Dispose of battery
according to local
regulations for a
Lithium coin cell
battery. Do not
put in garbage.
Protection against
vertically falling
drops of water, if the
unit is tilted at 15
degrees. Protection
from a large part of
the body such as
a hand; from solid
objects greater than
50mm in diameter.
An item that is
known to pose
hazards in all MR
environments,
including magnetic
items such as a pair
of ferromagnetic
scissors.
Recyclable

1312
Unpacking Instructions
Remove the ClearUP®Sinus Pain Relief unit from
its packaging and inspect for damage. The package
should include the following:
Warning! Do not use if the device enclosure or
tip is damaged.
Getting Started
Vibration action of the unit
The unit guides you to your unique facial treatment
points. The unit will vibrate for 7 seconds when it
has detected a treatment point. When it stops
vibrating, move to the next treatment point.
Battery Light
When battery is low and needs charging, the
orange Low Battery Light will blink. While
charging, Low Battery Light will pulse slowly and
the unit will be disabled. When charged, Battery
Light will be solid green.
Level 1 Lights Level 3 LightsLevel 2 Lights
User Controls and Indicators
Power Button
Press to turn ON. Press and hold to turn OFF.
Press briefly to change Treatment Level.
Contact Indicator
Green light will light up when unit is in good
contact with your skin.
• ClearUP Sinus
Pain Relief unit
• Wall Charger
• User Guide
• Quick Start Guide
Charging Instructions
Don’t forget to charge unit before rst time use.
Place the connector from the charger into the
charging port at the bottom of the unit
Tip: Ensure that the cap on the connector tip is
pushed “IN”.
Insert the wall charger
plug into a power outlet.
Unit cannot be used while
charging.
Unit is fully charged when
the battery light
turns GREEN.
Caution: Use only the wall
charger provided to avoid damage to unit. The unit is
disabled and cannot be used during charging.
Tip: Before each use, prep the area. Remove glasses
and heavy oils, lotions, or makeup, and metal jewelry
and facial piercings.
Treatment Levels
Metal Tip
Contact
Indicator
Power
Button
Charging Port
Battery Light
Treatment
Level Lights
Push In Correct
Return
Electrode

1514
Step 1
Turn Unit on. Press Power Button
for ON. Press and hold for OFF.
(Unit will run a self-test by
flashing the Contact Indicator
and Treatment Level Lights.).
Step 3
Repeat gliding and holding while unit vibrates.
Start at the outside of your cheekbone, move inward
along the cheek, move to the nose and then under
brow bone. (See the path in photo on the right.)
Treat both sides of the face for 5 minutes total time.
Relief will last up to 6 hours. Exact treatment points
will vary by person and per treatment.
Basic Operating Instructions
START ON YOUR CHEEKBONE and move inward.
POWER
BUTTON
Press Power Button briefly to change levels.
Unit defaults to LEVEL 1. Start your rst treatment in
LEVEL 1. Adjust according to your comfort.
Warning! Do not use device if the Treatment Level Lights continually flash.
This indicates a fault in the device. Contact us at
[email protected] or call 1-888-276-6888.
Step 2
Level 1 Lights Level 3 LightsLevel 2 Lights
Treatment Levels
Hold device with thumb and forengers and put metal
tip in contact with your skin (about a 90 degree angle.)
Unit vibrates when it
nds a treatment point.
HOLD TIP ON
TREATMENT POINT
until vibration stops.
Glide tip VERY SLOWLY
along cheek.
STOP gliding when
unit vibrates.
If device does
not vibrate, see
troubleshooting tips.
GLIDE SLOWLY to
locate next point.
Repeat and follow
paths on Step 3.
1
1
2
STOP

1716
Frequently Asked Questions
How many treatment points should I expect to nd?
Most people will nd 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.
What is a “Treatment Level”?
There are 3 levels. When rst turned on, the
device defaults to LEVEL 1. Try the device on
LEVEL 1. Briefly press the power button to change
the Treatment Level. Adjust according to your
comfort level.
What does it feel like?
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.
The device vibrates but I don’t feel any current.
Is it working?
Yes. It’s okay if you don’t feel anything. Microcurrent
waves are working if unit is vibrating.
Sometimes the sensation is stronger than others.
What should I do?
If you nd a point is uncomfortable, move the device
tip slightly away. Discomfort should stop.
How often can I use it and how long does it last?
Use when symptoms are present. Customers have
reported using it once in the morning and again
before bed. Each treatment can last up to 6 hours per
our research.
Should I use it once in a while or regularly? We
recommend using it at least 2 times/day for 2-4
weeks for maximum effectiveness. Users report both
a reduction in severity and frequency of symptoms
with regular use.
How long should I use ClearUP®Sinus
Pain Relief in a single treatment?
For 5 minutes total time. Begin with treating both sides
of the face. Next, concentrate on areas of greatest pain.
Are there any side effects?
Unlike medications, there are no chemical side
effects. A small percentage of users (less than 5%)
may experience mild brief skin irritation.
Maintenance
Wipe the tip and body down with alcohol wipes.
Allow the device to dry before using. Store in a
cool, dry place.
Caution: Do not immerse in any fluid. In the event
of a spill on the unit, wipe the device completely
dry before using again.
Caution: Do not open. Unit contains no user
serviceable parts.
Caution: Unit contains a Lithium-ion coin cell.
Dispose of battery according to local regulations
for Li-ion battery disposal. Do not incinerate.

1918
Troubleshooting
Device does not
turn on
Connect wall charger to the unit and
charge the battery. Ensure that the
connector tip cap is pushed “in”
(see image on p.12).
Device Battery Light
does not turn on
when charger is
attached
Check that wall charger is
plugged into a working outlet.
Contact Indicator
Light does not turn
on when unit is in
contact with face
Remove heavy makeup or lotions.
Make sure metal tip is in
contact with the skin.
Lightly moisten skin with water.
Check that the electrode tip is clean.
Make sure hand is in contact with
metal part of unit, marked as
Return Electrode.
Unit does not
vibrate / detect any
treatment spots
Change Treatment Level by briefly
pressing and holding the power
button a second time and/or a third
time. There are 3 Treatment Levels.
Remove heavy makeup or lotions.
Lightly moisten skin with water. Check
that the electrode tip is clean.
Device is not
functional
Device may not operate properly in
the presence of microwave ovens or
high-power electronics. Move to a
location away from emission sources.
Treatment
Level Light
continually flashes
Stop use immediately. This indicates
a fault in the device. Contact
[email protected]
Or call 1-888-276-6888.
The device lights up
and vibrates
properly, but I
cannot feel the
treatment on the
skin.
The microcurrent waves are so low
that many users cannot feel the
current. It is still working.
In the event of
degraded
performance of the
unit or the device
lights and vibrations
are wavering or the
unit shuts down.
Stop use immediately and walk away
from cell phones, security systems,
any RF emitting equipment that may
be in the near vicinity.
Channel One
Output
Current Waveform: AC-coupled square wave Max Voltage at 500 ohms: +/-3V
Max Current Density at 500 ohms (at tip):
3.2mA / cm²
Waveform Continuous
Lights LED illumination of tip to indicate circuit
is complete and contact is sufcient for
treatment.
LED lights to show Treatment Level setting.
LED battery light for battery and charging
status.
Power Source Battery : Lithium-ion cell, +3.7V @ .3AH,
safety PCB
Operating
Temperature +10ºC to +40ºC (50ºF to 104ºF)
Storage
Temperature -20ºC to +60ºC (-4ºF to 140ºF)
Operating/
Storage
Relative
Humidity
15% to 90% (non-condensing)
Operating/
Storage Atm
Pressure
500-1060 kPa
Dimensions Approximately L85xW45xH25 (mm) or
L3.3xW1.8xH1 (inch)
Weight Approximately 55 grams
Specications
Specications are nominal and subject to variation from the
listed values due to normal production tolerances.

2120
IEC 60601-1-2 Clause 5 Location in Instruction
for Use (User Guide)
5.1 Specied Type of Shielded
Location N/A
5.2 Accompanying Documents
5.2.1 Instruction for Use Included
5.2.1.1 General
5.2.1.1 (a) Statement of
Environments
Page 19 (Specications
table)
5.2.1.1 (b) Essential
Performance
ClearUP Sinus Pain Relief
will deliver microcurrent of
a specic value.
5.2.1.1 (c) Warning Statement:
Use of device adjacent to or
stacked with other equipment
Page 11
5.2.1.1 (d) Adapter Cable with
non-shielded cable
N/A
5.2.1.1 (e) Warning Statement
of using other accessories and
cables.
Page 10-11
5.2.1.1 (f) Warning Statement
of using portable RF
communication equipment
N/A
5.2.1.2 Classied Class B
according to CISPR 11
Device meets CISPR 11
Class B limits
5.2.2 Technical Description Page 12-13
5.2.2.1 (a) Compliance to
Emissions and Immunity
Page 20-24
Electromagnetic Compatibility
(EMC) Information
IEC 60601-1-2 Clause 5 Location in Instruction
for Use (User Guide)
5.2.2.1 (b) Deviation from
collateral standard and
allowances used
N/A
5.2.2.1 (c) All Necessary
Instruction for maintaining
Basic Safety and Essential
Performance
Page 8-11
5.2.2.2 (a) Warning Failure
to use equipment in the
specied type of shielded
location
N/A
5.2.2.2 (b) Specications for
the shielding location
N/A
5.2.2.2 (c) Recommended
test methods for
measurement of RF shielding
N/A
5.2.2.2 (d) Recommendation
of equipment allowed inside
shielded location
N/A
5.2.2.3 ME equipment
intentionally receives RF
electromagnetic energy for
the purpose of its operation
N/A
5.2.2.4 ME equipment that
includes RF transmitters
N/A
5.2.2.5 (a) List of the
frequencies and modulations
used to test Immunity
A1) 380 - 390MHz –18Hz PM
(Pulse Modulation)
A2) 430 - 470MHz –1KHz
Sine, @ 80% AM
A3) 710, 745 & 780MHz –
217Hz PM
A4) 810, 870 & 930MHz –
18Hz PM
A5) 1720, 1845, 1970 & 2450
MHz - 217Hz PM
A6) 5240, 5500 & 5785MHz -
217Hz PM
5.2.2.6 ME Equipment that
claim compatibility with HF
Surgical equipment
N/A
Electromagnetic Compatibility
(EMC) Information

2322
Guidance and manufacturer’s
declaration-Electromagnetic emissions
Emissions
test
Compliance Electromagnetic
environment -
guidance
RF emissions
CISPR 11 Compliant Group 1, Class B
Harmonic
emissions
IEC 61000-3-2
Compliant
Voltage
fluctuations /
flicker emissions
IEC 61000-3-3
Compliant
The ClearUP®is intended for use in the
electromagnetic environment specied below. The
customer or the user of the ClearUP should assure that
it is used in such an environment.
Electromagnetic Compatibility
(EMC) Information
Guidance and manufacturer’s
declaration-Electromagnetic immunity
Immunity test Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge
(ESD) IEC
61000 - 4-2
Compliant +/- 8kV Contact, +/ 2kV,
+/- 4kV, +/- 8kV, +/- 15kV Air
Electrical
fast transient/
burst IEC 61000-
4-4
Compliant
+/-2 kV for power supply
lines +/-1kV for input/
output lines
Surge IEC 61000-
4-5 Compliant +/-1 kV differential mode
+/-2kV common mode
Voltage dips.
Short Interruptions
and voltage
variations on power
supply input lines
IEC 61000-4-11
Compliant
<5% Ut (>95% dip in Ut)
for 0.5 cycle, 40% Ut (60%
dipinUt) for 5 cycles ,
70% Ut (30% dip in Ut)
for 25 cycles, <5% Ut
(>95% dip in Ut) for 5 cycles
Power frequency
(50/60 Hz)
magnetic eld IEC
61000-4-8
Compliant 30 A/m
Conducted RF IEC
61000-4-6
Compliant 3 Vrms 150kHz to 80 MHz, 6 Vrms at ISM band
Radiated RF
IEC 61000-4-3 Compliant 3 V/m 80MHz to 2.7GHz
The ClearUP®is intended for use in the
electromagnetic environment specied below. The
customer or the user of the ClearUP should assure
that it is used in such an environment.
Electromagnetic Compatibility
(EMC) Information

2524
Recommended separation distance between
portable and mobile RF communications
equipment and ClearUP
The ClearUP®is intended for use in the electromagnetic
environment in which radiated RF disturbances are
controlled. The customers or the users of ClearUP
can help prevent electromagnetic interference by
maintaining a minimum distance between portable
and mobile RF communications equipment
(transmitters) and the ClearUP as recommended
below, according the maximum output power of the
communications equipment.
For transmitters rated at a maximum output power not
listed above, the recommended separation distance
din meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance
for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Separation distance according the
frequency of transmitter in meter
Output
Power of
Transmitter
in Watt
150 kHz to 80
MHz
d= 1.2 √P
80 MHz to
800MHz
d= 1.2√P
800MHz to
2.5GHz
d= 1.2√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.78
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
Electromagnetic Compatibility
(EMC) Information
Limited Warranty Coverage
Tivic Health Systems Inc. (“Tivic Health”) hereby
warrants that the ClearUP Sinus Pain Relief device
(“Device”) shall be substantially free from defects
in material and workmanship under normal use in
accordance with the User’s Guide supplied with
the Device, for a period of one (1) year from the
date of purchase. Tivic Health’s limited warranty
shall only extend to the original end user, where the
original end user purchased a new Device in sealed
packaging from Tivic Health or an authorized Tivic
Health seller. This limited warranty may not be
assigned or transferred. The terms of the Limited
Warranty in effect as of the date of original purchase
shall apply to any warranty claims.
LIMITED WARRANTY LIMITATIONS
This limited warranty does not cover defects or
damage of any sort resulting from accidents,
improper storage, wear, improper operation,
improper storage, mishandling, abuse, disassembly
or alterations, unauthorized service, tampering,
neglect, re, flood, war, or acts of nature.
Additionally, this limited warranty does not cover
damage of any sort resulting from the use of the
Device with any charger other than the original
charger which was packaged with the Device (or
any replacement provided by Tivic Health).

2726
Limited Warranty Coverage
EXCLUSIVE REMEDY
If any Device fails to meet the foregoing warranty
within the applicable warranty period, Tivic Health
shall have the option, as selected at Tivic Health’s
sole discretion, to repair, replace, or provide a credit
to the original end user. In the event of replacement,
Tivic Health shall have the right at its sole discretion to
replace the Device with a new, or refurbished, Device.
In no event, shall the limited warranty period of a
replacement Device extend past the limited warranty
period of the Device it is replacing.
WARRANTY SERVICE
In order to obtain warranty service, contact
Tivic Health customer service for instructions. In the
event an item must be returned, a Return Material
Authorization (RMA) number is required. Items
returned without an RMA number will not be accepted.
The item shall be shipped at the original end user’s
expense to a destination specied by
Tivic Health.
OBLIGATIONS AND WARRANTY LIMITS
EXCEPT FOR THE LIMITED WARRANTY SET FORTH ABOVE,
TIVIC HEALTH MAKES NO OTHER WARRANTIES AND
DISCLAIMS ALL OTHER REPRESENTATIONS, GUARANTIES,
CONDITIONS, AND WARRANTIES CONCERNING THE DEVICE,
WHETHER DIRECT OR INDIRECT, EXPRESS OR IMPLIED, OR
ARISING UNDER ANY STATUTE, ORDINANCE, COMMERCIAL
USAGE OR OTHERWISE, INCLUDING WITHOUT LIMITATION
ANY WARRANTY OR REPRESENTATION AS TO FITNESS
FOR PURPOSE, DURABILITY, DESIGN, MERCHANTABILITY,
OR CONDITION OF THE DEVICE (OR ANY PART THEREOF),
OR RELATING TO THE INFRINGEMENT OF ANY PATENT,
COPYRIGHT, OR OTHER PROPRIETARY RIGHT USED OR
INCLUDED THEREIN.
ALTHOUGH THE DEVICE IS APPROVED FOR SALE BY THE FDA
FOR THE TEMPORARY RELIEF OF SINUS PAIN ASSOCIATED
WITH ALLERGIC RHINITIS, THE RESPONSE AND EFFICACY
WILL VARY BASED ON THE USER’S PHYSIOLOGY AND
OTHER VARIABLE FACTORS AND TIVIC HEALTH MAKES
NO WARRANTY THAT ANY SPECIFIC RESULTS WILL BE
ACHIEVED THROUGH THE USE OF THE DEVICE OR THAT
ANY RELIEF FROM SINUS PAIN WILL BE ACHIEVED AND ALL
SUCH WARRANTIES ARE HEREBY EXPRESSLY DISCLAIMED.
IF ANY IMPLIED WARRANTIES APPLY AS A MATTER OF LAW,
THEY ARE LIMITED IN DURATION TO THE LENGTH OF THIS
LIMITED WARRANTY. SOME STATES MAY NOT RECOGNIZE
A DISCLAIMER OR LIMITATION OF WARRANTIES AND/ OR
LIMITATION OF LIABILITY SO THE ABOVE DISCLAIMER AND
EXCLUSIONS MAY NOT APPLY. THE ORIGINAL END USER MAY
ALSO HAVE DIFFERENT AND/OR ADDITIONAL RIGHTS AND
REMEDIES THAT VARY FROM STATE TO STATE.
THE ORIGINAL END USER ACKNOWLEDGES AND AGREES
THAT TIVIC HEALTH SHALL NOT BE RESPONSIBLE FOR ANY
DAMAGES THAT THE ORIGINAL END USER MAY INCUR FROM
DELAYED SHIPMENT, DEVICE FAILURES, OR FROM ANY OTHER
CAUSE, WHETHER LIABILITY IS ASSERTED IN CONTRACT,
TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT
LIABILITY) OR OTHERWISE. IN NO EVENT SHALL TIVIC HEALTH
BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL
OR SPECIAL DAMAGES OF ANY KIND (INCLUDING WITHOUT
LIMITATION LOSS OF PROFITS OR LOSS OF USE), WHETHER OR
NOT TIVIC HEALTH SHALL BE OR SHOULD BE AWARE OF THE
POSSIBILITY OF SUCH POTENTIAL LOSS OR DAMAGE.
REPRESENTATIONS AND WARRANTIES MADE BY ANY
PERSON, INCLUDING BUT NOT LIMITED TO DISTRIBUTORS,
REPRESENTATIVES, SALESPERSONS, OR AGENTS OF TIVIC
HEALTH, WHICH ARE INCONSISTENT OR IN CONFLICT WITH
OR IN ADDITION TO THE TERMS OF THIS LIMITED WARRANTY,
SHALL NOT BE BINDING UPON TIVIC HEALTH UNDER ANY
CIRCUMSTANCE.
THIS LIMITED WARRANTY IS THE COMPLETE AND EXCLUSIVE
STATEMENT OF WARRANTY WHICH TIVIC HEALTH AGREES
TO PROVIDE WITH RESPECT TO THE DEVICE AND IT SHALL
SUPERSEDE ALL PRIOR AND CONTEMPORANEOUS ORAL OR
WRITTEN AGREEMENTS, UNDERSTANDINGS, PROPOSALS,
AND COMMUNICATIONS PERTAINING TO THE SUBJECT
MATTER HEREOF.
For questions: tivichealth.com
Call: 1-888-276-6888
Email: [email protected]