background image

9

8

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 findings 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.     

Summary of Contents for ClearUP Sinus Pain Relief

Page 1: ...c 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 Customerservice tivichealth com 1 888 276 6888 MKT 022A tivichealth com ...

Page 2: ...ical 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 Specifications 19 Electromagnetic Compatibility EMC Information 20 24 Warranty and Customer Service 25 27 Table of Contents Welcome to Our Community ...

Page 3: ...ld 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 yo...

Page 4: ...ction 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 five minute treatment in office followed by 4 weeks of at home use This study has not been reviewed by the FDA Power...

Page 5: ...ice 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 rec...

Page 6: ...d 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 specified or provid...

Page 7: ... 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 first time use Place the connector from the charger into the charging port at the bottom of the unit Tip Ensure...

Page 8: ... Press Power Button briefly to change levels Unit defaults to LEVEL 1 Start your first 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 customerservice tivichealth com or call 1 888 276 6888 Step 2 Level 1 Lights Level 3 Lights Level 2 Lights Treatment Levels Hold devic...

Page 9: ...d 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 ...

Page 10: ...n the device Contact customerservice tivichealth com 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 a...

Page 11: ...nformation 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 specified type of shielded location N A 5 2 2 2 b Specifications for the shielding location N A 5 2 2 2...

Page 12: ... 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 Voltagedips ShortInterruptions andvoltage variationsonpower supplyinputlines IEC61000 4 11 Compliant 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dipinUt for 5 cycles 70 ...

Page 13: ... 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 1 1 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 acco...

Page 14: ...GY 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 DIS...

Reviews: