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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

Содержание ClearUP Sinus Pain Relief

Страница 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 ...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

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