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26

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

ClearUP® is intended for use in the 
electromagnetic environment specified below. 
The customer or the user of ClearUP should 
assure that it is used in such an environment.

Summary of Contents for ClearUP

Page 1: ...User s Guide...

Page 2: ...Questions tivichealth com 1 888 276 6888 customerservice tivichealth com cursor phone email 1 year warranty Triple action drug free relief from allergy sinus pain sinus headaches and congestion...

Page 3: ...ons Getting Started Unpacking Charging User Controls and Indicators Basic Operation Instructions Frequently Asked Questions Maintenance Troubleshooting Specifications Electromagnetic Compatibility EMC...

Page 4: ...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...

Page 5: ...tions 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...

Page 6: ...te 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...

Page 7: ...lows 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 subcutane...

Page 8: ...t 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 compress...

Page 9: ...suffering 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...

Page 10: ...ent 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 t...

Page 11: ...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 d...

Page 12: ...tuffiness 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 tw...

Page 13: ...nce 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 diag...

Page 14: ...nce 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 exte...

Page 15: ...the limits that are approved by Federal Communications Commission Product should not be disposed of in a landfill the black bar indicates that the equipment was manufactured after 2005 Protected again...

Page 16: ...all 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...

Page 17: ...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...

Page 18: ...essure Press Power Button briefly to change levels Unit defaults to Level 1 Adjust according to your comfort Level 1 Level 3 Level 2 Comfort Levels Contact Indicator Comfort Level Lights Power Button...

Page 19: ...points may vary The total treatment time is 5 minutes Unit vibrates when it finds a treatment point HOLD TIP ON TREATMENT POINT until vibration stops Once vibration stops GLIDE SLOWLY along the cheek...

Page 20: ...ng 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 la...

Page 21: ...our full Shipping Returns Policy at tivichealth com or contact us by email at customerservice tivichealth com Unlike medications there are no chemical side effects A small percentage of users less tha...

Page 22: ...Follow instructions from Contact Indicator Light event from Troubleshooting Section Ensure metal portion of tip remains in contact with your skin during the treatment Change Comfort Level and try agai...

Page 23: ...attery light for battery and charging status Power Source Battery Lithium ion cell 3 7V 3AH safety PCB Operating Temperature 10 C to 40 C 50 F to 104 F Storage Temperature 20 C to 60 C 4 F to 140 F Op...

Page 24: ...a specific value 5 2 1 1 c Warning Statement Use of device adjacent to or stacked with other equipment Page 13 5 2 1 1 d Adapter Cable with non shielded cable N A 5 2 1 1 e Warning Statement of using...

Page 25: ...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 13 17 5 2 2 2 a Warning Failure to use equip...

Page 26: ...ance 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 ClearUP is intended for use in the electr...

Page 27: ...ge 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...

Page 28: ...ove the recommended separation distance d in 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 i...

Page 29: ...ll apply to any warranty claims This limited warranty does not cover defects or damage of any sort resulting from accidents improper storage wear improper operation mishandling abuse disassembly or al...

Page 30: ...tation 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 use...

Page 31: ...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...

Page 32: ...Patented Technology This product is for adults only 2022 Tivic Health Systems Inc All Rights Reserved The V logo and Tivic logo are trademarks of Tivic Health Systems Inc MKT 022D Questions tivichealt...

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