Cala Health Cala Trio CT1-BLL, Health Care Professional Manual

Page 1: ...HEALTH CARE PROFESSIONAL GUIDE Caution Federal law restricts this device to sale by or on the order of a physician LBL 5122 Rev C NOV 2019...

Page 2: ...la Trio 12 7 0 Caring for Cala Trio 13 7 1 How to Charge Cala Trio 13 7 2 How to Replace Cala Trio Band 13 7 3 How to Change Stimulation Intensity Preset 13 7 4 How to Recalibrate Cala Trio 14 7 5 How...

Page 3: ...from fingers and small objects and from water drops vertically falling on Cala Trio when it is tilted up to 15 from vertical Do not immerse in a bathtub or use while swimming Cala Trio is rated for t...

Page 4: ...ef of hand tremor is desired i e before activities involving your hands such as meals or writing Cala Trio therapy is recommended for use at least twice daily to help with the activities listed above...

Page 5: ...ncrease the risk of arrhythmia Do not apply stimulation over open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc Do...

Page 6: ...n that lack normal sensation Keep out of the reach of children and pets The device is single patient use by the individual for whom it has been prescribed It should not be worn by anyone else or on an...

Page 7: ...subject s wrist circumference with a wrist measurement device measuring tape Measure over the wrist bone 2 Wrap the measuring tape around the wrist There should be no visible gaps between the measuri...

Page 8: ...on points toward the elbow not the hand Step 3 Center the stimulator on the back of your wrist as close to the hand as possible without hindering wrist movement Note Correct placement of the Cala Trio...

Page 9: ...p Cala Trio Step 1 Press the MAIN button to wake up the stimulator You should see Cala Trio displayed UP button DOWN button MAIN button Step 2 From Cala Trio press and hold the MAIN button for 3 secon...

Page 10: ...rs in the areas highlighted in the images above Note Tingling sensation varies depending on Cala Trio positioning and amount of water on the wrist You may feel a stinging sensation if you did not wet...

Page 11: ...postural hold To complete your Tremor Task You can find your Tremor Task in your prescription information Get in position to do your Tremor Task Press the MAIN button to start the measurement Note On...

Page 12: ...will ask you if your Tremor Task To rate how your tremor level has changed compared to before therapy Step 1 Press the MAIN button to bring up the rating display Step 2 Press UP button or DOWN button...

Page 13: ...handedness of the band matches your prescription information Step 2 Remove the used band by unsnapping it from the stimulator Step 3 For the new one align the half circle cut outs on the back of the b...

Page 14: ...to save If you do not want to save the calibration press DOWN and then MAIN to exit Cala Trio therapy is re calibrated and ready to use Step 2 Release the buttons and Cala Trio will automatically res...

Page 15: ...d the MAIN button for a few seconds to reset the stimulator Use stimulator as instructed If the error persists contact Cala Health at 888 699 1009 or CustomerSuccess CalaTrio com Charge Device Cala Tr...

Page 16: ...ic Thalamotomy Gamma Knife Radiosurgical Thalamotomy and focused ultrasound for the treatment of tremor 3 Suspected or diagnosed epilepsy or other seizure disorder 4 Pregnant 5 Swollen infected inflam...

Page 17: ...ssion The subject reported their improvement on the 7 point CGI I scale defined as follows 1 Very much improved 2 Much improved 3 Minimally improved 4 No change 5 Minimally worse 6 Much worse 7 Very m...

Page 18: ...ham or treatment and to the spiral order e g baseline during or after stimulation The independent blinded raters rated the spirals using the 5 point 0 4 TETRAS scale using a 0 5 point resolution The s...

Page 19: ...prior form of treatment for ET Subjects enrolled in the study TABLE 3 Baseline characteristics of Effectiveness Analysis Population N 77 Overall N 77 Treatment N 40 Sham N 37 Age of onset in years Mea...

Page 20: ...56 0 76 0 35 0 102 0001 0 263 Sham 36 0 39 0 60 0 17 0 108 0 0006 1 One of the 77 EAP subjects had missing post stimulation TETRAS Spiral rating data therefore the N for this analysis is 76 TABLE 6 Su...

Page 21: ...reatment 40 2 29 0 70 0 51 0 70 0 56 0 72 Sham 37 2 16 0 57 0 34 0 44 0 36 0 54 Kinetic Treatment 40 2 29 0 47 0 50 0 51 0 53 0 59 Sham 37 2 27 0 47 0 31 0 38 0 34 0 43 Upper Limb Total Treatment 40 6...

Page 22: ...After stimulation the responder rate was 27 5 compared to 16 7 in the sham group TABLE 12 TETRAS Spiral responder rate during and after stimulation EAP N 77 During Stimulation After Stimulation Respo...

Page 23: ...onitored by an independent Safety Reviewer who is a board certified neurologist and movement disorder specialist The Safety Reviewer could make recommendations for protocol modifications or trial disc...

Page 24: ...ile 27 5 had a 1 0 point improvement directly after 40 minutes of device use These differences are clinically meaningful The duration of the effect was not assessed beyond the assessments five minutes...

Page 25: ...ype Permanent rechargable battery not serviceable or replaceable Power Source AC 50 60 Hz Rated Voltage 100 240V Max Current 0 5 A Duration Fully charged battery lasts 5 therapy sessions MEASUREMENT A...

Page 26: ...nal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Cala Trio is suitable for use in all esta...

Page 27: ...output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as dete...

Page 28: ...um output power not listed above 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 powe...

Page 29: ...the Cala TrioTM that such customer purchased the Product shall be free from defects in materials and workmanship under normal use and will perform in accordance with the Product specifications set fo...

Page 30: ...30 Questions about Cala Trio Visit CalaTrio com HCPFAQs LBL 5122 Rev C NOV 2019...