Cala Health Cala Trio CT1-STR Health Care Professional Manual
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Summary of Contents for Cala Health Cala Trio CT1-STR
- 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...
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Page 2: Table Of Contents
CT1-RBS 875 Mahler Road, Suite 168 Burlingame, CA 94010 Disclaimer: Cala Health, Inc. and its affiliates shall not be liable 888-699-1009 for any injury or damage suffered by any person, either directly or indirectly, as a result of the unauthorized use or repair of Cala www.CalaHealth.com... -
Page 3: List Of Symbols
Use by date LIST OF SYMBOLS Protected against intrusion from fingers and small objects, and from water drops vertically falling on Cala Trio when it is tilted IP22 up to 15 ̊ from vertical. Do not immerse in a bathtub or use while swimming. Caution Cala Trio is rated for these temperature Refer to instructions for use. -
Page 4: Introducing Cala Trio
2 .0 INTRODUCING Cala Trio™ View instructional videos at my.CalaTrio.com 2.1 Indications for Use Cala Trio is indicated to aid in the transient relief of hand Base tremors in the treated hand following stimulation in adults Station with essential tremor (ET). •... -
Page 5: Safety Information
• Do not apply the device near the thorax, as this may increase the risk of arrhythmia. • Do not apply stimulation over open wounds or rashes, SAFET Y INFORMATION or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.). -
Page 6: Adverse Reactions
Should any technical problem occur that is not covered device in the original packaging when not in use or in the Healthcare Professional Guide or the Patient being charged. Guide, please contact Cala Health at 888-699-1009 or CustomerSuccess@CalaTrio.com. • To prevent damage to the device and/or performance issues: 3.4 Adverse Reactions... -
Page 7: Prescribing Cala Trio
4.3 Determining “Tremor Task” 4 .0 The “Tremor Task” is a postural hold that helps characterize the patient’s tremor. It is integral to the PRESCRIBING Cala Trio™ therapy as the patient will perform the hold: • during setup to define the patient’s baseline tremor before starting therapy and to calibrate the individualized therapy. -
Page 8: Setting Up Cala Trio
SETTING UP Cala Trio™ View instructional videos at my.CalaTrio.com Setting up Cala Trio is as simple as 1, 2, 3... 1. Positioning and fastening it on your wrist Step 2: Insert your prescribed hand through the band making sure the MAIN button points toward the 2. -
Page 9: Calibrating Cala Trio
• Should be snug enough so it does not slide along or around the wrist. Left Handed Right Handed Device Device Step 2: From Cala Trio, press and hold the MAIN button for 3 seconds to start setup. You will see "press main to measure 1"... -
Page 10: Setting Therapy Intensity
Step 7: Once Measure 1 is saved, Cala Trio will prompt you for Measures 2 and 3 • Repeat the same process for Measures 2 and 3. Note: If you accidentally save a poor measurement (e.g. you were walking or talking during the "Tremor Task"), reset Cala Trio by pressing and holding the UP and MAIN buttons simultaneously for 3 seconds. -
Page 11: A Therapy Session With Cala Trio
A THERAPY SESSION WITH Cala Trio™ View instructional videos at my.CalaTrio.com Step 5: After collecting your "Tremor Task", Cala Trio will ask if you want to start therapy. Press the MAIN button to start therapy A therapy session with Cala Trio is easy to start and fit into your day. -
Page 12: How To Stop Cala Trio Therapy
™ ™ 6.1 How to Stop Cala Trio Therapy 6.3 How to Remove Cala Trio AVOID REMOVING Cala Trio DURING THERAPY After 40 minutes, Cala Trio Therapy will automatically stop when the countdown timer reaches zero minutes and Between sessions, you can remove Cala Trio by: Cala Trio displays “therapy complete”. -
Page 13: Caring For Cala Trio
CARING FOR Cala Trio™ View instructional videos at my.CalaTrio.com Step 2: Remove the used band by unsnapping it from the stimulator ™ 7.1 How to Charge Cala Trio Step 3: For the new one, align the half circle cut outs on Charge Cala Trio the back of the band and stimulator as you snap •... -
Page 14: How To Recalibrate Cala Trio
™ ™ 7.4 How to Recalibrate Cala Trio 7.5 How to Reset Cala Trio In order to ensure effective therapy, or if the device If Cala Trio is frozen or otherwise performing in a way that is calibrated incorrectly Cala Trio may need to be you do not expect, you may perform a reset. -
Page 15: Troubleshooting
Step 7: Restart therapy. If warning persists, stop using Replace band as soon as possible. Therapy will not be Cala Trio and contact Cala Health at 888-699- available until a new band is attached. See section 7.2 on 1009 or CustomerSuccess@CalaTrio.com page 13 for directions on disconnecting and connecting the stimulator and band. -
Page 16: Clinical Study Summary
3. Suspected or diagnosed epilepsy or other seizure disorder 4. Pregnant CLINICAL STUDY SUMMARY 5. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site 6. Peripheral neuropathy affecting the tested 9.1 Study Overview upper extremity The study was multi-center, prospective, randomized, double-blinded, and sham-stimulation controlled. - Page 17 • » TETRAS Archimedes Spiral Task Additional Exploratory Analyses: The TETRAS Archimedes Spiral Task requires » Bain & Findley ADL Scale subjects to copy a spiral drawing in a 10-cm sized To thoroughly document tremor severity, the square. At baseline, the investigator rated the spiral. complete 25-item scale was administered at baseline.
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Page 18: Protocol
» Responder Rate 9.6 Statistical Analysis Plan (SAP) Additionally, the responder rate by therapy • Analysis populations allocation, was calculated for each of the TETRAS » The primary and secondary effectiveness endpoints tasks, where the responder rate was defined as the were assessed on the Effectiveness Analysis percentage of subjects with a ≥... - Page 19 Screened TABLE 3 (n=111) Baseline characteristics of Effectiveness Analysis Population (N = 77) Screen Failures (n=18) Overall Treatment Sham (N=77) (N=40) (N=37) Enrolled and Randomized (n=93) Age of onset in years Treatment Sham Mean (SD) 38.8 (21.2) 40.2 (21.7) 37.2 (20.7) (n=48;...
- Page 20 on average had moderate tremors, as demonstrated greater than the improvement in the sham group (p = by an average baseline Bain & Findley ADL total score 0.263). Therefore, the primary effectiveness endpoint was of 45.4 (out of 100), an average baseline upper-limb not met.
- Page 21 Additional Effectiveness Analyses ratings corresponding to moderate tremor. During stimulation, the spiral rating was 2.58 in the » Change in TETRAS Upper Limb Tremor Tasks treatment group and 2.26 in the sham group. During Both the treatment and sham groups improved across stimulation, the treatment and sham groups improved all 3 tasks during and after stimulation.
- Page 22 TABLE 11 TABLE 12 Change in ADLs after stimulation (EAP; N=77) TETRAS Spiral responder rate during and after stimulation (EAP; N=77) Treatment During Stimulation After Stimulation Baseline mean Change mean ± SD ± SD Responder Rate Responder Rate (95% CI) (95% CI) Use a spoon to drink 3.18 ±...
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Page 23: Adverse Events
9.8 Adverse Events TABLE 14 Adverse Event Rates No Serious Adverse Events (SAEs) or Unanticipated Treatment Sham Adverse Device Effects (UADEs) were reported. Of the All (N=93) (N=48) (N=45) 93 enrolled subjects, there were 4 non-serious adverse events amongst 3 subjects. The 4 adverse events were Any adverse event 3.2% (3) 4.2% (2) -
Page 24: Benefit/Risk Discussion
9.10 Benefit/Risk Discussion The risks of the device are based on nonclinical laboratory studies as well as data collected in the clinical study described above. Three percent (3/93) of enrolled subjects experienced 4 non-serious adverse events (one subject reported 2 AEs.) The 4 adverse events were mild, anticipated, and resolved within 24 hours without any intervention or sequelae, specifically, weakness, skin irritation, and pain (reported in a sham patient). -
Page 25: Technical Specifications
POWER 10.0 Permanent rechargable battery, Battery Type TECHNICAL SPECIFICATIONS not serviceable or replaceable AC 50/60 Hz Power Source Rated Voltage: 100-240V Max Current: 0.5 A THER APY SESSION Fully charged battery lasts 5 Duration Time 40 min per session therapy sessions Start Therapy Press MAIN button on therapy display ELEC TRODES... -
Page 26: Electromagnetic Compatibility Declaration
GENERAL RADIO COMPLIANCE 11.0 ITEM SPECIFICATION ELECTROMAGNETIC COMPATIBILIT Y Stimulator FCC ID: 2AA9B05 DECL ARATION Bluetooth Radio Frequency 2402 MHz to 2480 MHz (RF) Range Base Station FCC ID: 2AT2D-BASE0017 Cala Trio Stimulator claims compliance for electromagnetic compatibility in conjunction with Cala Radio Frequency 13.56 MHz Trio Base Station. - Page 27 GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNIT Y ELECTROMAGNETIC IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ENVIRONMENT GUIDANCE Voltage Dips 30% reduction, 25/30 periods Voltage Dips 30% reduction, 25/30 periods At 0° At 0° Mains power quality should be that of a typical commercial or hospital Voltage Dips >...
- Page 28 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND Cala Trio Cala Trio is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Cala Trio can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Cala Trio as recommended below, according to the maximum output power of the communications equipment.
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Page 29: Warranty Information
12 .0 WARRANT Y INFORMATION Cala Health, Inc. (“Cala”) warrants, to the original purchaser only, that the Cala Trio 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... - Page 30 Questions about Cala Trio? Visit CalaTrio.com/HCPFAQs LBL-5122 Rev C NOV 2019...