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Summary of Contents for Cala Health Trio
- Page 1 PATIENT GUIDE Caution: Federal law restricts this device to sale by or on the order of a physician LBL-5117 Rev C AUG 2019...
- Page 2 Burlingame, CA 94010 888-699-1009 www.CalaHealth.com Copyright (c) 2018, Cala Health, Inc. All Rights Reserved. Cala Health, Cala, and Cala Trio are trademarks of Cala Health, Inc., registered in the U.S. and other countries. Patent: CalaTrio.com/Patents Model: CTS100, CTB101, CTB102, CTB103, CTB104,...
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Page 3: Table Of Contents
Setting Therapy Intensity ............16 A Therapy Session with Cala Trio ........TABLE OF CONTENTS How to Stop Cala Trio Therapy ........21 How to Rate Your Tremor with Cala Trio .......21 How to Remove Cala Trio ........... Caring for Cala Trio ............ -
Page 4: List Of Symbols
Type BF Applied Part(s) Caution Manufacturer Refer to instructions for use. Contains electronic equipment Properly Date of manufacture dispose in accordance with local regulations. Complies with United States Product Use by date Safety Standards. Questions about Cala Trio? Visit CalaTrio.com/FAQs... - Page 5 Cala Trio is rated for these atmospheric and small objects, and from water drops pressure limits. For more information on 101k Pa vertically falling on Cala Trio when it is IP22 environmental parameters, refer to the 70kPa tilted up to 15 ̊ from vertical. Do not immerse Technical Specifications in this User Guide.
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Page 6: Introducing Cala Trio
Cala Trio therapy is recommended for use at least twice daily to help with the activities listed above. 2.1 Indications for Use Cala Trio is indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in adults with essential tremor (ET). -
Page 7: Cala Trio Therapy Components
2.2 Cala Trio Therapy Components Your Cala Trio Therapy System contains the following: Cala Trio Stimulator • Snaps into the Cala Trio Band • Is worn around your wrist like a wristwatch secured with the Cala Trio Band • Is worn on the wrist of the prescribed hand... -
Page 8: Safety Information
» Covering the mouth • To avoid the risk of electric shock, burns, electrical » On your upper back interference, or death, do not use Cala Trio if you have: » Over the heart area » A pacemaker » On diseased skin »... - Page 9 (arrhythmia). • Do not use Cala Trio near flammable fuel, fumes, • Do not apply Cala Trio over open wounds or rashes, or over or chemicals. swollen, red, infected, or inflamed areas or skin eruptions • Physician approval should be obtained by your prescribing (e.g., phlebitis, thrombophlebitis, varicose veins, etc.).
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Page 10: Cautions
Cala Trio. • Higher stimulation levels may be associated with » Do not use Cala Trio within 3 ½ feet of shortwave or potential for increase in skin irritation, including electrical microwave equipment. stimulation burns of the skin, which may cause focal •... -
Page 11: Adverse Reactions
Cala Trio, only use the accessories recommended by Cala Health with the The following are possible minor/moderate risks or adverse device. reactions that you may experience with the use of Cala Trio: • Use Cala Trio with caution: •... -
Page 12: Setting Up Cala Trio
SETTING UP Cala Trio View instructional videos at my.CalaTrio.com • It is essential that the Cala Trio Stimulator and Band be Setting up Cala Trio is as simple as 1, 2, 3... snapped together correctly. If they become detached, align the half circle cut outs on the back of the stimulator 1. - Page 13 • If there is any excess oil or lotion on your wrist, wash with soap and water and rinse well before wearing Cala Trio. Step 2: Insert your prescribed hand through the band making sure the MAIN button points toward the elbow—not the hand...
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Page 14: Calibrating Cala Trio
Your "Tremor Task" can be found in your prescription checking your prescription information. information or at my.CalaTrio.com. Step 5: Pull the end of the Cala Trio Band to tighten—fasten Note: In order to conserve battery, Cala Trio goes into the Velcro securely and tightly SLEEP mode and fades to black if you are not actively •... - Page 15 You can find your "Tremor Task" in your prescription information or at my.CalaTrio.com Step 2: From Cala Trio, press and hold the MAIN button for 3 seconds to start setup. You will see "press main to Step 4: Press the MAIN button to start the measurement measure 1"...
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Page 16: Setting Therapy Intensity
"Tremor Task", like walking or talking, press the intensity during therapy sessions as needed. DOWN button and then the MAIN button to remeasure. Step 7: Once Measure 1 is saved, Cala Trio will prompt you for Measures 2 and 3 •... - Page 17 To set the intensity: Step 1: Press the MAIN button from "press main to set intensity". Wait 3 seconds before moving to step 2 Step 3: As you continue to press the UP button, you should button feel a tingling sensation in your hand and fingers in the areas highlighted in the images above Step 2: Press the UP button to slowly increase intensity.
- Page 18 3, see the note below to reposition Cala Trio. If needed, to add more water and reposition Cala Trio: Step 5: Press the MAIN button to save the intensity preset » Press the MAIN button and wait for therapy to stop Your Cala Trio therapy is personalized and ready to use! »...
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Page 19: A Therapy Session With Cala Trio
View instructional videos at my.CalaTrio.com Step 3: If prompted, press the MAIN button to do your A therapy session with Cala Trio is easy to start and fit prescribed ”Tremor Task”, or if you would like to skip into your day. - Page 20 » To stop the ramp to your preset, press any button. » Press the UP button to increase intensity. » Press the DOWN button to decrease intensity. Step 5: After collecting your "Tremor Task", Cala Trio will ask if you want to start therapy. Press the MAIN button to button...
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Page 21: How To Stop Cala Trio Therapy
5.2 How to Rate Your Tremor with Cala Trio After 40 minutes, Cala Trio Therapy will automatically stop After collecting your "Tremor Task", Cala Trio will ask you if your when the countdown timer reaches zero minutes and Cala "Tremor Task": Trio displays “therapy complete”. -
Page 22: How To Remove Cala Trio
Step 3: Remove Cala Trio from wrist Note: Leave the stimulator and band attached until you are prompted to replace the band. Cala Trio will display "replace band" in order to maintain effective therapy (see section 6.2 on page 24). -
Page 23: Caring For Cala Trio
, do not remove yellow light base station from base station » Cala Trio displays that it is charging and then fades to red light sleep after a few seconds. replace Cala Trio Band LBL-5117 Rev C AUG 2019... -
Page 24: How To Replace Cala Trio Band
6.2 How to Replace Cala Trio Band Step 4: Place the stimulator attached to the new band in the base station for 15 seconds in order to clear Cala Trio will display “replace band” in order to maintain the "replace band" message effective therapy. -
Page 25: How To Reset Cala Trio
To clean Cala Trio Therapy components, use a disinfecting wipe as often as once per week. If Cala Trio is frozen or otherwise performing in a way that you do not expect, you may perform a reset. Store Cala Trio in the included microfiber bag at room temperature. -
Page 26: Troubleshooting
4.1 on page 12) Step 5: Dampen your wrist If you have any issues using Cala Trio such as unexpected events or changes in performance, please first refer to the Step 6: Tightly secure Cala Trio on your wrist content in this section. - Page 27 Replace Band Replace band as soon as possible. Therapy will be available Cala Trio needs to be charged. Place Cala Trio, with the for ten days after the first appearance of this message. band attached, into the base station. Note the band must See section 6.2 on page 24 for directions on disconnecting...
- Page 28 Error Cala Trio has stopped functioning due to an internal error. Press and hold 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...
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Page 29: Clinical Study Summary
ADLs. the safety and effectiveness of the Cala device to aid in Safety was assessed using adverse event data collected the transient relief of hand tremors in adults with essential during the study. - Page 30 • Many patients in the study were also taking medication for their tremor, and it was difficult to assess the effect of the device compared to medication. Questions about Cala Trio? Visit CalaTrio.com/FAQs...
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Page 31: Technical Specifications
OUTPUT Waveform Biphasic symmetric, rectangular TECHNICAL SPECIFICATIONS Regulated Current or Voltage Constant Current D. C. Component None, zero net current Maximum Output Voltage THER APY SESSION 200 V (+/-20%) Time 40 min per session Maximum Output Current 8 mA at 10 kΩ (+/-20%) Start Therapy Press MAIN button on therapy display... - Page 32 Fully charged battery lasts 5 therapy sessions Transport and Storage Parameters (Cala Trio): Temperature Range -20-45°C (-4-113°F) ELEC TRODES <= 90%, non-condensing Relative Humidity Range Cala Trio Band with multiuse electrodes 700-1060 hPa Type Atmospheric Pressure Range embedded Number of Shelf-life and Storage Electrodes...
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Page 33: Electromagnetic Compatibility Declaration
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 Trio Base Station. Radio Frequency 13.56 MHz (RF) Range 2402 MHz to 2480 MHz (1) This device may not cause harmful interference, and (2) - Page 34 GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS Cala Trio is intended for use in the electromagnetic environment specified below. The customer or the user of Cala Trio should assure that it is used in such an environment. EMISSIONS TESTS COMPLIANCE RF emissions Cala Trio uses RF energy only for its internal function.
- Page 35 At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°, 180°, voltage variations Cala Trio be powered from an uninterruptible power supply or a 180°, 225°, 270° and 315° 225°, 270° and 315° on power supply battery.
- Page 36 FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Cala Trio is used exceeds the applicable RF compliance level above, Cala Trio should be observed to verify normal operation.
- Page 37 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.
- Page 38 Pulse modulation 800 – 960 iDEN 820, 18 Hz CDMA 850, LTE Band 5 GSM 1800; 1720 CDMA 1900; 1700 –1990 GSM 1900; 1845 Pulse DECT; LTE Band 1, 3, 1970 4, 25; UMTS Questions about Cala Trio? Visit CalaTrio.com/FAQs...
- Page 39 IMMUNIT Y TO RF WIRELESS COMMUNICATIONS EQUIPMENT Test Frequency IMMUNITY TEST LEVEL Band MHz) Service Modulation Maximum Power (W) Distance (m) (MHz) (V/m) Bluetooth, WLAN, Pulse 2450 2400 – 2570 802.11 b/g/n, modulation RFID 2450, 217 Hz LTE Band 7 5240 Pulse 5100 –...
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Page 40: Warranty Information
11.0 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 forth in the Product Patient Guide. - Page 41 LBL-5117 Rev C AUG 2019...
- Page 42 Questions about Cala Trio? Visit CalaTrio.com/FAQs...
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