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1 2 | User manual | Users Manual | 2.48 MiB | March 09 2019 / April 09 2019 |
PATIENT GUIDE Caution: Federal law restricts this device to sale by or on the order of a physician LBL-5117 Rev C AUG 2019 Manufactured by Cala Health, Inc. 875 Mahler Road, Suite 168 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, CTB105, CTB106 TABLE OF CONTENTS 1.0 List of Symbols .....................................................................4 2.0 Introducing Cala Trio ...........................................................6 2.1 Indications for Use ................................................................. 6 2.2 Cala Trio Therapy Components ......................................... 7 3.0 Safety Information ............................................................. 8 3.1 Warnings ................................................................................... 8 3.2 Cautions ................................................................................ 10 3.3 Adverse Reactions ................................................................ 11 4.0 Setting Up Cala Trio .......................................................... 12 4.1 Positioning and Fastening Cala Trio .................................12 4.2 Calibrating Cala Trio .............................................................14 4.3 Setting Therapy Intensity ....................................................16 5.0 A Therapy Session with Cala Trio ....................................19 5.1 How to Stop Cala Trio Therapy .......................................21 5.2 How to Rate Your Tremor with Cala Trio .......................21 5.3 How to Remove Cala Trio ................................................... 22 6.0 Caring for Cala Trio .......................................................... 23 6.1 How to Charge Cala Trio .................................................... 23 6.2 How to Replace Cala Trio Band ......................................... 24 6.3 How to Change Stimulation Intensity Preset ................ 24 6.4 How to Reset Cala Trio ........................................................ 25 6.5 How to Clean and Store Cala Trio .................................... 25 7.0 Troubleshooting ................................................................ 26 8.0 Clinical Study Summary .................................................. 29 9.0 Technical Specifications.................................................... 31 10.0 Electromagnetic Compatibility Declaration .................. 33 11.0 Warranty Information .......................................................40 LBL-5117 Rev C AUG 2019 1.0 LIST OF SYMBOLS Caution Refer to instructions for use. Sold by prescription only. Caution: Federal law restricts this device to sale by or on the order of a physician. Type BF Applied Part(s) Manufacturer Contains electronic equipment Properly dispose in accordance with local regulations. Date of manufacture Complies with United States Product Safety Standards. Use by date 4 Questions about Cala Trio? Visit CalaTrio.com/FAQs IP22 Protected against intrusion 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. 101kPa Cala Trio is rated for these atmospheric pressure limits. For more information on environmental parameters, refer to the Technical Specifications in this User Guide. 70kPa 40C 104F 5C 41F Cala Trio is rated for these temperature limits. For more information on environmental parameters, refer to the Technical Specifications in this User Guide. 90%
0%
Cala Trio is rated for these humidity limits. For more information on environmental parameters, refer to the Technical Specifications in this User Guide. Serial number Catalogue number Batch code Class II Equipment 5 LBL-5117 Rev C AUG 2019 Cala Trio therapy is delivered during 40-minute stimulation sessions, which can be started and stopped on demand. Cala Trio therapy should be applied when transient relief 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. 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 tremors in the treated hand following stimulation in adults with essential tremor (ET). Cala Trio is a non-invasive, wrist-worn device for adults with essential tremor. Meaningful relief is usually observed after use. Electrodes embedded in a cloth band (Cala Trio Band), deliver therapy to nerves in the wrist. 6 Questions about Cala Trio? Visit CalaTrio.com/FAQs 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 Cala Trio Band Contains electrodes Delivers therapy to nerves in your wrist Designed for either right- or left-handed use Needs to be replaced to maintain effective therapy delivery Cala Trio Base Station AC-powered base station in which Cala Trio sits for recharging Base Station Cala Trio Stimulator Band 7 LBL-5117 Rev C AUG 2019 3.0 SAFETY INFORMATION This section lists general Warnings and Cautions related to using Cala Trio. 3.1 Warnings To avoid the risk of electric shock, burns, electrical interference, or death, do not use Cala Trio if you have:
A pacemaker An implanted defibrillator Other implanted electronic devices, or implanted metal in the wrist Do not use Cala Trio while:
8 Sleeping Driving Bathing Operating machinery Doing any activity in which possible involuntary muscle contractions due to therapy may cause undue risk of injury. Do not use Cala Trio:
Near the head Directly on the eyes Covering the mouth On your upper back Over the heart area On diseased skin Do not use Cala Trio on the neck. Doing so can cause severe muscle spasm, resulting in closure of the airway, difficulty with breathing, or Questions about Cala Trio? Visit CalaTrio.com/FAQs adverse effects on heart rhythm. Do not use Cala Trio on the chest. Introduction of electric current into the chest may cause rhythm disturbances to the heart, which could cause death. Do not apply Cala Trio near the chest. This may increase the risk of abnormal heart rhythm
(arrhythmia). Do not apply Cala Trio over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions
(e.g., phlebitis, thrombophlebitis, varicose veins, etc.). Do not apply Cala Trio overor in proximity to cancerous lesions. To prevent electrical shock, do not immerse Cala Trio in water. Do not wear Cala Trio while performing activities where Cala Trio is under water (e.g., swimming or bathing). Do not use Cala Trio simultaneously with High-frequency surgical equipment, as this may result in electrical burns and/or possible damage to Cala Trio Electronic- monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when Cala Trio is in use To prevent an explosion hazard and possible injury, stop Cala Trio therapy when at a refueling place
(e.g., gas station). Do not use Cala Trio near flammable fuel, fumes, or chemicals. Physician approval should be obtained by your prescribing physician before using Cala Trio if you have any implanted devices at the site of stimulation. Cala Trio provides chronic electrical stimulation, the long-
term effects of which are unknown. To prevent uncomfortable therapy, skin irritation and/or shock, the user should wet their wrist before donning Cala Trio. Therapy at an intensity that is too high can cause 9 LBL-5117 Rev C AUG 2019 discomfort in your wrist and/or hand, muscle contraction, or skin irritation. Store Cala Trio in the included microfiber bag to prevent exposure to dust and pests. Some may experience skin irritation, an allergic reaction, To prevent damage and/or performance issues to Cala Trio:
or hypersensitivity to the therapy or the band. Keep Cala Trio dry. Cala Trio can withstand Avoid removing Cala Trio from your wrist during therapy. some splashing. To charge Cala Trio, use only the Cala Trio Base Station. The cord on the charger may present a choking hazard. Keep away from children. 3.2 Cautions Use Cala Trio only as directed by this Patient Guide or your physician. Do not use Cala Trio if you have suspected or diagnosed epilepsy or other seizure disorder. Do not use Cala Trio if you are pregnant. Higher stimulation levels may be associated with potential for increase in skin irritation, including electrical stimulation burns of the skin, which may cause focal pinpoint edema, erosion and crusting. Do not use in places with high humidity
(e.g., the bathroom). Do not store or transport Cala Trio or its accessories in temperatures that exceed the recommended storage temperature range: -20C to 45C (-4F to 113F). Do not operate in temperatures that exceed the recommended operation temperature range of 5C to 40C (41F to 104F). Temperature extremes can damage the device and accessories. Do not tamper with, modify, or attempt to perform maintenance or servicing on Cala Trio. Do not use Cala Trio within 3 feet of shortwave or microwave equipment. To prevent damage, performance issues, increased 10 Questions about Cala Trio? Visit CalaTrio.com/FAQs emissions, or decreased immunity of Cala Trio, only use the accessories recommended by Cala Health with the device. Use Cala Trio with caution:
If you tend to bleed following an injury. Over areas of the skin that lack normal sensation. Keep out of the reach of children and pets. Cala Trio is single-patient use by the individual for whom it has been prescribed. It should not be worn by anyone else, or on any other part of your body. 3.3 Adverse Reactions The following are possible minor/moderate risks or adverse reactions that you may experience with the use of Cala Trio:
Discomfort with stimulation (e.g. stinging, sensation of weakness, etc.) Allergic reaction to electrodes or other materials Skin irritation, including electrical stimulation burns, redness and/or itching In the unlikely event that any of the following more significant issues happen, immediately stop using Cala Trio and contact your physician. To avoid interfering with diagnostic assessments, do not Signs of significant and persistent skin irritation, sores, wear Cala Trio during x-ray examinations. To prevent Cala Trio band damage, do not pinch, pull, or twist the Band with too much force. Should any technical problem occur that is not covered in the Patient Guide, please contact Cala Health at 888-699-1009 or CustomerSuccess@CalaTrio.com electrical stimulation burns, or lesions at the site of stimulation Significant and persistent increase in muscle tightness or stiffness A feeling of chest pressure during stimulation Swelling of your arm, wrist, or hand 11 LBL-5117 Rev C AUG 2019 4.0 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 2. Calibrating 3. Setting therapy intensity 4.1 Positioning and Fastening Cala Trio Positioning and fastening Cala Trio on your wrist correctly is important to therapy success. Check your delivery ticket to verify the size and handedness of the band. 12 It is essential that the Cala Trio Stimulator and Band be snapped together correctly. If they become detached, align the half circle cut outs on the back of the stimulator and band as you attach them together. Step 1: Dampen entire wrist circumference with ample amounts of water before positioning Cala Trio Questions about Cala Trio? Visit CalaTrio.com/FAQs This ensures a good connection between the electrodes and wrist. Never submerge Cala Trio in water. If there is any excess oil or lotion on your wrist, wash with soap and water and rinse well before wearing Cala Trio. Note: Correct placement of the Cala Trio Band electrodes is essential to therapy success. Step 2: Insert your prescribed hand through the band making sure the MAIN button points toward the elbownot the hand Step 3: Center the stimulator on the back of your wristas close to the hand as possible without hindering wrist movement Step 4: Ensure that the blue mark on the band is aligned with the center of the inside of your wrist and that the white mark is in line with your thumb. Reposition if necessary 13 LBL-5117 Rev C AUG 2019 4.2 Calibrating Cala Trio During stimulator setup, Cala Trio learns about your tremor and personalizes therapy according to its characteristics. Calibration happens over the course of three measurements taken while you perform the "Tremor Task" prescribed by your physician. Before calibrating, determine your "Tremor Task" by Your "Tremor Task" can be found in your prescription information or at my.CalaTrio.com. checking your prescription information. Note: In order to conserve battery, Cala Trio goes into SLEEP mode and fades to black if you are not actively pressing any buttons. Press any button to wake up Cala Trio. UP button DOWN button MAIN button Step 1: Press the MAIN button to wake up the stimulator. You should see Cala Trio displayed Step 5: Pull the end of the Cala Trio Band to tightenfasten the Velcro securely and tightly Should be snug enough so it does not slide along or around the wrist. The electrodes should be flush to the skin. 14 Questions about Cala Trio? Visit CalaTrio.com/FAQs Step 3: Get in position to do your "Tremor Task" (see left) 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 measure 1"
Step 4: Press the MAIN button to start the measurement OR Step 5: Perform your Tremor Task until all dots are blue
(~20 seconds). Cala Trio will vibrate when the Tremor Task is complete Outstretched postural hold Wing-beating postural hold 15 LBL-5117 Rev C AUG 2019 Step 6: If you correctly performed your "Tremor Task" for the full measurement, press the MAIN button to save the measurement Note: If you were moving in a way unrelated to your tremor during the "Tremor Task", like walking or talking, press the 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 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. 16 4.3 Setting Stimulation Intensity for Therapy After calibrating Cala Trio to your tremor, you will set the stimulation intensity preset. Cala Trio automatically ramps to the intensity preset during all subsequent therapies. It is important to find the maximum level of therapy that you can comfortably tolerate for 40 minutes. Note: You will always be able to increase or decrease the intensity during therapy sessions as needed. Reminder: Ensure you have dampened the entire circumference of your wrist with ample amounts of water before setting stimulation intensity. Questions about Cala Trio? Visit CalaTrio.com/FAQs To set the intensity:
Step 1: Press the MAIN button from "press main to set intensity". Wait 3 seconds before moving to step 2 UP button Step 3: As you continue to press the UP button, you should 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. You may not feel the sensation right away 17 LBL-5117 Rev C AUG 2019 Step 4: Once you find the highest intensity level that you can comfortably tolerate for a 40-minute therapy session, press the MAIN button to stop stimulation Note: Choose an intensity below a level that causes discomfort or muscle contraction. Step 5: Press the MAIN button to save the intensity preset Your Cala Trio therapy is personalized and ready to use!
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 your wrist sufficiently before fastening Cala Trio. See the note below to add more water. You should not feel the tingling sensation in your pinky. Additionally, if you do not feel the tingling sensation in the fingers highlighted in step 3, see the note below to reposition Cala Trio. If needed, to add more water and reposition Cala Trio:
Press the MAIN button and wait for therapy to stop Press the DOWN button to highlight 'reset intensity'
and the MAIN button to select Add water to your wrist (see section 4.1, page 12) or adjust the placement of the band (see section 4.1, step 3, page 13) Repeat steps 1-3 when you are ready to set your intensity again (see section 4.3, pages 16-18) 18 Questions about Cala Trio? Visit CalaTrio.com/FAQs 5.0 A THERAPY SESSION WITH Cala Trio View instructional videos at my.CalaTrio.com A therapy session with Cala Trio is easy to start and fit into your day. periodically before and after therapy sessions. Cala Trio will prompt you in a similar way as described in section 4.2, steps 3-5, on page 15. Step 3: If prompted, press the MAIN button to do your prescribed Tremor Task, or if you would like to skip and are given the option, press the DOWN button and then MAIN to skip until next session UP button DOWN button MAIN button Step 4: If prompted, do your "Tremor Task" (i.e., outstretched postural hold or wing-beating postural hold) Step 1: To start a therapy session, from the time display, press the MAIN button. You will now see "start session"
To complete your "Tremor Task"
You can find your "Tremor Task" in your prescription information or at my.CalaTrio.com. Step 2: Press the MAIN button again to start a session Get in position to do your "Tremor Task". Note: "Tremor Task" measurements will be prompted Press the MAIN button to start the measurement. 19 LBL-5117 Rev C AUG 2019 Perform "Tremor Task" until all dots are blue (~20 seconds) is then 40 minutes of stimulation. Note: The "tingling" sensation of stimulation will naturally vary from day to day. You can adjust the intensity as needed to maintain a consistent sensation during therapy and across sessions. 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 start therapy UP button DOWN button MAIN button Step 6: The 40-minute timer will begin countdown Note: Once therapy starts, it automatically ramps to your intensity preset while displaying "starting therapy." Therapy 20 Questions about Cala Trio? Visit CalaTrio.com/FAQs 5.1 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 when the countdown timer reaches zero minutes and Cala Trio displays therapy complete. After collecting your "Tremor Task", Cala Trio will ask you if your
"Tremor Task":
Step 1: To stop therapy early, press and hold the MAIN button until you see "therapy stopped"
When therapy stops, Cala Trio vibrates to indicate therapy has stopped or is complete. If you were prompted to do your "Tremor Task" before therapy, it will prompt you to perform your "Tremor Task"
again after therapy (repeat section 5.0, steps 3 and 4 on pages 19-20). 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 to highlight the rating you want 2 1 LBL-5117 Rev C AUG 2019 Step 3: Press MAIN button to save your rating 5.3 How to Remove Cala Trio AVOID REMOVING Cala Trio DURING THERAPY Between sessions, you can remove Cala Trio by:
You have successfully completed a therapy session with Cala Trio!
Step 1: Make sure therapy has stopped. If you are in the middle of a session, press and hold the MAIN button until you see "therapy stopped (see section 5.1 on page 21) Step 2: Unfasten the band to release the Velcro connection 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). 22 Questions about Cala Trio? Visit CalaTrio.com/FAQs 6.0 CARING FOR Cala Trio View instructional videos at my.CalaTrio.com status light 6.1 How to Charge Cala Trio Charge Cala Trio Overnight With band attached to the stimulator Note: The band must be attached to the stimulator in order to charge. Step 1: Place the stimulator with the band attached into the base station Cala Trio displays that it is charging and then fades to sleep after a few seconds. The base station will also communicate its status via a light. The table below shows the status light options:
white light ready to charge green light charging yellow light device updating , do not remove from base station red light replace Cala Trio Band 23 LBL-5117 Rev C AUG 2019 6.2 How to Replace Cala Trio Band Cala Trio will display replace band in order to maintain effective therapy. Step 4: Place the stimulator attached to the new band in the base station for 15 seconds in order to clear the "replace band" message Step 1: Check that the size and the handedness of the band 6.3 How to Change Stimulation Intensity Preset matches your prescription information found at my.CalaTrio.com Change the preset if you would prefer a different stimulation intensity for therapy. Step 1: From the time display, press the UP or DOWN buttons until you see intensity setting. Press the MAIN button 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 band and stimulator as you snap them together 24 Questions about Cala Trio? Visit CalaTrio.com/FAQs Step 1: Press and hold the MAIN and UP buttons at the same time for a few seconds until Cala Trio displays powering down Step 2: Press the DOWN button to highlight 'reset.' Then press the MAIN button UP button MAIN button Step 3: Use the UP button to increase the therapy to an appropriate level. See steps 2-3 in section 4.3 on page 17 for more detail Step 4: Press the MAIN button to stop the therapy. Then press the MAIN button again to save the intensity. You will now see the clock 6.4 How to Reset Cala Trio If Cala Trio is frozen or otherwise performing in a way that you do not expect, you may perform a reset. Step 2: Release the buttons and Cala Trio will automatically restart displaying Cala Trio 6.5 How to Clean and Store Cala Trio To clean Cala Trio Therapy components, use a disinfecting wipe as often as once per week. Store Cala Trio in the included microfiber bag at room temperature. 25 LBL-5117 Rev C AUG 2019 7.0 TROUBLESHOOTING View instructional videos at my.CalaTrio.com If you have any issues using Cala Trio such as unexpected events or changes in performance, please first refer to the content in this section. If issues continue, please contact Cala Health at 888-699-1009 or CustomerSuccess@CalaTrio.com Step 2: If prompted, complete the post therapy "Tremor Task" and rating Step 3: Remove Cala Trio from your wrist Step 4: Ensure the stimulator is securely and correctly snapped into the band (half circles should be aligned as shown in section 4.1 on page 12) Step 5: Dampen your wrist Step 6: Tightly secure Cala Trio on your wrist Step 7: Restart therapy. If warning persists, stop using Cala Trio and contact Cala Health at 888-699-1009 or CustomerSuccess@CalaTrio.com Band Not Connected Therapy has stopped. To resolve the issue:
Powering Down Step 1: Press MAIN button to exit the warning Appears when the stimulator resets. 26 Questions about Cala Trio? Visit CalaTrio.com/FAQs Charge Device Replace Band Cala Trio needs to be charged. Place Cala Trio, with the band attached, into the base station. Note the band must be attached in order for the device to charge. Replace band as soon as possible. Therapy will be available for ten days after the first appearance of this message. See section 6.2 on page 24 for directions on disconnecting and connecting the stimulator and band. Adjust Band on Wrist Replace Band Follow the same steps listed on page 26 for Band Not Connected warning. Replace band as soon as possible. Therapy will not be available until a new band is attached. See section 6.2 on page 24 for directions on disconnecting and connecting the stimulator and band. 27 LBL-5117 Rev C AUG 2019 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 Temperature Exceeded Cala Trio has stopped working because the temperature is too high inside the stimulator. Remove it from your wrist and allow the stimulator to cool down. 28 Questions about Cala Trio? Visit CalaTrio.com/FAQs 8.0 CLINICAL STUDY SUMMARY A multi-center, prospective, randomized, double-blinded, sham-stimulation controlled study was conducted to assess the safety and effectiveness of the Cala device to aid in the transient relief of hand tremors in adults with essential tremor. The study enrolled 93 patients across four US sites. Each patient was seen for a single three-hour appointment at a study site. Patients were randomized one-to-one to either the investigational stimulation (treatment group) or sham stimulation (sham group). The stimulation amplitude for the treatment group was based on each patients stimulation threshold. The sham group received 0-amplitude stimulation. The study site personnel and investigator were not blinded and knew the patients therapy allocation. However, the patient and the raters assessing the effectiveness were blinded. The patients tremor severity was assessed before, during, and immediately after the 40-minute stimulation session using various metrics, such as spiral drawings and activities of daily living (ADLs). Patients had an improvement in tremor severity, as well as an improvement in ADLs compared to baseline. However, there was a lack of statistical significance between treatment and sham groups for both tremor severity and ADLs. Safety was assessed using adverse event data collected during the study. Three percent (3/93) of enrolled patients experienced four non-serious adverse events (one patient reported two adverse events). The four 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). 29 LBL-5117 Rev C AUG 2019 The limitations of the study were that:
The device was only evaluated in patients diagnosed with essential tremor, and the effectiveness of the device has not been evaluated for tremor associated with other conditions;
Effectiveness was only evaluated within one clinic visit immediately after a 40-minute stimulation session, and it is unknown if repeated treatment will provide better, worse or similar benefit;
The active device provided stimulation that could be felt by the patient, while the sham device was inactive; it is therefore possible that some patients could have correctly identified the treatment group they were in, which could have biased study results; and 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. 30 Questions about Cala Trio? Visit CalaTrio.com/FAQs 9.0 TECHNICAL SPECIFICATIONS THERAPY SESSION Time 40 min per session Start Therapy Press MAIN button on therapy display Stop Therapy Press and hold MAIN button Manual Intensity Increase/Decrease 0.5 mA per step CONDITIONS THAT WILL TERMINATE OUTPUT Time 40 min per session OUTPUT Waveform Biphasic symmetric, rectangular Regulated Current or Voltage Constant Current D. C. Component None, zero net current Maximum Output Voltage
(+/-20%) 200 V Maximum Output Current
(+/-20%) 8 mA at 10 k Pulse Duration (+/- 20%) 300 sec (Fixed) Pulse Repetition Frequency
(+/-20%) 150 Hz (Fixed) Pulse Pattern Continuous, bursts tuned to tremor frequency between 4-12 Hz 3 1 LBL-5117 Rev C AUG 2019 POWER Battery Type Power Source Permanent rechargable battery, not serviceable or replaceable AC 50/60 Hz Rated Voltage: 100-240V Max Current: 0.5 A Duration Fully charged battery lasts 5 therapy sessions ENVIRONMENTAL Operating Parameters:
Temperature Range Relative Humidity Range Atmospheric Pressure Range Transport and Storage Parameters
(Cala Trio):
5-40C (41-104F) 15-90%
700-1060 hPa ELECTRODES Type Cala Trio Band with multiuse electrodes embedded Temperature Range Relative Humidity Range
-20-45C (-4-113F)
<= 90%, non-condensing Atmospheric Pressure Range 700-1060 hPa Number of Electrodes 3 Dimensions 22mm x 22mm MEASUREMENT ACCURACY Shelf-life and Storage Parameters (Electrodes):
Temperature Range 20-27C (68-81F) Relative Humidity Range
<= 90%
Atmospheric Pressure Range 700-1060 hPa Frequency
+/- 20% in the 4-12 Hz range Expected Service Life of Stimulator and Base Station: 3 years 32 Questions about Cala Trio? Visit CalaTrio.com/FAQs 10.0 ELECTROMAGNETIC COMPATIBILITY DECLARATION Cala Trio Stimulator claims compliance for electromagnetic compatibility in conjunction with Cala Trio Base Station.
(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Do not tamper with, modify, or attempt to perform maintenance or servicing on Cala Trio. GENERAL RADIO COMPLIANCE ITEM SPECIFICATION Stimulator Bluetooth Module FCC ID: 2AA9B05 Radio Frequency
(RF) Range 2402 MHz to 2480 MHz Base Station FCC ID: 2AT2D-BASE0017 Radio Frequency
(RF) Range 13.56 MHz 2402 MHz to 2480 MHz LTE Module FCC ID: XPY2AGQN4NNN Radio Frequency
(RF) Range Device operates within approved frequencies overlapping with the following cellular bands: LTE 2,1900 PCS UP | LTE 25,1900+ UP | LTE 35,TD PCS Lower DOWN | UMTS CH 2 UP | UMTS CH 25 UP |
UMTS CH 35 DOWN |
33 LBL-5117 Rev C AUG 2019 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 CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage Fluctuations/
Flicker emissions Group 1 Class B Class A Complies Cala Trio uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Cala Trio is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY 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. IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 34 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment. Questions about Cala Trio? Visit CalaTrio.com/FAQs GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Surge IEC 61000-4-5
(50/60 Hz) magnetic field IEC 61000-4-8 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Voltage Dips 30%
reduction, 25/30 periods At 0 Voltage Dips 30%
reduction, 25/30 periods At 0 Voltage Dips > 95%
reduction, 0.5 period At 0, 45, 90, 135, 180, 225, 270 and 315 Voltage Dips > 95%
reduction, 0.5 period At 0, 45, 90, 135, 180, 225, 270 and 315 Voltage Dips > 95%
reduction, 1 period At 0 Voltage Dips > 95%
reduction, 1 period At 0 Voltage Interruptions >
95% reduction, 250/300 periods Voltage Interruptions >
95% reduction, 250/300 periods Mains power quality should be that of a typical commercial or hospital environment. If the user of Cala Trio requires continued operation during power mains interruptions, it is recommended that Cala Trio be powered from an uninterruptible power supply or a battery. 35 LBL-5117 Rev C AUG 2019 GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz (6 Vrms in ISM and amateur radio Bands within 150kHz 80MHz) 3 Vrms Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz 10 V/m Portable and mobile RF communications equipment should be used no closer to any part of Cala Trio, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2P d = 1.2P 80 MHz to 800 MHz d = 2.3P 800 MHz to 2.7 GHz where P is the maximum 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 determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and 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. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating Cala Trio. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 36 Questions about Cala Trio? Visit CalaTrio.com/FAQs 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. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter M 150 kHz to 80 MHz d = 1.2 P 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2.7 GHz d = 2.3 P 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum 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 power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 37 LBL-5117 Rev C AUG 2019 IMMUNITY TO RF WIRELESS COMMUNICATIONS EQUIPMENT Test Frequency
(MHz) Band a)MHz) Service a) Modulation b) Maximum Power
(W) Distance
(m) IMMUNITY TEST LEVEL
(V/m) 380 390 TETRA 400 430 470 GMRS 460, FRS 460 704 787 LTE Band 13, 17 800 960 1700 1990 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4, 25; UMTS Pulse modulation b) 18 Hz FM c) 5 kHz deviation 1 kHz sine Pulse modulation b) 217 Hz Pulse modulation b) 18 Hz Pulse 1.8 2 0.2 2 2 0.3 0.3 0.3 0.3 0.3 27 28 9 28 28 385 450 710 745 780 810 870 930 1720 1845 1970 38 Questions about Cala Trio? Visit CalaTrio.com/FAQs IMMUNITY TO RF WIRELESS COMMUNICATIONS EQUIPMENT Test Frequency
(MHz) Band a)MHz) Service a) Modulation b) Maximum Power (W) Distance (m) IMMUNITY TEST LEVEL
(V/m) 2450 2400 2570 5240 5500 5785 5100 5800 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 WLAN 802.11 a/n Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz 2 0.2 0.3 0.3 28 9 a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. 39 LBL-5117 Rev C AUG 2019 11.0 WARRANTY INFORMATION Cala Health, Inc. (Cala) warrants, to the original purchaser only, that 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 forth in the Product Patient Guide. You can find conditions and details for this Limited Warranty at CalaTrio.com/Warranty 40 Questions about Cala Trio? Visit CalaTrio.com/FAQs 41 LBL-5117 Rev C AUG 2019 42 Questions about Cala Trio? Visit CalaTrio.com/FAQs
1 2 | Label art work & location | ID Label/Location Info | 262.60 KiB | March 09 2019 / April 09 2019 |
D C B A 8 7 6 5 4 101 31 2. 3. 4. 5. 6. FCC ID: 2AT2D-BASE0017 Also contains FCC ID: XPY2AGQN4NNN 88 3 REV. 1 2 3 2 REVISIONS DESCRIPTION INITIAL RELEASE UPDATE ARTWORK UPDATE ARTWORK 1 ECO ECO000177 ECO000215 ECO000287 NOTES (UNLESS OTHERWISE SPECIFIED):
1. MATERIAL: PN1602 COMMERCIAL BASE STATION MIDDLE (FOR REFERENCE: CYCOLOY HC1204HF) APPEARANCE SURFACES TO BE FREE OF COSMETIC DEFECTS. SERIAL NUMBER: PARTS ARE TO BE MARKED WITH A UNIQUE ALPHA-
NUMERIC CODE OF THE FORMAT B#####, WHERE ##### IS A FIVE-DIGIT NUMBER ASSIGNED SEQUENTIALLY. CERTIFICATE OF CONFORMANCE: MATERIAL MUST BE ACCOMPANIED BY THE MANUFACTURER'S CERTIFICATE OF CONFORMANCE, SIGNED BY AN AUTHORIZED REPRESENTATIVE, AND MUST INCLUDE THE FOLLOWING:
1. 2. 3. 4. CONTAINER PACKAGING: BAG PARTS WITH CALA PART NUMBER, REVISION, VENDOR LOT NUMBER, MANUFACTURING DATE AND QUANTITY CLEARLY MARKED ON THE BAG. (FOR REFERENCE: PARTS MUST BE SHIPPED IN A CONTAINER DESIGNED TO PREVENT DAMAGE AND CONTAMINATION.) CALA RECEIVING INSPECTION:
1. 2. 3. 4. VERIFY PACKAGING. INSPECT TO AQL 4.0 INSPECT FOR ALL CIRCLE DIMENSIONS ON THE DRAWING. VERIFY ARTWORK CONTENT APPEARS AS DESIGNATED. CALA PART NUMBER AND REVISION VENDOR LOT NUMBER OR EQUIVALENT P.O. NUMBER QUANTITY D C B 8 7 6 5 4 3 2 1 UNLESS OTHERWISE SPECIFIED: DIMENSIONS ARE IN MILLIMETERS, IN ACCORDANCE WITH ANSI Y14.5M-2004 TOLERANCES ARE:
.2
.10
.05 FILLET RADII BREAK CORNERS ANGLES
.25 - .50
.10 - .25 0.5
.X
.XX
.XXX MACHINE SURFACE 63
.10 TIR
.10
.050 / IN
.050 / IN TITLE DRAWN CAD FILE N. GOLDMAN PN1731 (3) Commerical Base Station Middle Marked 07/10/19 NOTICE - CONFIDENTIAL INFORMATION THIS DRAWING AND THE SUBJECT MATTER CONTAINED HEREIN ARE THE PROPERTY OF CALA, INC AND MAY NOT BE COPIED, REPRODUCED OR DISCLOSED TO OTHERS WITHOUT THE EXPRESS WRITTEN PERMISSION OF A DULY AUTHORIZED AGENT OF THE COMPANY. THIS DRAWING IS SUBJECT TO RECALL BY CALA, INC AT ANY TIME. COMMERCIAL BASE SIZE STATION MIDDLE MARKED B PN1731 DWG. NO. SCALE 1.5:1 DO NOT SCALE DRAWING REV 3 SHEET 1 of 1 875 Mahler Rd #168, Burlingame, CA 94010 A
1 2 | Letter of Agency | Cover Letter(s) | 141.84 KiB | March 09 2019 / April 09 2019 |
WWW.CALAHEALTH.COM 875 MAHLER RD, SUITE 168 BURLINGAME, CA 94010 July 8, 2019 Intertek Testing Services NA Ltd. 70 Codman Hill Road Boxborough, MA 01719 Subject:
Limited Agency Agreement Cala Health, Inc. FCC ID: To Be Determined To Whom It May Concern:
We, Cala Health, Inc., hereby authorized Intertek to act as our Agent for the purpose of preparing application for a new FCC ID number under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is July 8, 2019. The Limited Agency Agreement expires on July 7, 2020, unless sooner terminated or extended by written notice to Intertek Testing Services and the Federal Communications Commission. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. The applicant is not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 U.S.C. 862, and no party to the application is subject to a denial of federal benefits pursuant to that section. If you have any questions or comments, please do not hesitate to contact me. Sincerely, Scott A. Wilson, PhD Vice President, Regulatory Affairs and Quality Assurance
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-09-04 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
2 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2019-09-04
|
||||
1 2 | Applicant's complete, legal business name |
Cala Health
|
||||
1 2 | FCC Registration Number (FRN) |
0028654697
|
||||
1 2 | Physical Address |
875 Mahler Rd Ste 168
|
||||
1 2 |
875 Mahler Rd
|
|||||
1 2 |
Burlingame, CA
|
|||||
1 2 |
United States
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
t******@intertek.com
|
||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
1 2 |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
|||||
app s | FCC ID | |||||
1 2 | Grantee Code |
2AT2D
|
||||
1 2 | Equipment Product Code |
BASE0017
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
M****** A**** S********
|
||||
1 2 | Title |
Head of Hardware
|
||||
1 2 | Telephone Number |
65026********
|
||||
1 2 | Fax Number |
na********
|
||||
1 2 |
m******@calahealth.com
|
|||||
app s | Technical Contact | |||||
1 2 | Firm Name |
Cala Health
|
||||
1 2 | Name |
M****** A******** S****
|
||||
1 2 | Physical Address |
Ste 168
|
||||
1 2 |
Burlingame, California 94010
|
|||||
1 2 |
Burlingame, 94010
|
|||||
1 2 |
United States
|
|||||
1 2 | Telephone Number |
65026********
|
||||
1 2 |
m******@calahealth.com
|
|||||
app s | Non Technical Contact | |||||
1 2 | Firm Name |
Cala Health
|
||||
1 2 | Name |
S****** A**** W******
|
||||
1 2 | Physical Address |
Ste 168
|
||||
1 2 |
Burlingame, California 94010
|
|||||
1 2 |
Burlingame, 94010
|
|||||
1 2 |
United States
|
|||||
1 2 | Telephone Number |
92587********
|
||||
1 2 |
925-8********
|
|||||
1 2 |
s******@calahealth.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | DXX - Part 15 Low Power Communication Device Transmitter | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Cala Trio Base Station | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Power Output listed is conducted. This transmitter may not be co-located or operated in conjunction with any other antenna or transmitter except according to FCC multi-transmitter guidelines. End- users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
IntertekTesting Services NA Inc.
|
||||
1 2 | Name |
C****** P******
|
||||
1 2 | Telephone Number |
650-4********
|
||||
1 2 | Fax Number |
650 4********
|
||||
1 2 |
c******@intertek.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 2402.00000000 | 2480.00000000 | 0.0006300 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC