Patient

You can use the Cala kIQ System whenever you like. You may consider doing a therapy session 40 minutes prior to doing any activity for which you want tremor relief. You may do very light activities (like eating or drinking) while the session is ongoing.

The Cala kIQ system can only be used on the hand that it was calibrated for. Because the tremor in your left hand is different from the tremor in your right hand, it is important to consistently use the device calibrated for the hand you are treating. You will not get effective therapy when you use the device on a hand it was not calibrated to treat. Please consult with your physician to determine the hand that will benefit the most from Cala kIQ therapy.

The clinical trials evaluated Cala kIQ therapy in one hand only. It is unknown if simultaneous use on both hands will provide better, worse, or similar benefit. You should use Cala kIQ therapy for one hand at a time.

With a novel technology, first-in-class therapy, Cala Health continues to study Cala kIQ therapy to better understand its use and efficacy and will share insight as we learn.

You will need to use a travel voltage converter to charge the Cala kIQ system. The travel voltage converter must be rated to convert voltage to 110V. Using the power adapter at voltages outside 110V can damage the power adapter and the Cala kIQ Base Station.

You can perform a therapy session, but your therapy data will not be updated on your MyCala.com while you are using the device outside the US. Your therapy session data is stored in the device and will get uploaded to MyCala.com when the Base Station establishes LTE connection. The LTE connection only works in the US.

Do not wear any metallic items on the same wrist as the Cala kIQ system during therapy.

You can find your prescribed tremor task on your Prescription Information Card in the Cala kIQ box. You can find your prescribed band size on the Delivery Ticket in your Cala kIQ box.

Your Cala kIQ account number is the number that identifies you individually to Cala Health. Your Cala kIQ serial number identifies your individual stimulator. These numbers may be useful to know while troubleshooting a problem with Cala Customer Care.

It is recommended that the Cala kIQ system be worn when using therapy.

Leave the stimulator and band attached until you are prompted to replace the band. The Cala kIQ system will display “REPLACE BAND” when band replacement is required in order to maintain effective therapy. The band will last for 90 days from the date of activation.

You can also see an estimate of how many band days you have remaining on the homepage of MyCala.com.

To charge the Cala kIQ system, place the stimulator with the band attached into the base station. The band must be attached to the stimulator in order to charge. Ensure the stimulator is properly connected to the charging points on the base station.

You will know that the system is charging when the device display screen shows the current battery level and the status light on the base station turns green.

It is recommended that you place your stimulator with the band attached into the base station overnight to charge. At a low battery level, it takes 3 – 4 hours to fully charge the Cala kIQ system.

When the battery is fully charged, it should last at least 5 therapy sessions depending on your stimulation intensity. When not using your device for therapy, leave the Cala kIQ system on the base station with the stimulator attached to the band.

When you put on your Cala kIQ system, ensure that the double notches on the band are approximately aligned with the center of the inside of your wrist and that the single notch is in line with your thumb. Pull the end of the Cala kIQ band to tighten and then fasten the band securely and tightly.

• The band should be comfortable but snug enough so it does not slide along or around the wrist

• The electrodes should be flush with the skin

In a therapy session, you should feel a tingling sensation in your wrist, hand and/or fingers but not your pinky. If you aren’t feeling this in any part of the wrist, hand or fingers, consider adjusting the band. If you feel it is only some part of the wrist, hand, and/or fingers, it’s a good start and may be how therapy will work for you. It is important that you feel this tingling in some part of the wrist, hand, and/or fingers.

When you complete your pre- and post-tremor tasks, the Cala kIQ system measures your tremor using an accelerometer. By doing a tremor task before and after your therapy session, you’ll be able to see if your tremor has improved after each session. You can view your tremor improvement score on the Insights page of MyCala.com.

Higher intensity does not necessarily mean better efficacy. It is recommended to stimulate at an intensity that you can feel in your wrist, hand and/or fingers, without causing discomfort or muscle contraction.

There are a few factors that may affect how the sensation feels such as location of the device, the amount of water applied to your wrist before putting the device on, and the stimulation level. Feeling different sensations from day to day is normal and expected. Because there will be some variation in the sensation during each session, you should use the sensations in your thumb, pointer, middle, and ring fingers as a guide for what stimulation level to use for each session. You should set the stimulation intensity at a level that feels perceptible in your hand and fingers but does not cause discomfort or muscle contraction.

Make sure you wet your wrist before starting a therapy session. You can also adjust the stimulation intensity as needed to maintain a comfortable and consistent sensation during sessions.

During your therapy session:

Step 1: To stop the increasing therapy intensity ramping up to your preset, press any button.

Step 2: Press the UP button to increase the intensity.

Step 3: Press the DOWN button to decrease the intensity.

You can also reset your default intensity 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 to select.

Step 2: Press the DOWN button to highlight “RESET”. Then press the MAIN button.

Step 3: Use the UP button to increase the therapy to an appropriate level.

Step 4: Press the MAIN button to stop the therapy. Then press MAIN button again to save the intensity.

You can also consult Customer Care team at 888-699- 1009 or CustomerCare@CalaHealth.com if your therapy is uncomfortable.

If you feel skin irritation, discontinue therapy until the skin irritation resolves. When you resume therapy, make sure you wet your wrist to prevent skin irritation. Additionally, consider reducing the intensity of stimulation.

If your skin irritation persists, consult your prescribing physician and/or consult Customer Care team at 888- 699-1009 or CustomerCare@CalaHealth.com.

Pull the end of the Cala kIQ band to tighten—fasten it securely and tightly. It should be snug enough so it does not slide along or around the wrist. If after tightening the band the electrodes are not flush to the skin, you may need a different band size. Simply reach out to our Customer Care team at 888-699-1009 or CustomerCare@CalaHealth.com for help.

Cleaning the Cala kIQ band can help maintain a good connection between the band and your skin. To clean the Cala kIQ band, use a disinfecting wipe on the inside of the band to wipe the six rectangular, black electrodes. All other Cala kIQ components can also be cleaned by using a disinfecting wipe as often as once per week. When not using therapy, charge the Cala kIQ system overnight on the base station with the stimulator attached to the band.

Please do not use baby wipes or sanitizer wipes to clean as they can damage the device.

Go to www.MyCala.com to login with your username and password. If this is your first time using MyCala.com, look for an email from Cala with your unique secure link. If you cannot find this email, check your spam folder or contact us at 888-699-1009 or at CustomerCare@CalaHealth.com

The MyCala.com portal is a great resource if you are just getting started with therapy. You can view training videos or find answers to common questions about using the Cala kIQ System.

You can also use the MyCala portal to see the results of your therapy over time, such as your tremor improvement statistics.

Finally, you can use the portal to share a report of your results with your healthcare provider.

To download a report to show to your doctor, please follow the steps below:

Step 1: Click ‘Insights’ in the top menu bar

Step 2: Scroll to the bottom of the Insights page

Step 3: Enter the dates for which you would like to run the report

Step 4: Select the device for which you would like to run the report

Step 5: Click ‘View’ to see the report

Step 6: Click ‘Export to PDF’ to download the report

You can either download and print the report and bring it to your doctor at your next visit.

To change the password on MyCala.com, please follow the steps below:

Step 1: Click the avatar with the down arrow in the top right corner of MyCala.com

Step2: Click ‘Account Settings’

Step 3: Scroll to the bottom of this page

Step 4: Enter your current password and your preferred new password (twice)

Step 5: Click ‘Confirm’ in the window that pops up

Step 6: Click ‘Sign Out’

Sign in with your new password

To change your account details (like address and contact information), you will need to contact Customer Care team at 888-699-1009 or CustomerCare@CalaHealth.com.

You can view an estimate of the number of days left on your band on the homepage of MyCala.com.

Cala Therapy delivers electrical stimulation to nerves in the wrist. These nerves project from the wrist to central brain networks that are responsible for generating hand tremor in essential tremor. Stimulation of the nerves in the wrist is thought to disrupt the network activity causing hand tremor and provide temporary and meaningful tremor reduction in your treated hand.

Will Cala Therapy reduce or eliminate my essential tremor symptoms?

Cala Therapy provides temporary relief of hand tremors. In our clinical study, it delivered meaningful tremor improvement in 75% of patients after a single 40-minute therapy session. Cala Therapy users have described the benefits of therapy as allowing greater ease and ability in their everyday activities. On average, patients demonstrated a 49% reduction in tremor amplitude in Activities of Daily Living like eating with a spoon and holding a full cup of water. However, some patients had as large as an 80% reduction. Use of the device is the best way to assess if Cala Therapy is effective for you. (Reference: Pahwa, et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor, Neuromodulation 2019.)

We have limited data from our clinical study to assess this. 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. Cala Health continues to study Cala Trio therapy to better understand its use and efficacy in these situations.

In our clinical study of Cala Trio therapy (see the Patient Guide for details), participants used the device twice per day. To start, we recommend using Cala Trio in this way for two weeks to understand how therapy works for you and fits into your life. It is designed to provide at least five sessions when fully charged. With experience and input from your physician, you may find the frequency of use that works best for you.

As far as its benefit, therapy resulted in temporary short-term tremor reduction. With a novel technology, first-in-class therapy, Cala Health continues to study Cala Trio therapy to better understand its use and efficacy and will share insight as we learn.

What is the battery life of Cala Trio? How long does it take to charge?

When the battery is fully charged, it will last at least 5 sessions depending on your stimulation intensity. At a low battery level, it takes 3-4 hours to fully charge Cala Trio.

In our clinical studies, subjects had short-term tremor reduction that lasted for up to an hour on average after a single 40-minute stimulation session. With a novel technology, first-in-class therapy, Cala Health continues to study Cala Trio therapy to better understand its use and efficacy and will share insight as we learn. (Reference: Data on-file, publication pending)

A stimulation session is 40 minutes. Begin therapy approximately 40 minutes before any activity when you desire temporary reduction of your tremor.

What is/are the best time(s) for me to use Cala Therapy?

Therapy can be administered at any time during your day.

During your 40-minute therapy session, most activities are fine to continue.

Do not use Cala Therapy while sleeping, driving, bathing, operating machinery, and doing any activity in which possible involuntary muscle contractions due to therapy may cause undue risk of injury. Please refer to the labeling for a complete list of warnings, precautions, and contraindications.

Correct placement of the Cala Therapy band is essential to therapy success, so refrain from any activity that would cause the placement of the band to change. If for any reason, you need to remove the band during stimulation, stop the therapy session by pressing and holding the MAIN button until you see “therapy stopped”.

Dampen the entire circumference of your wrist with ample amounts of water before using Cala Trio. If there is any excess oil or lotion on your wrist, wash with soap and water and rinse well before wearing Cala Trio.

The TSA changes procedures from time to time, so you could check on their website. “Remove personal electronic devices larger than a cell phone from your carry-on bag and place them into a bin with nothing placed on or under them for X-ray screening. (E.g. laptops, tablets, e-readers and handheld game consoles.)”

Additionally, some people traveling with medical devices have found it helpful to have

1) a completed TSA notification card and

2) proof of your prescription therapy to present to a TSA officer to help with passenger screening.

You will feel a tingling or pulsing sensation in your fingers. You will be able to decrease the intensity during a therapy session should you feel discomfort.

Cala Trio therapy is only indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in adults with essential tremor. Clinical trials have evaluated it in only this use. With a novel technology, first-in-class therapy, Cala Health continues to study Cala Trio therapy to better understand its use and efficacy and will share insight as we learn.

During set up, Cala Therapy is calibrated by having you perform your prescribed “Tremor Task” three times. This allows the device to characterize your tremor and individualize the stimulation. The accelerometers in the device measure your motion and determine the best pattern to deliver the stimulation.

What do the buttons on Cala Therapy do?

There are three buttons, MAIN, UP, and DOWN that control the main operation of the stimulator. The buttons are used to set up the device, calibrate, and start, stop, or adjust intensity during a therapy session. Please refer to the Patient Guide for full description of the button functionality.

First off, help is right at your fingertips. Available 24 hours/day, we have a number of resources, from the Patient Guide to product videos, on my.calahealth.com. In the Patient Guide, review the Troubleshooting section to see details on how to address specific warning messages.

What support will Cala Health provide to help me with Cala Therapy?

Cala Customer Success provides support, direct to you! We contact you when your device ships to see if you would like assistance with set up and calibration.

Should you need further help, contact Cala Customer Success at 888-699-1009 and Customer Success@CalaTrio.com. We are available from Monday to Friday, 7am-4pm Pacific Time.

Cala Trio is splash proof, but not waterproof; you cannot swim or shower with it on.

Cleaning Cala Trio band can help maintain a good connection between the band and your skin. To clean the band, use a disinfecting wipe on the inside of the band to wipe the three square, black electrodes. All other Cala Trio components can also be cleaned by using a disinfecting wipe as often as once per week.

Yes. The Cala kIQ System is a qualified medical expense under a health savings account (HSA) or flexible spending account (FSA).

Check with your individual plan to confirm your eligibility.

The Medicare Program is currently not covering TAPS therapy. If you are using a Medicare Advantage plan, you may still be covered.

In the interim, there are options available to you:

• You can pay cash for the system
• We also offer a financial assistance program if you qualify
• Veterans get full coverage through the VA system

If you have commercial insurance, you may be covered – Cala Customer Care can help you determine if you are covered and submit claims on your behalf.

Veterans are fully covered through the VA System.

At this time, the traditional Medicare Program is not covering TAPS therapy.

Cala TAPS therapy is a novel technology and we are working hard to expand coverage. We do offer a number of payment options and the Cala kIQ^TM System is a qualified medical expense for health savings accounts (HSA/FSA).

Please call us at (888) 699-1009 to learn about financing options and special pricing for qualified patients.

Some VA facilities are able to purchase the Cala kIQ^TM System through the local prosthetics department. Ask your Veterans Administration Medical Facility to consider Cala Trio therapy for you with these two steps:

• Provide your VA Healthcare Provider with the Doctor Discussion Guide
• Ask the Prosthetics Department to email CustomerCare@CalaHealth.com for Ordering Information

The Cala kIQ™ band uses a proprietary skin interface. The band can be used for months before needing to be replaced. The performance of the band deteriorates with exposure to dry skin, skin oils, and dust. After 90 days, a new band is required in order to maintain effective therapy.

Cala Customer Care will send you a new band when your band has expired. If your band is expiring soon, please call our Customer Care team at (888) 699-1009 or email us at CustomerCare@CalaHealth.com to replace your band.

If you are with the VA System, your band refill may require a consultation with your physician. Please contact your local VA to request a new band. In order to ensure you don’t have a gap in therapy, we recommend contacting your VA ~30 days before your band expires.

There is a 2-year warranty on the device and base station. There is a 45-day warranty on the bands. Patients may connect with Cala Customer Care at 888-699-1009 to assist with product support and replacement as needed.

People using commercial insurance, Medicare Advantage, or cash may participate in a 60-Day Evaluation Program. Veterans Affairs (VA) patients may participate in a 90-Day Evaluation

You can start using the Cala kIQ System to see individualized, on-demand therapy provides tremor relief. If you are not completely satisfied, simply return the device within 60 days and we will refund your purchase price

Cala Therapy has specific bands for left and right wrists. With two (2) complete prescriptions from your physician, we can support you in using therapy on both hands.

Consult with your physician and determine the hand where tremor reduction would help you the most. Cala Therapy provides transient relief of hand tremors in the treated hand.

Can I loan it to a friend?

Cala Therapy is available by prescription for an individual. There are three aspects of the prescription that are unique to you. During calibration, Cala Therapy learns about your tremor and personalizes therapy according to its characteristics. If a friend is interested in Cala Therapy, share your experience, and encourage your friend to talk to their physician about Cala Therapy.

In the clinical trials, subjects used Cala Trio while taking their medication for essential tremor.

It is best to discuss your therapy options with your physician.

The following are possible minor/moderate risks or adverse reactions that you may experience with the use of Cala Therapy:

• 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

Water helps with the connection between your skin and the electrodes in the band. Without water you may experience discomfort or a warning display during therapy.

In the unlikely event that any of the following more significant issues happen, immediately stop using Cala Therapy and contact your physician.

• Signs of significant and persistent skin irritation, sores, 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

For a full list of possible side effects, please refer to the Safety Information.

Talk to your doctor. The device should NOT be used:

• by patients with an implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
• by patients that have suspected or diagnosed epilepsy or other seizure disorder
• by patients who are pregnant
• on swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions

Please refer to the Safety Information for a complete list of warnings and precautions.