Cala kIQ™ System

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.