Indications for Use
Cala Trio Indication for Use: Cala Trio is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
Cala Trio has only been evaluated in subjects diagnosed with Essential tremor and effectiveness has not been evaluated for tremor associated with other conditions.
Cala kIQ Indications for Use: Cala kIQ is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor. Cala kIQ is indicated to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson’s disease.
In a clinical study, many participants were also taking medications for their tremor and it was difficult to assess the effect of the device compared to medication. Please refer to the safety information for a complete listing of warnings and cautions.
Caution: Federal law restricts this device to sale by or on the order of a physician.
This device should NOT be used:
- by people with an implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
- by people that have suspected or diagnosed epilepsy or other seizure disorder
- by people who are pregnant
- on swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions
- To avoid the risk of electric shock, burns, electrical interference, or death, do not use Cala Trio or Cala kIQ therapy if you have:
- A pacemaker
- An implanted defibrillator
- Other implanted electronic devices, or implanted metal in the wrist
- Do not use Cala Trio or Cala kIQ therapy while:
- 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 or Cala kIQ therapy:
- 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 or Cala kIQ therapy on the neck.
- Doing so can cause severe muscle spasm, resulting in closure of the airway, difficulty with breathing, or adverse effects on heart rhythm.
- Do not use Cala Trio or Cala kIQ therapy 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 or Cala kIQ therapy near the chest.
- This may increase the risk of abnormal heart rhythm (arrhythmia).
- Do not apply Cala Trio or Cala kIQ therapy 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 or Cala kIQ therapy over — or in proximity to — cancerous lesions.
- To prevent electrical shock, do not immerse Cala Trio or the Cala kIQ device in water.
- Do not wear Cala Trio or the Cala kIQ device while performing activities where Cala Trio or the Cala kIQ device is under water (e.g., swimming or bathing).
- Do not use Cala Trio or the Cala kIQ device simultaneously with:
- High-frequency surgical equipment, as this may result in electrical burns and/or possible damage to Cala Trio or the Cala kIQ device.
- Electronic- monitoring equipment (e.g., cardiac monitors, ECG alarms), which may not operate properly when Cala Trio or the Cala kIQ device is in use.
- To prevent an explosion hazard and possible injury, stop Cala Trio or Cala kIQ therapy when at a refueling place (e.g., gas station).
- Do not use Cala Trio or the Cala kIQ device near flammable fuel, fumes, or chemicals.
- Physician approval should be obtained by your prescribing physician before using Cala Trio or Cala kIQ therapy if you have any implanted devices at the site of stimulation.
- Cala Trio and Cala kIQ therapy provide 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 the or Cala kIQ device.
- Therapy at an intensity that is too high can cause discomfort in your wrist and/or hand, muscle contraction, or skin irritation.
- Some may experience skin irritation, an allergic reaction, or hypersensitivity to the therapy or the band.
- Avoid removing Cala Trio or the Cala kIQ device from your wrist during therapy.
- To charge Cala Trio, use only the Cala Trio Base Station.
- To charge the Cala kIQ device, use only the Cala kIQ Base Station with the power cord, BW100PA.
- The cord on the charger may present a choking hazard. Keep away from children.
- Use Cala Trio or Cala kIQ therapy only as directed by the Patient Guide or your physician.
- Do not use Cala Trio or Cala kIQ therapy if you have suspected or diagnosed epilepsy or other seizure disorder.
- Do not use Cala Trio or Cala kIQ therapy 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.
- Store Cala Trio in the included microrfiber bag to prevent exposure to dust and pets.
- Store the Cala kIQ device to prevent exposure to dust and pests. It is recommended to store the device in the original packaging when not in use or being charged.
- To prevent damage and/or performance issues to Cala Trio or the Cala kIQ device:
- Keep Cala Trio or theCala kIQ device dry. Cala Trio or the Cala kIQ device can withstand some splashing.
- Do not use in places with high humidity (e.g., the bathroom).
- Do not store or transport Cala Trio or the Cala kIQ device or its accessories in temperatures that exceed the recommended storage temperature range: -20°C to 45°C (-4°F to 113°F).
- Do not operate in temperatures that exceed the recommended operation temperature range of 5°C to 40°C (41°F to 104°F). Temperature extremes can damage the device and accessories.
- Do not tamper with, modify, or attempt to perform maintenance or servicing on Cala Trio or the Cala kIQ device.
- Do not use Cala Trio or the Cala kIQ device within 3 ½ feet of shortwave or microwave equipment.
- To prevent damage, performance issues, increased emissions, or decreased immunity of Cala Trio or the Cala kIQ device, only use the accessories recommended by Cala Health with the device.
- Use Cala Trio or Cala kIQ therapy 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 and Cala kIQ therapy are 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.
- To avoid interfering with diagnostic assessments, do not wear Cala Trio or Cala kIQ therapy during x-ray examinations.
- To prevent Cala Trio or Cala kIQ 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 CustomerCare@CalaHealth.com.
The following are possible minor risks or adverse reactions that you may experience with the use of Cala Trio or Cala kIQ 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
In the unlikely event that any of the following more significant issues happen, immediately stop using Cala Trio or Cala kIQ therapy and contact your physician.
- Signs of significant persistent skin irritation, sores, electrical stimulation burns, or lesions at the site of the stimulation
- Significant and persistent increase in muscle tightness or stiffness
- A feeling of chest pressure during stimulation
- Swelling of your arm, wrist, or hand
Skin Care Guidelines
The device works by electrically stimulating nerves through the skin. It is important to inspect your skin where it contacts the electrodes to minimize risk of irritation. To promote good electrode connection and healthy skin, try some of these skin care guidelines:
- If there is any excess oil or lotion on your wrist, wash with soap and water and rinse well before wearing Cala Trio or the Cala kIQ system
- Always check your skin for irritation, redness, or rash when putting on and taking off Cala Trio or the Cala kIQ system
MKG-1613 Rev B