Indications for Use

Cala kIQ Indications for Use

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.

Contraindications include:

  • Having an implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
  • Having suspected or diagnosed epilepsy or other seizure disorder
  • Pregnancy
  • Having swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions at or in proximity to the treated wrist

Warnings:

  • It is recommended that Cala therapy not be used while simultaneously:
    • Using a percutaneous device, such as a needle or catheter, at the site of stimulation
    • Having implanted metal in the treated wrist
    • Using a non-invasive device that delivers stimulation (other than Cala kIQTM)
    • Using electronic monitoring devices (e.g., cardiac monitors, ECG alarms, continuous glucose monitors (CGMs)), which may not operate properly when Cala kIQ is in use.
    • Patients for whom high-frequency surgical equipment is simultaneously being used, as this may result in electrical burns and/or possible damage to Cala kIQ.
  • Do not use Cala therapy while:
    • 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 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 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 therapy on or near the chest.
    • This may increase the risk of abnormal heart rhythm (arrhythmia), which could cause death.
  • Do not apply 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 kIQ therapy over — or in proximity to — cancerous lesions.
  • To prevent electrical shock, do not immerse Cala kIQ in water.
  • Do not wear Cala kIQ while performing activities where the Cala kIQ device is under water (e.g., swimming or bathing).
  • To prevent an explosion hazard and possible injury, do not use Cala therapy when at a refueling place (e.g., gas station) or near flammable fuel, fumes, or chemicals.
  • Cala therapy provide chronic electrical stimulation, the long-term effects of which are unknown.
  • Patients who do not wet the entire circumference of their wrist before putting on Cala kIQ may experience uncomfortable therapy, skin irritation and/or shock.
  • Cala therapy at an intensity that is too high can cause discomfort in your wrist and/or hand, muscle contraction, or skin irritation, including electrical stimulation burns of the skin, which may cause focal pinpoint edema, erosion, and crusting.
  • Some may experience skin irritation, an allergic reaction, or hypersensitivity to Cala therapy or the band.
  • Avoid removing Cala kIQ from your wrist during therapy.
  • 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.

Cautions:

  • Use Cala therapy only as directed by the Patient Guide or your physician.
  • Store Cala kIQTM 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 to Cala kIQ and/or performance issues:
    • Keep Cala kIQ dry. Cala kIQ can withstand some splashing.
    • Do not use in places with high humidity (e.g., the bathroom).
    • Do not store or transport Cala kIQ 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 kIQ.
    • Do not use or wear Cala kIQ near shortwave. microwave, or medical emitters, such as electrocautery, MRI, CAT scan, electrosurgical unites, or diathermy devices.
  • To prevent damage, performance issues, increased emissions, or decreased immunity of Cala kIQ, only use the accessories recommended by Cala Health with the device.
  • Use Cala therapy with caution:
    • If you tend to bleed following an injury.
    • Over areas of the skin that lack normal sensation.
    • If you have atrial fibrillation.
  • Keep out of the reach of children and pets.
  • Cala kIQ 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.
  • To avoid interfering with diagnostic assessments, do not wear Cala kIQ during x-ray examinations.
  • To prevent 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.

Adverse Reactions:

The following are possible minor risks or adverse reactions that you may experience with the use of 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 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

 

Cala Trio 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 (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.
  • 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 temporary relief of hand tremor is desired (i.e. before activities involving your hands such as meals or writing).

The device  has only been evaluated in subjects diagnosed with Essential Tremor and effectiveness has not been evaluated for tremor associated with other conditions.

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.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Contraindications:

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

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:
    • 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 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 over — or 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 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 .
  • 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 from your wrist during therapy.
  • 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.

Cautions:

  • Use Cala Trio only as directed by the 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.
  • Store Cala Trio in the included microfiber bag to prevent exposure to dust and pets.
  • To prevent damage and/or performance issues to Cala Trio:
    • Keep Cala Trio dry. Cala Trio can withstand some splashing.
    • 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: -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.
    • Do not use Cala Trio within 3 ½ feet of shortwave or microwave equipment.
  • To prevent damage, performance issues, increased 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.
  • To avoid interfering with diagnostic assessments, do not 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 CustomerCare@CalaHealth.com.

Adverse Reactions:

The following are possible minor 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.

  • 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