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Indications, Safety and Cautions

Indications for Use

• The Parky App is intended to quantify kinematics of movement disorder symptoms including tremor and dyskinesia, in adults (45 years of age or older) with mild to moderate Parkinson’s disease.
• Parky is intended only for clinically diagnosed idiopathic Parkinson’s Disease patients who can use an Apple Watch and an iPhone. The benefits of Parky are enhanced when used by tremor and dyskinesia symptom dominant patients. It is not advised to use Parky to assess clinically diagnosed Parkinsonian syndromes such as MSA, PSP, and Lewy.

General Instructions for Hardware and App Use

  • Patients must wear the Apple Watch on their most affected arm at all times.
  • Charging the Apple Watch is recommended during patients’ inactive hours (Preferably during night sleep).
  • Parky cannot monitor symptoms when the Apple Watch is not worn which would cause data gaps.
  • Without sufficient recording times, Parky will be unable to generate symptom reports. Please see the “Limitations” section for more information.
  • Parky App should not be deleted either on the iPhone or on Apple Watch.
  • Patients should enter the correct medication schedule to ensure the reliability of medication adherence outputs. Medication scheduling is recommended to be set up in a clinical environment if the patient or the caregiver can not do it alone.
  • Patients should respond to medication reminders in a timely and correct manner.

Safety

  • The use of Parky and Apple Watch does not affect patients with Deep Brain Stimulation (DBS) implants.
  • Apple Watch is water-resistant but not waterproof. It can be worn and used during exercise (exposure to sweat is OK), in the rain and while washing hands.
  • Please refer to the original manufacturer document regarding the user manual and guides for Apple Watch hardware user manual:  https://help.apple.com/pdf/watch/8/en_US/apple- watch-user- guide  Guide for Apple Watch: https://support.apple.com/en-us/HT204665
  • Apple Watch conforms to the following EMC and Electrical Standards: Electrical safety was assessed according to IEC 62368-1 (2014), “Audio/video, information and communication technology equipment – Part 1: Safety requirements.” Apple Watch conforms to EU standards EN 301 489-1 (V2.2.20), EN 301 489-3 (V2.1.1), EN 301 489-17 (V3.2.0), and EN 301 489-52 (V1.1.0).

Cautions

• The Parky App is Prescription only. Parky App must be on the order of a licensed healthcare provider according to the federal law restrictions.
• Parky App should only be used by the patient for whom the prescription was written. For medical questions, please contact your healthcare provider.
• If you are experiencing a medical emergency, please dial 911. Parky App is not intended to be used as a stand-alone therapeutic and is not a substitute for the medication. Patients with conditions such as photosensitive epilepsy, color blindness, or physical constraints that prevent them from using a mobile device should speak with their doctor before using the Parky App.
• For the safe operation of your mobile device, kindly adhere to all manufacturer’s instructions. For instance, this can entail using the correct volume controls, charging the battery properly, avoiding operating the gadget if it is damaged, and disposing of the device properly. For any queries or issues relating to your device, get in touch with the maker of your mobile device.

Support & Troubleshooting

  • Go to the “Support & Troubleshooting” section on the “Profile” tab and click the “Send Support Request” button, provide a brief explanation of the issue you are facing and send a support request
  • Potential issues or requests can be delivered are stated below and not limited to:
      • Parky App or hardware use related queries
      • Payment issues
      • Symptom recording issues even though the device had been used correctly by the user.
  • You can also contact in case of any issues or requests

Limitations

  • Parky operates under the following constraints:
    • Parky only operates on Apple Watch and iPhone using the MM4PD algorithm developed by Apple. 
    • Parky does not operate on unsupported devices.
    • Parky is advised to be used for idiopathic Parkinson’s Disease, and not to be used on other Parkinsonian syndromes such as progressive supranuclear palsy (PSP), multiple system atrophy (MSA), Lewy, and corticobasal degeneration (CBD).
    • The patient should wear the Apple Watch on the most affected arm.
    • Dyskinetic symptom tracking should be considered only for patients with chorea on the affected arm, either self-reported or diagnosed by a clinician.
    • Parky explicitly tracks resting tremor; it does not track action tremor or postural tremor, and it may not track finger tremor.
    • Parky does not explicitly track dystonia or bradykinesia.
    • The results may include false positives and false negatives.The patient’s activity, watch band fit, and concomitant conditions (such as restless legs syndrome and non-Parkinsonian tremor) can affect the quality of the results.
    • Parky only explicitly measures symptoms from the wrist while wearing the Apple Watch. However, Apple Watch may sense symptoms transmitted through the body from other affected body parts, possibly resulting in misleading or false metrics.
  • Parky cannot collect data when Apple Watch is turned off and cannot transmit data when iPhone is turned off. 
  • Without sufficient recording times, Parky will be unable to generate symptom reports. The reports are generated using the following approach:
    • Fifteen-minute intervals, spanning the entire recording duration,  are organized based on the local time of the patient.
    • Intervals with less than 50% of the required data are excluded.
    • The weekly and monthly reports provide averaged tremor percentages across all days with data, while the likely presence of dyskinesia is presented as the median.
    • In the weekly and monthly reports, only intervals with data collected from at least 5 days or representing more than 20% of the total period are displayed.
  • The symptom reports should not be assessed solely for disease management. Data provided by Parky should be considered together with the patient’s clinical history, motor and non-motor complications, and other clinical findings as well as recording times.
  • Medication schedules are subject to the correctness of data entered by the patient. If the patient has difficulties in using the app, it is strongly advised to provide support in-clinic settings.
  • The accuracy of medication adherence information relies on the patient’s prompt and accurate response to medication reminder notifications. Failure to respond or providing inaccurate interactions may lead to incorrect medication adherence outputs. To mitigate this risk, healthcare providers are strongly encouraged to emphasize the crucial importance of accurate reminder responses to patients.
  • The step information relies on the patient’s consistent use of both Apple Watch and iPhone. Parky cannot collect step data if the patient is not utilizing either of these devices.
  • If patients would like to stop using Parky, they can cancel their prescription. Upon prescription cancellation, the patient is considered a dropout from treatment, and the activation code is immediately switched to an invalid state. Patients maintain access to the app to review their existing information and previous reports.However, post-cancellation, the app will not generate new reports. Additionally, the prescribing healthcare provider loses access to Parky reports. A new prescription and activation code will be required to restart using Parky.

Data Security

  • Parky collects motion data only when the patient wears an Apple Watch.
  • Besides motion data, Parky does not collect heart rate, voice, mobile & phone activities, screen, or app usage data.
  • Patient data can only be shared with the prescribing clinician for whom the patient or caregiver provided consent and can only be shared with one clinician at a time.
  • Patient data, including personally identifiable information, is stored on HIPAA compliant servers using Advanced Encryption Standard (AES256). Patient data is never shared with a third party except for authorized clinician.
  • It is advised to install a mobile security software to further ensure the security of the device.

Adverse Events

• If the patient’s symptom reports do not match clinician expectations, immediately stop using Parky during clinical practice.
• In case of any suspected miscalculations, technical problems, or other events, contact   or click Adverse Event / MDR

General Warnings and Precautions

  • The Parky App is to be used and interpreted only by trained clinicians or technicians.
  • Do not use the Parky App for any purpose other than to record the movement of a patient with a movement disorder.
  • The Parky App is intended only as an aid to existing clinical methods. It is not intended to be the sole or primary means of clinical assessment. 
  • h2o therapeutics does not recommend employing the Parky App for patients who lack the capability to interact with either the Parky App on iOS or WatchOS.
  • Non-motor findings, patient insights, and in-clinical visits should always be involved in decision-making.
  • It is strongly advised to compare Parky results with clinical findings and patient reported insights.
  • At initial use to verify data flow consistency, patient results are recommended to be observed closely for 3 to 5 days per patient.This period would also allow the detection of any technical issues.
  • Patients should be advised to wear the Apple Watch on the most affected arm.
  • Patients or caregivers are encouraged to input the medication schedule. If the patient is unable to do so independently or with the help of their caregivers, healthcare providers are recommended to offer assistance in clinic settings.
  • Patients should not self-evaluate their disease progress solely with Parky app data.
  • In case of Parky App failure, patients should take medication as prescribed.
  • There is no implied drug evaluation by the Parky App.