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
- Users must wear the Apple Watch on their most affected arm at all times.
- Charging the Apple Watch is recommended during user’s 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.
- Users 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 user or the caregiver can not do it alone.
- Users should respond to medication reminders in a timely and correct manner.
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 user should wear the Apple Watch on the most affected arm.
- Dyskinetic symptom tracking should be considered only for users with chorea on the affected arm, either self-reported or diagnosed by a healthcare provider.
- 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 user’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 adequate recording durations, Parky will not be able to generate symptom reports. The reports are generated utilizing the following methodology:
- Intervals of fifteen minutes, covering the entire duration of the recording, are organized according to the user’s local time.
- Intervals with less than 50% of the required data are excluded.
- The weekly and monthly reports display the mean tremor and dyskinesia symptom durations from all days with data.
- In the weekly and monthly reports, only the intervals with data collected from at least five days or representing over 20% of the total period are displayed.
- Medication schedules are subject to the correctness of data entered by the user. If the user 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 user’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 users.
- The step information relies on the user’s consistent use of both Apple Watch and iPhone. Parky cannot collect step data if the user is not utilizing either of these devices.
- Specific to Foggy: Haptic cueing sessions are restricted to a maximum duration of 10 minutes. To maintain uninterrupted cueing sessions, users should avoid sending the app to the background, minimizing view changes, and refraining from app termination, as these actions will halt the sessions.
- If users would like to stop using Parky, they can cancel their prescription. Upon prescription cancellation, the user is considered as a dropout, and the prescription is immediately switched to an invalid state. Users 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 the user’s Parky reports. A new prescription will be required for the user to restart using Parky.
- If users would like to stop using Parky permanently, they can permanently delete their account. Upon account deletion, the user is considered as a dropout, and the health and personal data of the user will permanently be removed. Both the user and healthcare provider will loose access to the user’s Parky reports.
Safety
- The use of Parky and Apple Watch does not affect users 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).
General Warnings and Precautions
- The Parky App is to be used and interpreted only by trained healthcare providers 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.
Support & Troubleshooting
- In case you need support, go to the “Support & Troubleshooting” section in the “Profile” tab, click “Send Support Request,” describe your issue briefly, and send us your request.
- You can reach out to us about a variety of issues, including but not limited to:
- Questions about using the Parky app or hardware
- Issues with recording symptoms
- Issues with payments
- You can also contact support@parkynow.com in case of any issues or requests
Data Security
- Parky collects motion data only when the user wears an Apple Watch.
- Besides motion data, Parky does not collect heart rate, voice, mobile & phone activities, screen, or app usage data.
- User data can only be shared with the prescribing healthcare provider for whom the user or caregiver provided consent and can only be shared with one healthcare provider at a time.
- User data, including personally identifiable information, is stored on HIPAA compliant servers using Advanced Encryption Standard (AES256). User data is never shared with a third party except for authorized healthcare provider.
- It is advised to install a mobile security software to further ensure the security of the device.
Adverse Events
- If the user’s symptom reports do not match healthcare provider expectations, immediately stop using Parky during clinical practice.
- In case of any suspected miscalculations, technical problems, and other events, contact support@parkynow.com
