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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 are competent enough to 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.

Hardware Use Instructions

• 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).
• Patients are advised to wear the Apple Watch at all times except during night sleep. Parky cannot monitor symptoms anytime the Apple Watch is not worn, which would cause data gaps.

General App Use Instructions

• Apple Watch should be worn on the most affected arm at all times.
• Patients are advised to wear the Apple Watch at all times except during night sleep. Without sufficient recording times, Parky will be unable to generate symptom reports. Please see “Limitations” for more information.
• Parky App should not be deleted on the iPhone or Apple Watch.
• Patients should enter the correct medication schedule to ensure the reliability of medication compliance outputs. Medication scheduling is recommended to be set up in a clinical environment if the patient is unable.
• Patients should respond to medication reminders in a timely and correct manner.


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: https://help.apple.com/pdf/watch/8/en_US/apple- watch-user-guide-watchos8.pdf.
• User manual and guides 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).


• The Parky App is Rx 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.


• Please contact  in case of any issues or requests stated below and not limited to:
• Low recording time indicators on the reports even though the device had been used correctly by the patient
• Reports with no data
• Activation code issues
• Parky App or hardware use support


Parky operates under the following constraints:
◦ The patient should wear 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 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 does not operate on unsupported devices.
Parky only operates with MM4PD software version 1.0.0, developed by Apple. Any version change on MM4PD is automatically detected, and Parky operation will be suspended until a new validation is conducted.
• Parky is not advised to be used on other Parkinsonian syndromes other than idiopathic Parkinson’s Disease, such as progressive supranuclear palsy (PSP), multiple system atrophy (MSA), and corticobasal degeneration (CBD).
• 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:
15-minute periods comprising a 24-hour day are organized according to the local time of the patient.
◦ Windows with less than 50% of available data are discarded.
Tremor percentages are averaged over all days with data. Dyskinesia likely presence is displayed as the median.
Only windows with data from at least 5 days or more than 20% of the total period are shown for the weekly and monthly reports.
• The symptom reports should not be assessed solely for disease management without evaluating non-motor symptoms, patient-reported insights, and in-clinic visits. 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 entered data by the patient. If the patient is not competent enough, it is strongly advised to provide support in-clinic settings.
• Medication compliance information is subject to patient adherence for responding to med reminder notifications. Non-responded notifications or misuse can generate incorrect numbers for medication compliance. To lower this risk, it is strongly advised that the health care providers clearly underline the importance of reminder responses to the patients.
• Steps information is subject to patient adherence to Apple Watch and iPhone use. Parky cannot collect step information when the patient is not using any of these devices.
• If the patient decides to stop using Parky, they may delete their clinician information from the app. In that case, the patient is considered a dropout from treatment, and the activation code is immediately switched to an invalid state. Patients will not be able to view or share their symptom reports with an invalid activation code; thus, the clinician will not be able to receive any symptom reports. A dropout patient notification will be sent to the prescriber healthcare provider immediately. A new prescription and activation code will be required to restart using Parky.

Data Security

Parky only collects motion data as long as the patient wears 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 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 clinicians.
• It is advised to install 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

• Parky is a supportive tool for assessing Parkinson’s Disease treatment efficacy and disease course. 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 watch on the arm with symptom onset.
• Patients or caregivers must be advised to enter their med schedule; if the patient cannot carry this out themselves, it is recommended to support the patient in-clinic settings by healthcare providers or caregivers.


• In case of Parky App failure, patients should take medication as prescribed.
• There is no implied drug evaluation by the Parky App.
• Patients should not self-evaluate their disease progress solely with Parky app data.


• The Parky App is 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 does not recommend using the Parky App with patients who are not capable of interacting with the Parky App iOS app or WatchOS app.