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 patientreported 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.
Warnings:
• 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.
Precautions:
• 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.