Studies on the PKG System have demonstrated the following clinical benefits:
- Clinically validated performance measures
- Comprehensive identification and measurement of PD motor symptoms
- Improved decision/treatment planning
- Improved patient dialogue
- Improved quality of life (QoL) and patient outcomes
Performance Characteristics found in PKG System studies:
- 95% sensitivity and 88% specificity comparing BKS with UPDRS III1
- Highly significant correlation (R=0.80, p <0.0001) between DKS and AIMS1
- 85.2% concordance between PTI and PSG in detecting daytime sleep (p < 0.0001). Significant (p = 0.01) association between PTI and high ESS2
- 92.5% sensitivity and 92.9% specificity identifying tremor (PTT ≥0.8%)3
- 72% of time identifies uncontrolled symptoms4
- 75%+ of time influences change in PD treatment plan.5
- 8.5 point improvement in MDS-UPDRS using PKG in treatment plan vs. 4.9 point difference in standard of care arm4
- 59%+ of clinicians reported improvement in patient dialogue & engagement6
Limit of Accuracy
- Limit of accuracy for PKG core scores of bradykinesia (BKS) and dyskinesia (DKS) is 6% and 10%, respectively after 5 days of data recorded by PKG Watch. This limit of accuracy has been established using Standard Error (SE) of measurement in BKS and DKS algorithms reported.7
There are no known contraindications to the use of the PKG.
- If an unexpected event occurs with the PKG System, continue taking your medication as prescribed by your doctor, discontinue using the system and contact PKG Support.
- Do not leave the PKG System near sources of heat and do not use the PKG Watch for extended periods in temperatures greater than 104F (40 C) or less than 41F (5 C).
- Do not use the PKG System if there are signs of physical damage or modification.
- Only use the PKG system components provided by Global Kinetics (GK). Do not modify any parts of the PKG System.
- If you require assistance with setting up or using the PKG System, contact PKG Support.
- Review Instructions for use of any other medical device used on or in the patient or known to be in the patient environment.
- There is no implied drug evaluation by the PKG.
- Keep away from children. Small parts within this product may present a choking hazard if swallowed and cables provided with this product may be a strangulation risk if placed around the neck.
- The PKG Watch should not be worn over broken skin.
- The PKG Watch must not be able to move on the wrist or be secured too tightly.
- If the PKG Watch becomes uncomfortably warm or if you experience a reaction of the skin (e.g. irritation or itchiness) that is in contact with the PKG Watch, remove the PKG Watch immediately and contact your clinic.
- During PKG Watch charging, do not touch the charging connectors and the patient simultaneously.
- Unplug the docking station when not in use.
- Do not attempt to connect the docking station with accessories or cables not provided by Global Kinetics. Use of these accessories or cables could cause safety risks, increased electromagnetic emissions or decresed electromagnetic immunity of this equipment and lead to improper operation.
- Ensure the docking station is positioned such that the power cord is easily removable in case of emergency.
- A USB C port is provided on the side of the docking station. It is reserved for future use. Do not connect any device to the USB C port. Do not use the USB C port to charge other devices such as mobile phones.
- The PKG is to be used and interpreted only by trained clinicians and technicians.
- Do not use the PKG Watch for any purpose other than to record the movement of a patient with a movement disorder.
- The PKG is intended only as an aid to existing clinical methods. It is not intended to be the sole or primary means of clinical assessment.
- Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
- PKGs containing lengthy periods ‘off-wrist’ must be interpreted with caution.
- Always ensure the patient details at the top of the PKG match the patient being treated.
- GK does not recommend configuring medication reminders for patients who are not capable of interacting with the PKG Watch.
- GK does not recommend a PKG for patients who have restricted movement, e.g. confined to bed or with patients who operate heavy machinery for prolonged periods.
- Ensure that your patient is suitable for this recording, i.e. they don’t have already fragile or damaged skin that may be further damaged under the PKG Watch or wrist strap.
- Request the patient remove the PKG Watch immediately and contact you if they experience discomfort (e.g. irritation or itchiness) or a reaction of the skin that is in contact with the PKG Watch or wrist strap.
- If your conditions or symptoms worsen, please contact your clinic.
- Accidental swiping of the PKG Watch may occur which can be safely ignored.
- Accidental Watch swipes have no impact on the performance of the system.
- Please advise patient to contact the clinic if their conditions or symptoms worsen.
Any serious incident* that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
*Serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:
- the death of a patient, user or other person,
- the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
- a serious public health threat.
If the PKG Watch is soiled, clean with warm soapy water.
If the docking station is dirty, wipe it clean with a damp cloth.
Service life of PKG Watch: 6 years from date of manufacture.
Service life of docking station: 10 years from date of manufacture.
Do not dispose of the PKG Watch or docking station. They contain components which are not suitable for disposal via ordinary waste services. Contact PKG Support for details.
EMC Standards Compliance
The PKG Watch and docking station are suitable for use in all domestic environments.
Interference to proper operation of the PKG Watch or docking station may occur if used within 30cm (11.8”) of radio communications equipment.
The PKG Watch and docking station are CISPR 11 Class B equipment & have passed the following tests specified in IEC60601-1-2:
Radiated emissions to CISPR11 Class B.
ESD to IEC 61000-4-2 – 8 kV contact, 15 kV air.
Radiated RF EM fields to IEC 61000-4-3, at 10 V/m from 80 MHz to 2.7 GHz.
Proximity Fields from RF wireless equipment to IEC 61000-4-3-Table 9 in IEC 60601-1-2:2014.
• Radiated emissions to CISPR11 Class B.
• IEC 61000-3-2 harmonic distortion.
• IEC 61000-3-3 voltage fluctuations and flicker
• ESD to IEC 61000-4-2, up to 8 kV contact, 15 kV air.
• Radiated RF EM fields to IEC 61000-4-3, at 10 V/m from 80 MHz to 2.7 GHz.
• Proximity fields from RF wireless equipment to IEC 61000-4-3 Table 9 in IEC 60601-1-2:2020.
Docking station Modem Characteristics
Model: Quectel EC21-V
Contains Transmitter Module FCC ID: XMR201606EC21A
Model: Quectel EG21-G
Contains Transmitter Module FCC ID: XMR201906EG21G
Receive and transmit frequency bands used:
• FDD-LTE: 1,3,5,7,8,20
• WCDMA: 1,5,8
• GSM: 900/1800
Preferred frequency band: N/A
Bandwidth of the receiving section of the equipment: 1.4MHz to 20MHz
Type of modulation used: LTE-FDD, WCDMA & GSM
Effective radiated power:
• LTE-FDD Max: 23dBm +/- 2dB LTE-FDD Min: <-39dBm
• WCDMA Max: 24dBm +1/-3dB WCDMA Min: <-49dBm
• GSM Max: 33dBm+/- 2dB GSM Min: 5dBm+/-5dB
Electrical specifications – PKG Watch
Power source: internally powered.
Input power: 5V DC, 120 mAmax.
Mode of operation: continuous.
Degree of protection against electric shock: Type BF applied part.
Degree of protection against ingress of water and dust: IP57 (protected from the effects of dust and suitable for immersion at 1 meter for 30 minutes).
Electrical specifications – Docking station
Power adapter part number: FRIWO FOX12-FM
Power source: mains powered.
Input power: 5V DC, 2.2Amax.
Mode of operation: continuous.
Degree of protection against ingress of water and dust: IP21 (protected against solid objects over 12.5mm and vertically falling drops of water or condensation)
Temperature range: 5˚C (41F) to 40˚C (104F)
Humidity range: 15% to 90%
Pressure: 700hPa to 1060hPa
Keep dry and keep away from direct sunlight.
Transport and Storage conditions
Storage temperature range: -25˚C (-13F) to 70˚C (158F)
Storage humidity range: 15% to 90%
Keep dry and keep away from direct sunlight.
System Software Compatibility
- At the end of the monitoring period, the PKG Watch is required to be connected to a docking station in order to upload the data to GK Cloud Platform for processing.
- Docking station is required to be connected to local internet network to be able to upload the data from the PKG Watch to the GK Cloud Platform.
- The PKG Portal supports the latest stable version of Google Chrome and Microsoft Edge on a desktop computer or laptop. Earlier versions of these browsers, other unsupported browsers or devices may be used at the risk of text and graphics not displaying as intended.
- Unique credentials are maintained for each user. Please do not share account credentials or passwords and ensure the secure storage of this information.
- Passwords must meet minimum complexity criteria.
- A user can request change of password, in which case a unique link is sent to user’s email address.
- If a user is inactive for a period of time the application will automatically log the user out.
- Griffiths RI, Kotschet K, Arfon S, Xu ZM, Johnson W, Drago J, Evans A,Kempster P, Raghav S, Horne MK. Automated assessment of bradykinesia and dyskinesia in Parkinson’s disease. J Parkinsons Dis. 2012;2(1):47-55.
- Kotschet K, Johnson W, McGregor S, Kettlewell J, Kyoong A, O’Driscoll D.M, Turton A.R, Griffiths R.I. Horne M, 2014. Daytime sleep in Parkinson’s disease measured by episodes of immobility. Feb 2014. 1353-8020/ 2014 Elsevier Ltd.
- Braybrook M, O’Connor S, Churchward P, Perera T, Farzanehfar P, Horne M. An Ambulatory Tremor Score for Parkinson’s Disease. J Parkinsons Dis. 2016 Oct 19;6(4):723-731.
- Woodrow H, Horne M, Fernando C, Kotschet K, Treat to Target Study Group (2020) A blinded, controlled trial of objective measurement in Parkinson’s disease. npj Parkinson’s Disease 6:35;, https://doi.org/10.1038/s41531-020-00136-9.
- Nahab FB, Abu-Hussain H, Moreno L. (2019) Evaluation of Clinical Utility of the Personal KinetiGraph in the Management of Parkinson’s Disease. Advances in Parkinson’s Disease, 8, 42-61. https://doi.org/10.4236/apd.2019.83005
- Joshi R, Bronstein JM, Alcazar J, Yang D, Joshi M, Hermanowicz N. An Observational Study of PKG Movement Recording System Use in Routine Clinical Care of Patients with Parkinson’s Disease. Movement Disorders Front. Neurol., 01 October 2019 | https://doi.org/10.3389/fneur.2019.01027
- Horne, Malcolm, Katya Kotschet, and Sarah McGregor. “The clinical validation of objective measurement of movement in Parkinson’s disease.” CNS. Vol. 1. 2016.
LBL-77 PKG System Product Information V1 Nov 22