® pdnfbnitor ENGLISH INSTRUCTIONS FOR USE Ve 「sion: 0.
FCC Warning This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any inte rference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
Contents Intended Use 6 Contraindications 6 Warnings 7 Precautions Package Contents 10 PDMonito卢System 14 Setup Instructions 15 7.1 Unpacking the PDMonito 「 ® System 15 7.2 Configure SmartBox to the PD Neu 「otechnology Cloud 16 7.2.1 Registe 「 via Ethe 「net Cable 16 7.2.2 Registe 「 via Wi-Fi 16 7.3 ID 8.1 4 SmartBox Light lndicato 「 17 Monitoring Device Usage 19 Placing the Manito 「ing Devices on the Body fo 「 a NewReco 「ding 20 8.
11.3.1 SmartBox Internet Connectivity 34 11.16 T 「aininq 42 11.3.2 SmartBox Account Synchronization 34 11.17 Device 43 11.18 Wi-Fi Setup 44 11.4 Pai 「ing 35 11.5 WelcomePage 36 ＠ 11.6 Login a.P 「ivacyPolicy b. Regist 「ation c. Login 36 36 37 37 Mobile Application T 「oubleshooting 45 ＠ System Requirements for You 「 Smartphone 45 11.7 Main Menu 37 '-1' Technical Specifications 46 11.8 Medication 38 '"7 Warranty and Service 47 11.9 Nut 「ition 38 ＠ Disposal 47 11.
Intended Use PDMonitor ® is a non-invasive continuous monitoring system for patients with Pa 「kinson's Disease (PD). It is intended to trace, 「eco 「d, process and sto 「e a variety of moto 「 symptoms f 「equently occurring in PD through the continuous use of a set of wearable Monito 「ing Devices.
Warnings CD Do not use the system on an open wound. CD The environment where the device is used should be 「easonably 「 f ee from vibration. dust. co 斤osive o「 combustible matter and avoid ext「emes of tempe「atu「e and humidity. CD Should the「e be an alle「gic reaction o「 skin irritation. 「emove the Monitoring Device. Then. take pictures of the affected a「eas and keep detailed notes on the symptoms. CD All adverse events or side effects should be reported immediately to PD Neurotechnology Ltd.
Precautions CD CD CD CD CD excessive heat o 「 fire may result in inc 「eased risk of device damage. explosion. chemical burn or fire. Do not crush. punctu 代， 0 「 burn as doing so can 「esult in fire, explosion o 「 the 「elease of toxic gases. Do not use the device if it appears to be leaking. damaged, discolored. misshapen. o 「 in any way irregula 「. If there are any signs of material degradation on the Monitoring Devices o 「 the SmartBox.
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Photo q 。 Description Qty. Hook and loop strap 2 (small) 1 (large) Power supply unit (GSM25EOS-P1J) 1 Ethernet cable 1 pdmbnitor· INS丁RUC1 IONS FOR USE Instructions for Use 凶心...心..
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PDMonitor ® System Monitoring Device light Indicator SmartBox The SmartBox (Figure 1) is the PDMonito卢unit where the Monitoring Devices should be placed to upload thei「data to the PD Neurotechnology storage service (Cloud). The SmartBox also charges the PDMonitor ® Monitoring Devices. Monitoring Device micro USB port Figure 1. PDMonitor ® SmartBox Figure 2. PDMonitor ® Monitoring Device Accessories The wristband.
Setup Instructions The SmartBox requi 「es an Internet connection either via an Ethernet cable or an available W币network to function prope「ly. To 「eceive the full benefit of using the PDMonito卢system. the SmartBox should be registered with an account. which in turn will be paired with a t 「eating physician who will evaluate the data produced by the device. Fo「 details on how to create an account and pai 「 with a 甘eating physician. consult the PDMonitor ® Instructions for Use (section 11 .4). 5.
7.2.2 Register via Wi-Fi 7. The Monitoring Devices start charging. When charging, each Monitoring Device is flashing orange. 7.2 Configure SmartBox to the PD Neurotechnology Cloud The SmartBox must be connected to the PD Neurotechnology sto「age service (Cloud) to be properly configured eithe「 via Ethernet cable or an available Wi-Fi netwo「k. This requires an Internet connection. 7.2.1 1. 2. 3. Connect the SmartBox to the power outlet 2.
7.3 SmartBox Light Indicator In this section. the light indicator functionalities of the PDMonito「 @ Power status light indicator SmartBox are described at Figure 7. 8. 9 and 10.
Setup Inst 「uctions Alarm status light Indicator Internet connection light indicator ＃ 1 2 ． Light ind i ca tor color Bl ue OFF Sta te F un ction Consta nt Internet conne ction is a va ila ble Consta nt No Internet conne ction a va ila ble ＃ 1 ． Light ind i ca tor color Red Sta te F un ction The PDMonitor ® is NOT f un ctioning pro a nd y o u m ust c� e c the PDMonitor ® mobile a ppmli ca tion fo r mo 「e fo rma tion a nd a lerts.
Monitoring Device Usage PDMonito产system records the symptoms of Parkinson's Disease only while Monitoring Devices a 「e mounted on p 「edefined body locations. PDMonito卢shall only be used when all Monito 「ing Devices a「e cha「ged and the light status indicato「s (Figure 7) are green. This indicates that PDMonito产system is 「eady fo「 a new reco「ding.
Manito 「ing Device Usage 8.1 Placing the Monitoring Devices on the Body for a New Recording The five (5) PDMonito卢Monitoring Devices must be placed on specific body locations fo 「 PDMonitor ® system to function properly. Those specific body locations a 「e depicted in Figure 11. The following section describes in detail how to prope 「ly mount the Monitoring Devices.
Wrist position Monitoring Devices Figure 13.
Monitoring Device Usage Leg position Monitoring Devices Place the twoMonitoring Devices using the appropriate strapf 「ames and straps on the left and right leg as shown in Figu「e14 · Undock theMonito「ing Devices from the Sma 「tBox · Secu 「e the Monitoring Devices to the strapframe as shown in Figure 15 by sliding the Monitoring Devices inside the frame and then pushing the strapframe sides until a characteristic "clicking·sound or feeling on the hand occurs • · ） • Place the Monitoring Devices in th
Leg position Manito 「ing Devices 3 2 5 4 Figure 15.
Monitoring Device Usage Waist position Monitoring Device • • • · You should wea 「 the last (fifth) Monitoring Device fo 「 the waist position using the provided clipframe to the appropriate body position (Figure 16). Anothe 「 way to wear it.
Waist position Monitoring Device 2 5 4 Figure 17.
Monitoring Device Usage 8.2 Placing the Monitoring Devices on the SmartBox after the Recording Period Afte 「 the 「ecording time recommended by you 「甘eating physician. take off the Manito「ing Devices and put them back in the 2 '� PDMonito「 ® SmartBox. When you place the Monitoring Devices in the Sma 「tBox. the cor 「esponding light status indicato 「 should start flashing orange. While flashing, Monitoring Devices are uploading their data and should not be removed from the SmartBox.
Wrist position Monitorin9 Devices • Remove each Monitoring Device from the wristbands, as shown in Figure 18 • Place the Monitoring Devices into the slots of the SmartBox, as shown in Figure 19 3 6 5 4 Figure 19.
Monitoring Device Usage Leg position Monitoring Devices • Remove each Monito 「ing Device的m the strapframes, as shown in Figure 20 Place the Monitoring Devices into the slots of the Srna 「tBox. as shown in Figu 「e 21 2 3 5 6 4 Figure 20.
Leg position Monitoring Devices Place the Monito 「ing Devices into the slots of the SmartBox 3 Figure 21.
Monitoring Device Usage Waist position Monitoring Device • Remove the Monitoring Device from the clipframe. as shown in Figure22 , Place the Monitoring Device into the last slot of the SmartBox. as shown in Figu 「e23 3 5 6 30 t t 2 Figure 22. Instructions on removing PDMonitor .
Waist position Manito门ng Device Place the Monitoring Device into the slot of the SmartBox Upon placing the Monitoring Devices into the SmartBox the cor「esponding light status indicator should start flashing orange. While flashing orange. the devices should not be removed from the SmartBox. 2 figure 23.
System Maintenance Monitoring Device Usage 8.3 Monitoring Device Light Indicator Functionality The functionality of the Monitoring Device light indicato 「 is shown in Figu 「e 24. Monitor Device light indicator # I 1 I 2 I ． ． Light indicator color Blue Blue I State Function Enabled for 3 seconds when device quickly turned towards patient's face Monitoring Device is working properly Flashing every 1 second Monitoring Device battery is low. Charging is needed Figure 24.
9.3 Cleaning the SmartBox The SmartBox can be cleaned by using a soft damp towel. Household cleansers should be avoided. After a full charge the Monitoring Devices can 「eco「d symptoms fo「 more than 24 hours. If the batte「y is running low. the light indicator of the Monitoring Device will start blinking as illust「ated in Figure 24. When the PDMonitorao system is used in hospitals. clinics or healthca 代 envi 「onments it must be disinfected.
App 11.1 Introduction PDMonitor ® mobile application has two versions. one for the Patient and one for the Ca 「egive 仁 • Patient Application: The patient application is 「equi 「ed fo 「 the in巾al patient account 「egistration and device set up. It also allows fo 「 medication intake. nutrition and gene 「al symptom self assessmen甘eco 「ding • Caregiver Application: The ca 「egiver application allows ca 「egive 「s to act on behalf of their patients to 「egiste 「 an account. set up the device.
11.4 Pairing Patient with Treating Physician (Patient Application) If the SmartBox is al 「eady synchronized with a patient account and you want to synchronize it with a diffe 「ent account. o 「 you have no longe 「 access to you 「 C 「edentials you should contact the PD Neu 「otechnology Helpdesk. ＿＿＿ . How do yo, wao t to set,p yooc de,ice' :,�,��"�,��:,�. "''"' bl,etoothgwde e:.�,;:: 芯""''"吓 scaalaggwde "父m叩吵．，请如归四沁印蛐'" 归,....
App 11.6 Login 11.5 Welcome Page The Welcome screen appea 「s only while the PDMonitor ® mobile application is loading (Figu 「e 28). 一 －- a) Privacy Policy During the fi 「st use of the PDMonitor ® mobile application you have to read the Privacy Policy, enabling the·switch Button"• (Figu「e 29) and 巳＿么 tapping on the "Next Button" (Figu「e 30).
b) 11.7 Main Menu Registration You can registe「 through the application form that appea「s when the application starts for the fi 「st time (Figure 31). Upon successful registration. you will receive a confirmation e-ma仆 From the main menu sc 「een (Figure 33) navigate through the application's available features. c) L ogm In the next login attempts. a Login screen (Figure 32) appea 「s where you must provide you 「 account credentials to access the main menu SC 「een.
＿ App • 11.8 Medication By tapping on the medication icon on the main menu screen, you 「 physician's p 「escribed medication list appea 「s (Figure 34). This is a list of medicines to be taken during the day. When you choose a specific medicine. the medicine details appear (Figure 35). Then. confirm whether the medicine has been taken or not. As a result, you can see the updated medication list (Figu 「e 36). ＿ Stale沁ORAL @ DoM200呵.....
• 11.10 Invite Physician/ Patient To use the PDMonitor ® system properly, you need to be paired with a physician. To in巾ate the physician pairing invitation procedu 「e. tap on the Physician icon in the main menu sc 「een (Figure 40). In the next sc 「een (Figu 「e 41). send a pairing invitation (Figu 「e 42) by filling in the unique 6-digit ID you 「eceived directly f 「om your t 「eating physician. After confirmation, the invitation will be sent to the physician.
App • 11.11 Status Afte 「 that. a 「ewa 「d message will appea 「 on the sc 「een (Figu「e 46) to encourage you to keep tracking you「 physical condition on a daily basis. On this sc 「een, you can reco 「d you 「 physical condition ove 「 the previous half-hou 「 (Figu 「e 44). By tapping the ON icon you will be 「edi 「ected to a new screen, asking you about your symptoms (Figure 45).
＿ • 11.12 Profile Fiest name John Last name Smith Age On this SC「een, you can edit and view you「 pe「sonal details. You can also sign out f「om the PDMonitor ® mobile application (Figure 47). 60 Phone Number 6955555555 ．止 13 Stats Ema,IID demo@pdn.com On this screen. you can find a summary of your activity statistics. such as pe「centage of lying down. standing/s曲ng and walking during the day (Figu「e 48). The information fo「 this functionality is gene「ated by the PDMonito卢Monito「ing Devices.
PDMonitor Ad pd mbn itor s a ep p a s e id v a n Parkinson's Disease Videos ® 。 。 ＿ 三 By tapping the info icon CD on the main menu screen. you can navigate to the version page. On this sc 「een you can check the cu 斤ent PDMonito产mobile application version (Figure 50) and the available new updates (Figure 51). t a c u d e h it w 9 n ts · 1 a in 几汾 a e 5 e Tr c er u s 6 a1 q F 1 n od 1 tn a a 1 c 2 u5 11.
。 11.17 Device To 「egister the patient account in the Sma 「tBox. follow the pai 「ing process described in section 11.3. If there is no Ethernet connection. you need the W由code to proceed (see section 11.3.1). If the ala 「m status indicato 「 (Figu 「e 10) is enabled on PDMonitor ® device the use 「 must check the alert message provided at the device screen (Figu 「e 54) in order to handle the e 「ro 「.
App By tapping the ·start Scan" the application will try to connect to PDMonito卢device. Before scanning, make sure that the "Bluetooth" option is enabled. A confirmation dialog will ask your permission to enable the Bluetooth on you 「 mobile phone (Figu 「e 57). If your device is in 「ange and properly detected. a new screen will appear where you need to fill in the W由 details (Figure 58). P「ess the ·connect" button to set the W由 connection to you 「 PDMonito卢device.
Mobile Application Troubleshooting If the application is not responding o「 shows some dysfunction. restart the application. If the p 「oblem pe 「sists. contact PD Neu 「otechnology HelpDesk. System Requirements for Your Smartphone PDMonito卢mobile application is available on iOS (iOS 10 and highe「) and And「oid (4.4 and higher).
Technical Specifications Operating time with full charge Type Charging time to full MD Battery Service Life USB Internet wired c onnection Operating temperature Charging temperatu 「e Operating humidity Water ingress rating for SB Water ingress rating for MD Operating Atmospheric pressure Sta 「age temperatu 「e Storage humidity In Out (length x width x height) (length x width x height) Battery 30h 190 mAH Lithium-polymer, rechargeable, non-replaceable 3h 500 cycles/MD usages Communication Monitoring device U
War 「anty and Se 「vice The PDMonito卢device requires no calibration to operate properly. Should you have any problems operating the device contact: PD Neurotechnology Ltd. fo 「 custome「 support at suppo 「t@pdneurotechnology.com o 「 +30 26510 01300. PDMonito卢system Two (2) Years Limited Warranty. PD Neurotechnology Ltd.
Symbol Table The symbol table contains information to locate and relocate symbolic definitions and references 蛐 产 回 匡 ， % ¢ 口i ——— 48 Manufacturer Date of manufacture Batch code Serial number Fragile, handle with care Temperature limits to which the medical device can be safely exposed Humidity limits Consult the instructions that accompany the PDMonitor ® system The equipment is suitable fo「direct current only
令 IP21 Non water resistant (Water ingress protection) IP22 p「otected against insertion of finge「s and will not be damaged o「become unsafe during a speci一 fied test in which it is exposed to vertically or nearly vertically dripping water IP24 Protected against splashing of water (Water ingress protection) 垒 ＠ + C To identify the positive and negative connections (the polarity) of a DC power supply 心 E:0297 回 尸 冗 Non sterile product Do not use, if package is damaged Keep dry Consult the instruc
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Appendix A: EMC Information PDMonitor ® system Attention should be paid to the following EMC information prior to installing or using the PDMonito卢system. • • ． Portable and mobile Radio Frequency (RF) communication equipment may inte「fere with the operation of the PDMonito「 @ system. The PDMonito卢system has been tested and found to comply with IEC/ EN 60601-1-2. Compute「s. cables and accessories not tested to 60601-1-2 may 「esult in increased emissions o「 dec「eased immunity of the PDMonito卢system.
Guidance and manufacturer's declaration - electromagnetic emissions The PDMonitor ® is intended for use in the electroma gnetic environment specified below. The customer or user of the PDMonitor ® should ensure that it is used in such an environment. Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discha 「ge 2 (E DS IEC 61000-4 土6kV contact 土BkV air 士6kV contact 土8kV air Floors should be wood, concrete or ceramic tile.
Guidance and manufacturer's declaration - electromagnetic immunity The PDMonitor ® is intended for use in the electromagnetic environment specified below. The customer or user of the PDMonitor ® should ensure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the PDMonitor® The PDMonito心is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
Appendix B: Clinical Validation PDMonitor ® system The cu 「「ent ve「sion of PDMonito卢 has been validated through a clinical trial performed in three sites (G「eece. Italy. Germany). The study consisted of two phases. The fi「st phase of the study (Phase I) was conducted in a hospital environment. with detailed (video) monitoring. 「eco「ding and assessment of a wide range of symptoms by experts. The second phase of the study (Phase II) was conducted in a home environment.
PDMonitor® Performance PDMonito卢Outcome Result (comparison to expert rating) Activity/Posture Accuracy 0.93 Bradykinesia R2 = 0.46 Bradykinesia + Gait R2 = 0.79 Wrist T 「emor Detection Accu 「acy 0.89, Cor 「elation R2 = 0.67 Leg Tremor Detection Accuracy 0.93 Gait Disturbances R2 = 0.60 F「eezing of Gait Accuracy 0.93 Postural Instability 0.90 Accuracy with 1 specificity and 0.33 sensitivity in postural instabilit y detection Dyskinesia Presence Accuracy 0.
UK London Office Greece Athens Office Greece R&D unit Greece Production unit PD Neu 「otechnology Ltd 5th floor, 2 More London Rive 「side SE12AP London, United Kingdom T +44 (0)20 7842 8000 suppo门@pdneurotechnology.com PD Neurotechnology Ltd 89 G. Te 「 tseti st 「, Neo Psychico Athens, GR 15451, G 「eece T +30- 2106754796 support@pdneurotechnology.com PD Neurotechnology Ltd Ethn Antistaseos - Kardamitsia loannina. GR 45500.
Monitoring Devices Label 蛐 OR Cede Legal Manufacturer Production Site PD Neurotechnology Ltd. 5th floor, 2 Mo「e London Rive「side London, SE 12AP United Kingdom PD Neurotechnology Ltd. Ethn. Antistaseos - Kardamitsia loannina. GR 45500 Greece www.pdneurotechnology.
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