FCC ID: 2AZDG-PDMONITOR PDMonitor

pdnfbnitor ENGLISH INSTRUCTIONS FOR USE Vesion:0.9 I Mach 20, 2020 powered by pd neurotechnology medical solutions CE:297 2 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. NOTE: This equipment has been tested and found to comply with the limits for a Class harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against If this equipment does cause harmful interferenceto radio or television

Radiation Exposure Statement This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This e your body. quipment should be installed and operated with minimum distance 20cm between the radiator and Copyright manual. may be reproduced. ansmitted. optical. Nopatof this publication mechanical. chemical. of our product. This document evisions This item is compliant No part of this wokcan be disseminated may contain of this document. inaccuracies technical with the Medical Device or otherwise without Directive 93/42/EEC of 14 June 1993. transcribed. stoedinaetievalsystem. prior written consent for other purposes translated of PD Neurotechnology into any language or computelanguage. in any fom.by any means. electronic, Ltd. This publication is to be used solely for the puposeof reference or operation otypogaphicalerros.Contents of this document aesubject to changes without prior notice. Changes will be incorporated in tutu II:> 2020 PD Neurotechnology Ltd. All rights reserved. 3 Contents Use Intended 6 8.2 Placing the Monitoring Devices on the Contra indications Warnings Precautions 6 7 SmartBox after the RecodingPeriod 26 8.3 MonitoingDevice Light lndicato Functionality 32 Package Contents 10 PDMonitoSystem 14 System Maintenance 32 9.1 Cleaning Monitoring Devices 32 9.2 Disinfecting ManitoingDevices 32 Setup Instructions 15 9.3 Cleaning the SmatBox 33 7.1 Unpacking the PDMonito System15 7.2 Configure to the SmartBox Cloud PD Neuotechnology 16 7.2.1 Registe viaEthenetCable 16 7.2.2 Registe viaWi-Fi 7.3 SmartBox Light lndicato ID Monitoring Device Usage 19 8.1 Placing the ManitoingDevices Troubleshooting 33 10.1 Troubleshooting SmartBox 33 10.2 Troubleshooting MonitoinqDevices 33 10.3 Possible Damage 16 17 App 11. 1 Intoduction 11.2 Installation 33 34 34 34 34 on the Body foaNewRecoding 20 11.3 Setup 4 11.3.1 SmartBox Internet Connectivity 34 11.16 Taininq 11.3.2 SmartBox Account Synchronization 34 11. 1 7 Device 35 11. 18 Wi-Fi Setup Toubleshooting 36 Mobile Application 36 36 System Requirements 37 37 for YouSmartphone 37 '-1'

38 '"7 Technical Specifications 46 Warranty and Service 47 Disposal Version Symbol Table 11.4 Paiing Page 11.5 Welcome 11.6 Login a.PivacyPolicy b.Registation c.Login 11.7 Main Menu 11.8 Medication 11.9 Nutition 11.11 Status 11.12 pofile 11.13 Stats 11.14 Message of the Day 11.15 Vesion 11.10 Invite Physician/

Patient 38 39 40 41 41 41 42 42 43 44 45 45 47 47 48 5 Intended Use Disease system for the continuous is a non-invasive monitoring to trace, ecod, with Pakinson's and stoea variety continuous

(PD). It is intended PDMonitor patients process of motosymptomsfequently use of a set of wearable PD through Comprehensive movement information well as information following The system can be used at any stage of the disease diagnosis PDMonitosystemconsists and the PDMonito Devices of the SmartBox. mobileapplication. on disease symptoms data processing, taken fomtheecordings as and their intensities is, physician afteitsinitial teatment.The in occurring MonitoingDevices. and when the patient sent to the treating five (5) Monitoring appropriate is under medical The devices Monitoring data for assessing Devices. body-motion The PDMonitor body and acquire symptoms. The PDMonitoSmatBox.The PDMonitoSmartBoxis a small storing collecting, station and them to and uploading processing the PD Neurotechnology the data from all Monitoring storage Devices. Devices

(Cloud). aemounted the PD moto the Monitoring for charging service on the mobileapplication. is an electronic The PDMonito application elatedto PD. Moreove,the PDMonitor summary of daily activity Addionally, assessment disodersand collection can be also used the PDMonito The PDMonito diary for medications. mobile application as recodedby the PDMonitosystem. and symptom esearchin movement deviceecordings foclinical povidesa of motion/ movement data. diet and symptoms mobile systemshall PDMonito who is registered physician system PDMonito be used only after the approval to PD Neurotechnology Ltd. in the use of the of your treating Contraindications

<D Do not use this system with a defibrillation

<D Do not use this system during

<D Do not use duingmedical

<D Do not use this system when patient MRI scanning. is in a clinical device. procedues. imaging depatment with high radiation.

<D Do not use this system with a pacemake

<D Do not operate this system in an environment

. containing flammable anesthesia gas.

<D Do not use it with other devices with high levels of electromagnetic adiation in the vicinity

<D Do not use the PDMonitoMonitong Device. Devices of the Monitoring and all the povided

<D Befoeexercise. accessoiesfomorethan 24 houscontinuous it isecommended physician use. from your treating PDMonitor affect on the coectInstructions for Use of for Use could the propeInstructions evaluation. qua I ity and extactedsymptom the measurement Faingto follow advice that you seek appropriate 6 Warnings damage the system. CD Do not use the system on an open wound. CD The environment where the device is used should be CD Tripping paths. walking Hazad -keep the electrical codaway from feefrom vibration. dust. coosiveo combustible

<D Do NOT expose the SmatBoxto liquids. This may permanently easonably matter CD Should theebe an allegicreaction and avoid extemesof tempeatueand humidity. emove of the affected o skinirritation. pictures the Monitoring Device. aeasand keep detailed Then. take notes on the symptoms. CD All adverse events or side effects to PD Neurotechnology and repotthecase. to analyze immediately be reported Ltd. Ltd. This will help PD Neurotechnology should CD PDMonito biological doesnot administe products. anymedicinal. o chemical CD PDMonitodoesnot provide treatment o recommendations instructions. CD PDMonitor CD A consultation necessity by your teatingphysician use of the PD Monitor fotheappropriate is able to monito PDsymptoms walking. is an absolute system dunga range of When peformingintense including fitness daily activities activity

(running. theteatingphysician bicycling should etc.) it should either be infomedabout those activities. beemovedo CD Operate the system within humidity from 5C to 35C. If the stoaqe/transpo of 40%-80%

relative and temperature conditions the device before connecting exceed the suqqestinq stand fo atleast 30 minutes limits. let e at room temperatu operating it to the power supply.

<D PDMonitor should not be used unde anyother medical procedu (MRI.CT Scan, PSU, etc.). CD If the powe supplyunit is damaged, do not operate the system

(the PSU green led light is off even when this is plugged electicalsocket). in the CD The PDMonitor Monitoring Therefore. ousedduring swimming, NOT waterproof. liguids duringany undewateactivity. Devices they should not be exposed and to bathing showering, are water resistant CD Use only the accessories provided foPDMonito system CD Do not disassemble oemodelthe SmatBoxor/and the MonitoingDevices. CD PDMonitoMonitoingDevices include rechageablelithium polymer batteries. Storage, instuctedenvionmental use and tansportation and/orexposu conditions e to outside the 7 heat ofiremay result chemical explosion. excessive damage. punctu0burnas doing so canesultin fire, eleaseof toxic gases. leaking. damaged, irregula

. Do not use the device discolored. misshapen. explosion othe if it appears to be oinany way in inceasedrisk of device burn or fire. Do not crush. CD PDMonitor in radiology should NOT be used near radiology departments. o modalities Precautions CD Do not leave PDMonitor Monitoring Devices unattended. They must be eithewornodockedin the SmatBox. CD PDMonitoMonitoring Devices should be tightly fitted on CD If there are any signs of material degradation on the Monitoring the body. otheSmartBox. Devices PD Neurotechnology HelpDesk www.pdneurotechnoloqy.com). avoid using the system and contact at

(available CD Do not use PDMonitosystem Devices CD PDMonito

(magnetic Monitoring accessories magnetic should not be worn nea watches etc.) bracelets. USB ports for othedevices. CD You can only use the PoweSupplyUnit (GSMZ5E05-PIJ) system. with the PDMonito supplied CD If the device is not going to be used foalong period. that the PDMonito systemis safely shutdown. it is a mobile device. ecommended through CD PDMonito system) accordance ecommended CD The medication an exhaustive given time. The PDMonitor to be used as a medication may reach temperatures system(Monitoring Devices with 60601 11. 1. 1.2 and theefo fousewith infants are part of PDMonitor of more than 41c in isnot or othehighrisk groups. list in the PDMonito list of medication you could be pescribed mobileapplication is not at any is not intended mobile reminder application to beeliedupon. CD Clean PDMonitoMonitoring to the instuctionsin section 9. Devices and SmatBoxaccong CD Keep infants and childenaway from PDMonitor accessories topeventsuffocation ochoking. CD Please keep the PDMonitor device from dust and liquids transpotation. lid on at all times to protect and use the supplied you bag fo and regulatory For more safety disposal Environmental Notices 16 and Appendix)

(see section and for battery infonmation and refetothe Regulatory Safety Ltd povidedby PD Neurotechnology information, 8 9 Package Contents Photo Description Qty. SmartBox SmartBox lid Monitoring Device 5 10 Photo Description Qty. Clipframe Strap frame 3 Wristband 2 (small to medium) 2 (medium to large) 11 Photo Description Qty. Hook and loop strap 2 (small) 1 (large) Power supply unit

(GSM25EOS-P1J) Ethernet cable 1 1 q pdmbnitor INSRUC1IONS FOR USE

12 Instructions for Use Photo Description Qty. Videobook 1

Videobook charging use cable Carrying Bag 13 PDMonitor System SmartBox 1) is the PDMonito

(Figure The SmartBox Devices Neurotechnology the PDMonitor storage Monitoring service Devices. should be placed to upload theidatato the PD

(Cloud). The SmartBox also charges unitwhere the Monitoring Monitoring Device light Indicator Monitoring Device micro USB port Figure 1. PDMonitor SmartBox Figure 2. PDMonitor Monitoring Device Accessories strapframe The wristband. secuethe Monitoring ae fowrists. strapframes lagestrap, and of the accessories clipframes and clipframe

(Figue3) aedesigned to Wristbands Devices to predefined body places. foshanks(legs) fowaist.Detailed 8. 1 . are given in section and fowaist.along with the on the usage instructions OFigure 3. PDMonitor"

accessories for mounting waist and le on wrists, Monitoring Devices Monitoring Devices are used to measuebody daily life activities. during Devices The PDMonitoMonitoring movements All Monitoring Devices chagingand communication MonitoingDevices accessories. have a light indicator purposes. and a micro USB potfo as shown in Figue2. are mounted on the body with PDMonito 14 5.All Monitoring Device the SmatBoxshould indicato status s on off (Figue5) be switched light Power status light indicator Setup Instructions via an Ethernet connection be registered requiesan Internet either propely. The SmartBox cable or an available W networkto function Toeceivethe full benefit SmartBox should paired the device. eatingphysician.

(section 11 .4). 7.1 Unpacking with an account. who will evaluate of using the PDMonitosystem.the which in turn will be the data produced by and paiwitha Instructions the PDMonito System with a teatingphysician on how to create the PDMonitor an account Fodetails consult for Use All Monitoring Devices should be fully chagedbefore use. 1.Unpack the contents of the box 2.Place all components on a flat surface 3.Connect 4.Connect the powesupplyunit to the power outlet 4) the powecordto the SmatBoxadapter

(Figure and find a nearby power outlet Device Monitoring status light indicator Figure 5. Top View of PDMonlto SmartBox Power adapter LAN adapter 6. Place the Monitoring on the Devices SmatBoxas shown in Figue6 figure 4. Rear view of PD Monitor SmartBox Figure Devices 6. Placing on the SmartBox PDMonitor Monitoring 15 7.2.2 Register 1. Connect via Wi-Fi to the power outlet the SmartBox 7. The Monitoring Monitoring Device start charging. orange. is flashing Devices When charging, each SmartBox to the Cloud 7.2 Configure PD Neurotechnology The SmartBox must be connected stoageservice (Cloud) Ethernet Internet cable or an available connection. to be properly to the PD Neurotechnology eithevia configured an Wi-Fi netwok.This requires 2. Fol low the step-by-step procedu e onthe PDMonitor with the mobile fothePDMonitor to paitheSmartBox This is necessary to be used to send the Wi-Fi credentials and allow it to connect It is advisable to the same Wi-Fi, mobile phone via mobile to the to the available Wi-Fi is already application Bluetooth. application SmartBox network. connected 11.18).

(efetosection howevethisis not necessary that the mobile device

'" systemis now ready The PDMonito advice consult on how often your treating and to wear the monitoring physician for use. Fadetails devices, please 7.2.1 Register 1. Connect 2. Connect one end of the Ethernet the SmatBoxto the poweoutlet via Ethernet Cable cable to the SmartBox LAN wall. adapte(Figure4) and the otheendto an available modem or routeLANplug 3. Follow the step-by-step procedueonthe PDMonito mobile application Bluetooth 11.3)andegisteran account to pair the SmartBox

(oanyof the otheoptionsdescibedin section on the Smart Box. with the mobile phone via please If you do not own an Andoidor iOS SmartPhone, for you. HelpDesk PD Neurotechnology your device to setup contact 16 7.3 SmartBox Light Indicator In this section. the light indicator

functionalities of the PDMonito SmartBox are described at Figure 7. 8. 9 and 10. Power status light indicator n h dicato t i Lig Monitoring Gree r r n colo Device light status indicator State Co n Co ge Flas n ctio Fu n r n is ful ly e inc ev g D i o it Mo r h d d fo e a a is c 3 r y s r u a e e n r n Mo i t o D ni g e v e ic n r h od i g a g a d a t a u p i s c o m t e d e l n n itor Mo i ng is Device n h r g g Lonac di d i g a a L

. ta a It HOU ot be removed n 1 u n sta n sta n h g i n t n t is Load c d c n ge Ora n Ora O FF n n t sta Co n n g Device is itori Mo n n ected disco 1 2 3 4 r r Lig n h dicato t i 1 G 2 O n n t sta Co n n t sta Co n r ge a State colo r ee T T n n ctio Fu n h e S martBox is powered o n h e S matBox is starti up n g 3 O FF n n t sta Co Power off Figure 7. Monitoring Device light status indicator Figure 8. Power status light indicator 17 Setup Instuctions Internet connection light indicator Alarm status light Indicator Light indicator color Blue Constant State Function Internet connection is available OFF Constant No Internet available connection 1 2 State Light indicator color 1 Function The PDMonitor is NOT functioning ro c ec p st n a ou m u d y onitor mobile h t e P D M n tio fo r ppmli ca a ion and t e rm a mo A List of warnin alerts. Constant Red fo is included in Device screen (refer to section 11.17) make sure that all light indicators aegreen befoeusing Please the PDMonitor"

Monitoring Devices. 2 OFF Constant PDMonitor is working properly Figure 9. Internet connection light indicator Figure I 0. Alarm status light indicator 18 Monitoring Device Usage PDMonitosystemrecords only while Monitoring locations. PDMonito aechagedand the light status indicates Devices 7) are green. that PDMonitosystemiseadyfoanewrecoding. indicatos

(Figure This the symptoms of Parkinson's Disease aemounted on pedefinedbody shallonly be used when all MonitoingDevices system The PDMonitor"

Device status light indicators

(Figure 7)aregreen is ready for use only when all Monitoring Waist Monitoring Device The PDMonitosystemshould be used only with the strapfames. in the original straps, wristbands clipframe. PDMonito packaging, povisioned or eguivalent Ltd. by PD Neuotechnology included components and power supply official systemshould The PDMonito sta pframes.clipframe. straps device pedefined and the MonitoingDevices body locations. only be used with the with the provided in all be placed and wristbands should Place period the Monitoring is finished. Devices on the SmartBox after the recording 11. The body parts that PDMonitor ce Monitoring Devices should be Figure worn 19 ManitoingDevice Usage 8.1 Placing on the Monitoring the Body for a New Recording Devices Monitoring Devices foPDMonitor systemto function must be placed on specific Those properly. 11. The following section body locations aedepicted in Figure The five (5) PDMonito body locations specific describes in detail how to propelymount the Monitoring Devices. Monitoring Devic;es Wrist position Put the two MonitoingDevices 12 the left and right wistas shown in Figure Undock the MonitoingDevices from the SmatBox using the appropiatewistbands on Secue theMonitoing Devices to the wistbandas shown in Figure 13 Put the Monitoring comfortable Devices yet tight fitting on your wrist and make sure that they are The Monitoring Devices startecongautomatically. The wristbands should complications. emovethe wristbands not be too tight If you statoexperience and contact skin redness or irritation. Ltd PD Neurotechnology to avoid othehealth 20 Figure 12. PDMonitor Monitoring Devices on wrists Wrist position Monitoring Devices Figure 13. Instructions on mounting PDMonitor"

Monitoring Devices on wrists using the wristband 21 Monitoring Device Usage Leg position Monitoring Devices Place the two Monitoring and straps on the left and right leg as shown in Figue14 Devices using the appropriate strapfames Undock the MonitoingDevices from the SmatBox Secuethe Monitoring Devices 15 by sliding the Monitoring to the strapframe inside as shown in the frame and Devices Figure then pushing

"clicking the strapframe sound or feeling Place the Monitoring Devices on the hand occurs in the correct sides until a characteristic automatically. as shown leg position. TheMonitoingDevices start recording 15 in Figure The leg straps should complications. emovethe straps please not be too tight If you start to experience and contact skin redness PD Neuotechnology Ltd to avoid othehealth or irritation 22 Figure 14. PDMonitor Monitoring Devices on shanks Leg position ManitoingDevices 4 Figure 15. Instructions on mounting PDMonitor Monitoring Devices on shanks using the strapframe 2 5 3 23 Monitoring Device Usage Waist position Monitoring Device weathelast (fifth) You should using the provided position position

(Figure stapfameand strap to the waist Monitoring Device fothewaist clipframe to the appropriate body 16). Anothewayto wear it. is with the appropriate Undock the Monitoring Device Secure the MonitoingDevice to the clipframe from the SmartBox the Monitoring Figure 17 by sliding and then pushing soundofeeling Device the clip sides until a characteristic on the hand occu Wear the MonitoingDevice fitting on youwaistand make sure that it is yet tight comfortable inside

"clicking"

as shown in the clipframe TheMonitoingDevice start recording automatically. pay attention mly inside You should Devic e fir the clip sides until feeling on the hand occuS the clip! ameand pushing

"clicking"

sound or a characteristic to securing the Monitoring 24 Figure 16. PDMonitor

'" Monitoring Device on waist Waist position Monitoring Device 2 5 4 Figure 17. Instructions on mounting PDMonitor Monitoring Device on waist using the clip 25 Monitoring Device Usage 8.2 Placing SmartBox the Monitoring after the Recording Devices Period on the Aftetheecording take off the Manitoing Devices and put them back in the time recommended by youeatingphysician. SmartBox. While flashing, PDMonito SmatBox.the coresponding orange. should not be removed completed indicato and the PDMonito s willturn When you place the Monitoring light status Monitoring indicato Devices are uploading Devices in the shouldstart flashing their data and from the SmartBox. devicesare fully When data transfe chaged, is the light status geenand the device iseadyfoanewecording.

2 figure 18. Instructions on removing PDMonitor

'" Monitoring Devices with wristbands from wrists 5 6 26 Wrist position Monitorin9 Devices Device Remove each Monitoring from the wristbands

, as shown in Figure 18 Place the Monitoring Devices into the slots of the SmartBox

, as shown in Figure 19 4 5 Figure 19. Placing Monitoring Devices into the slots of the SmartBox 3 6 27 Monitoring Device Usage Leg position Monitoring Devices Remove each MonitoingDevicem the strapframes, as shown in Figure 20 Place the Monitoring as shown in Figue21 Devices into the slots of the SrnatBox. 2 5 3 6 4 Figure 20. Instructions on removing PDMonitor"

Monitoring Devices with strap frame from shanks 28 Leg position Monitoring Devices Place the MonitoingDevices into the slots of the SmartBox 3 Figure 21. Placing Monitoring Devices into the slots of SmartBox 29 Monitoring Device Usage Device Monitoring Waist position Remove the Monitoring as shown in Device from the clipframe.

, Place the Monitoring Device into the last slot of the SmartBox. as Figure22 shown in Figue23 t t 2 5 3 6 Figure 22. Instructions on removing PDMonitor

., Monitoring Device with clipframe from waist 30 Waist position ManitongDevice Place the Monitoring Device into the slot of the SmartBox Upon placing While flashing the Monitoring orange. the devices into the SmartBox not be removed the coresponding from the SmartBox. Devices should light status indicator should start flashing orange. figure 23. Placing Monitoring Device into the slot of the SmartBox 2 31 Monitoring Device Usage System Maintenance 8.3 Monitoring Functionality Device Light Indicator 9.1 Cleaning Monitoring Devices The functionality Figue24. of the Monitoring Device light indicato isshown in Monitor Device light indicator should be regularly Devices To clean each Monitoring The Monitoring activity. be avoided. SCubbingwith a soft. wet cloth. Device. Use a soft towel peferably. cleaned household afteanyintense cleansesshould try For tough spots ostains. 9.2 Disinfecting Monitoring Devices solution Abrasives of the Monitong A disinfecting a soft cloth. surface emovedby wiping to the Monitoring can be applied should be avoided Devices. Devices. as they could damage the fluid is Ensuethat all cleaning using each Monitoring Device caefullywith a soft cloth. Light indicator

# I State color Enabled for 3 seconds 1 I Blue when I device quickly 2 I Blue Flashing every 1 second turned towards pa-

face tient's Function Monitoring properly working Device is Monitoring Device battery Charging is low. is needed Figure 24. Monitoring Device indicator functionality light 32 9.3 Cleaning the SmartBox The SmartBox should cleansers can be cleaned be avoided. by using a soft damp towel. Household When the PDMonitor envionmentsit must be disinfected. being egulalyand especially after clinics is used in hospitals. used by each individual solution using disinfecting patient. or healthca ao system Troubleshooting 10.1 Troubleshooting SmartBox Afteplugging the fol lowing seguence of events should occu:

the powecableand the Ethernet Cable in the SmartBox. 1.The light indicator

(Power) will turn on and the color will be orange forno more than 5 minutes 2.Then. the fistlight will be blue.

(Internet) indicator(Powe

)will staygeenand the second this fail to happen. Should unplugged Neuotechnology and re-plugged. HelpDesk. the poweandthe Ethernet should be the PD If the eorpesists.contact cables After a full charge than 24 hours. Device Monitoring the Monitoring Devices If the batteyis running as illust canecodsymptoms low. the light indicator 24. atedin Figure blinking will start fomore of the physician. AftetheMonitoingDevices treating ecordeddata. When all five Monitoring SmatBox.the following by the on the SmatBoxto upload the are placed on the have been worn fothehousindicated they must be placed Devices should occur:

1.FoeveryMonitoring Device its coresponding data). light should indicator indicato orange (chagingand uploading be blinking does not turn orange. check that the Monitoring docked. If the light plug again the powesupplyof the PDMonito SmartBox. Neurotechnology Device Undock and dockthe Monitoring not orange, onthe SmartBox If the problem HelpDesk If the light Device pesiststhen you should and the deviceto restart the PD contact in the SmatBox. unplug indicato is poperly is still 2.When the light have been uploaded indicator orange is a constant Devices and the Monitoring it means that the data are charging 3.When the light indicato isa constant geenthe corresponding iseadyforuse(chagingand data uploading Monitoring could Device last toupto 3 hou. If aftemorethan theehours the light indicators PD Neuotechnology on the SmatBoxdo notturn geenthen contact HelpDesk. the 10.2 Troubleshooting Monitoring Devices 10.3 Possible Damage be placed Aftethesuccessful should The Monitoring light on the SmartBox Devices indicato setup of the SmatBox,the Monitoring to be fully chagedfor the first Devices time. aeready for use when each coesponding onthe Smart Box (Figue9) is a constant green. If any kind of damage is detected be placed Monitoring HelpDesk. the PD Neurotechnology Device cannot on any of the Monitoring oa Devices on the SmartBox correctly, contact 33 App 11.1 Introduction mobile PDMonitor and one for the Caegive application has two versions. one for the Patient a)Ethernet:

SmartBox with a patient account in section As described needs to be connected 7.2 before to the Internet its first and synchronized use. the Patient Application:

The patient accountegistration application and device isequiedfothe nutrition set up. It also allows and genealsymptom self inalpatient fomedication assessmeneco intake. ding Caregiver Application:

of their patients The caegiverapplication toegisteanaccount. egang information allows andecodcomplementary caegivesto act on behalf set up the device. medication. nutrition and symptoms. the PDMonitor open the Google Play Store/

11.2 Installation To install device.

"PDMonitor fouse. 11.3 Setup 11.3.1 SmartBox Internet app". Then. the PDMonitor mobile mobile application Apple App Store on an Android/

iOS for and search application iseady Connectivity As described in section be connected to The PDMonito the Internet mobileapplication its fistuse. the SmartBox with a patient needs to account. and synchronized must be used fothat:

7.2 before b)Wi-Fi:

If Wi-Fi is suppotedand prefered,the PDMonitmobile of the Wi-Fi 11.18. must be used to send the cedentials to the SmartBox. account application connection Then go on to SmartBox For Wi-Fi set up, see section synchronization. 11.3.2 SmartBox Account Synchronization Asdescibedin section account. account. There aetheeways to configure using the PDMonito with an needs to beegistered the SmartBox patient 25):

mobileapplication

(Figure 7 .2 the SmartBox Bluetooth:

This sceenopens a wizard that guides the user to setup the device QR Scan: This screen found in the PDMonito shows how to use the QR code that can be systemoriginal

(Figue26) packaging Manual input:

On this screen. to the QR the numbecoresponding code which can also be found in the PDMonitosystem's packaging can be manually fi lied in (Figue27). oiginal 34 with Treating Physician

(Patient Application) 11.4 Pairing Patient A egisteedphysician contacting physician Once youphysician mail that the pairing Caregiver sceen(Figure owns a unique ID. You can obtain this ID by youeatingphysician diectly. You can then use the

(section invitation 11.10). 41) to send a pairing the pairing accepts was successful. invitation, you willeceivean e with Patient

(Caregiver Application) this e-mail YouPDMonitoaccountis linked caegivemustobtain mail in the Patient invitation. mobile application, that the paiingwas successful. sceen,youcaregive Once you accept the invitation by directly through will inform the caegiverapplication youPDMonito youcaregive up with youuniquee-mail. you. Using this e contacting You canthen send you a paiing If the SmartBox want to synchronize to youCedentials access is aleadysynchronized with a patient it with a diffeentaccount. contact you should

"m'"

Helpdesk. How do yo, waot to set,p yooc de,ice' . :,, ",:,.

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gwde bl,etoothgwde scaalag nw

,.... and you account oyouhave no longe the PD Neuotechnology Athesenal o ,mbe, yo, caodio thepack,gehe<e Mao"'lly Set,p yo"'d""'"

se,1,1 o,mbe, by te<tiog the Figure 25 Figure 26 Figure 27 35 App 11.5 Welcome Page sonlywhile the PDMonitor The Welcome screen appea e28).

(Figu loading application is mobile mobile application you have to read Button" (Figue29) and 11.6 Login tapping a)Privacy Policy During the fi the Privacy theswitch stuse of the PDMonitor enabling Policy, on the "Next Button" (Figue30). application. -

Please contains using the PDMonito Policy you need to be aware of when make sure you read the Privacy systemand the PDMonitor infomation important carefully mobile as it Privacy Policy 23, 2019 Privacy Policy 23, 2019 Last updated:

May Last updated:

May PD NEUROTECHNOLOGY PRODUCT PRIVACY POLICY LTD PD NEUROTECHNOLOGY PRODUCT PRIVACY POLICY LTD SECTION A: IMPORTATION AND REQUIREMENTS SECTION A: IMPORTATION AND REQUIREMENTS This section followlng topics contains Information on the I have read the Pnvacy Polley l the Pn,acy Poncy I ha,e ,ead 29 Figure I I Next 30 Figure 36 Figure 28 b)Registration 11.7 Main Menu You can registe starts application you will receive registration. throughthe application for the fisttime (Figure a confirmation e-ma form that appeaswhen the 31). Upon successful From the main menu sceen(Figure features. application's available the 33) navigate through c) L ogm In the next login attempts. a you must provide

(Figure Login screen youaccountcredentials 32) appeas where the main menu to access SCeen. I E-Mail i Confirm Password First name i Password

\,. Phone rent pd monitor Welcome!

Please enter your credentials to access the application Please enteyour e-mail Please enter youpassword pdmonitor 0 Med,oat,oo Notot,oo""

Message Physocoaa Pmfole Tram mg Status Stats Already ha,e an account'

Sign in Not a Member?

Register Figure 31 Figure 32 Figure 33 37 App 11.8 Medication 11.9Nutrition pescribed medication By tapping on the medication youphysician's is a list of medicines specific confirm can see the updated medication icon on the main menu screen, list appeas(Figure 34). This to be taken during the day. When you choose a appear (Figure 35). Then. has been taken or not. As a result, medicine. whether the medicine the medicine list (Figue36). details you By tapping the nutrition icon in the main menu sceen.you can change the time of youlastmeal by tapping the clock icon (Figue37). By setting the time and clickin poductsoothepoducts(Figure 38) and you the food in potein-based must recod the food you ate 2 housbefore and 1 hou afte taking medication The sceenin Figue39 is also loaded as a patof the medication functionalit g the OK button y, aftetheSCeenin Figue35. the next screen separ-ates

StaleORAL StalevoORAL

,Ip-ORAL DoM200.....,oo Stale,o Don, moot06c30 200 mg 0oH0'12'00 Oral

StalevoORAL Dose200 Don0....., .. @

H200ITl!I 10600 Requlp -ORAL StalevoORAL What did you eat at II Next

DoM,00 ...,,,ttBOQ se200m; >t18:00 Stale,oORAL e 200'Tl9 > 11 12 00 Oose3 mgt06 30 Did you take?

S11 ORAL Stale,o-ORAL at 06 00 Stalevo mg>10000 06.00

-ORAL

Nutrition From 04 00 to 07 00

@()seafoods Meats Dy/Egg e@

@a

Seafoods Meats Dairy/Egg

Other Nothing Other Nothi OK OK Nutrition From 04 00 to 07:00 figure 34 Figure 35 figure 36 figure 37 Figure 38 Figure 39 38 11.10 Invite Physician/

Patient system properly, To inatethe physician To use the PDMonitor a physician. tap on the Physician next sceen(Figue41). send a pairing filling teatingphysician. icon in the main menu sceen(Figure invitation ID youeceiveddirectly you need to be paired invitation procedue. 40). In the in the unique 6-digit pairing

(Figue42) by fomyour with the invitation will be sent to the physician. Once the pairing invitation. in the next sceen accepts After confirmation, youphysician

(Figure slightly right-hand 43) you will see that the Physician alteed,with a geentick makappearing icon in the main menu is at the top cone,indicating a successful pairing. The same procedure invite you by flingin youuniquee-ma can be followed by your caregive to pdnfonitor 0 Enter youphysician's PDMonitor PIN*

*contact your physician 40 Figure Figure 41 42 Figure Figure 43 pd /, . m!>rntor CD 5

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(Figue44). By tapping new screen, you about your symptoms asking 45).

(Figure the ON icon you will beediectedto a condition ovetheprevious Aftethat.aewadmessage will appeaonthe sceen

(Figue46) to encourage condition you to keep tracking on a daily basis. youphysical How did you feel the half hour previous OFF en CV to medication Good response Dysk;oes;, No Dysk;oes;, med1cat1on medicatlOn Bad, there are side Good, no side effects effects to Bad response Good response to 40 44 Figure 45 Figure 46 Figure 11.12 Profile On this SCeen,you can edit and view youpesonaldetails. also sign out fomthe PDMonitor mobile application You can

(Figure 47). 13Stats you can find a summary of your activity statistics. On this screen. as pecentageof lying down. standing/sng day (Figue48). The information Devices. the PDMonitoMonitoing such and walking during the is geneatedby fothisfunctionality 14Message of the Day You can send messages to youeating paired physician

(Figue49). messages to your disease. to your treating This f unctionality should only be used to send short communication relative Be advised, othethan contact asynchonous emegencies.hould This is telephone oe-mail. be used for and should not not be used for emergencies communication the physician you directly through has no way toespondto the messages, paiedphysician. Fiest name name John Smith Last Age 60 Phone Number 6955555555 Ema,IID demo@pdn.com 0 Mal, 0 F,m,1, 0 O<

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Add your daily Figure 48 Figure 49 41 App 11.15Version to the version the info icon CD on the main menu screen. you can page. On this sceenyou can check the 50) and mobileapplication version

(Figure By tapping navigate cuentPDMonito the available new updates 51).

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in i n a Tr 1 6 1 1 c c n t a a e u 1 r o s a n e q 5 5 u d 2 F e 9 1 a n t s c t a e d u hitw n a a a e pp e s idv s pd mbn itor PDMonitor Copyright Version Check for updates 42 Parkinson's Disease Videos PDMonitor Ad

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Figure 50 Figure 51 Figure 52 Figure 53 in the SmatBox.follow 11.3. If there is no Ethernet 11.3. 1). If the alam device the use on PDMonitor

(see section the paiing connection. 1. 2. at the device screen (Figue account described in section W codeto proceed

(Figue10) is enabled Toegisterthe patient process you need the status indicato must check the alert message provided theero. 54) in order to handle If the device is not PDMonitosystemis safely application mobile used for a long period,

(Figure shut down through it is recommended that the the PDMonitor 3. Internet connection appears to be offline. The Monitoring Devices worn nor placed on the Possible warnln are neither SmartBox. please contact HelpDesk. A problem occurred, PD Neurotechnology 11.17Device 55) You have successfully fi registered a PDMonitor device'

(s.nalN

A I Code 1 I Internet connection appears to be offline Figure 54 Figure 55 43 App 11.18 Wi-Fi Setup To Setup the Wi-Fi connection sure that your mobile phone is already Then. in the main menu of the PDMonitor Device 56). right (Figure in youPDMonitodevice.first connected mobile make to a Wi-Fi netwo press the the W menuon the top icon and on the Device screen. select application. Scan" the application will try to connect to option make sure that the "Bluetooth"

will ask your permission to enable is enabled. the Bluetooth A on dialog thestart By tapping PDMonitodevice. Before scanning, confirmation youmobilephone (Figue57). If your device detected. details

(Figure connection connection to youPDMonito indicator light a new screen is blue (Figue9). device. will appear where you need to fill in the W button to set the W 58). Pesstheconnect"

Finally, check that the Internet is inangeand properly Pairing with your Sma!Box

"""-9

WIFI coooectloo Set,p Name (SSID): NameSSID Password:'"'" passwo,d Show Password An app is asking to turn on Bluetooth Deny Allow Figure 56 44 Figure 57 Figure 58 Mobile Application Troubleshooting If the application the application. HelpDesk. is not responding If the poblempesists.contact restart oshowssome dysfunction. PD Neuotechnology System Requirements Your Smartphone for PDMonitomobile and Andoid(4.4 and higher). application is available on iOS (iOS 10 and highe) 45 Battery 30h 190 mAH Lithium-polymer, 3h 500 cycles/MD usages rechargeable, able non-replace device USB port for the connection with the SmartBox Technical Specifications time with full charge Operating Type Charging MD Battery time to full Service Life USB Internet wired c onnection Operating temperature e temperatu Charging humidity Operating rating for SB Water ingress Water ingress rating for MD Operating Atmospheric pressure Staagetemperatu humidity Storage e In Out

(length x width x height) Storage/Trans port Environmental Conditions Communication Monitoring R45connector General S-35C 0-35 40-80%

1Px21 1Px24 700 hPa to 1060 hPa

-lD-6()0(

40-80%

Power pply 230VAC/0.35 SVDC/4A A SmartBox size Monitor device size

(41 x31 x 12.5) mm Sensors 9 DoF IMU sensor

(length x width x height)

(168x74x43.5)mm 46 This section contains the technical specifications of the PDMonitor mi system. Warantyand Sevice Disposal The PDMonito Should devicerequires no calibration to operate properly. you have any problems operating the device contact:

PD Neurotechnology suppot@pdneurotechnology.com o+3026510 01300. PDMonitosystemTwo (2) Years Limited Ltd. focustomesupportat Warranty. Ltd. warantsthe PDMonitor

) against defects in accordance System banded and in materials with the PDMonitor PD Neurotechnology hadwareproduct

(PDMonitor workmanship published original Period"). when used normally guidelines foapedof TWO (2) YEARS from the date of etailpuchaseby the end-usepuchase("Waanty PD Neurotechnology PDMonitor will be uninteuptedoerroee. Ltd. does not warantthat the operation of the of European Application 2003/108/EC.2011/65/EU use of dangerous gabagedisposal. substances diectives2002/95/EC. 2002/96/EC. in the and 2012/19/EU. fo eduction and for and electonicdevices in electric that at indicates It must therefore for electicand electonicgarbage or its packaging must not be disposed be delivered on the device life the product The symbol appearing the end of its useful waste. with domestic collecting theetaile sepaatelyprevents the case of impropesposal. with cuentstandadswill apply. The device for disposal. as appopriate. regulations. centers whenpurchasing potential a new device. environmental administrative Disposing and health sanctions and its patsae maked with national 1n accordance of together to the competent o etumeditto of the or regional product hazads.In in compliance systemfail to wokproperly during its useful contact the PDMonito Should PD Neurotechnology life. arangeforepaiand/orreplacement. parts. Ltd .. at + 30 26510 01300 to Theeare no use-serviceable Version Removal waantyof the device. of the void waantylabel from the SmartBox voids the PD Neurotechnology Ltd. is not liable faeto follow instructions foanydamage arising system to the PD Monitor fomthe use. relating The service yeaS. life of the PDMonitodeviceis expected to be five (5) The cuentvesionof InstuctionsfoUsecoespondsto the PDMonitodeviceversion are subectto changes in future incorporated version and all revisions visit without revisions of PDMonitor prionotice.Changes of this document. will be For the latest foUseplease

/www.pdneurotechnoloqy.com. Instructions 0. 1.6. The contents of this document http:/

47 Symbol Table The symbol table contains information to locate and relocate symbolic definitions and references Manufacturer Date of manufacture Batch code handle with care Serial number Fragile,

% Temperature i The equipment Humidity Consult limits 48 limits to which the medical device can be safely exposed the instructions that accompany the PDMonitor system is suitable fodirectcurrent only To identify the positive and negative connections

(the polarity) of a DC power supply IP21 Non water resistant IP22 potected against insertion fied test in which it is exposed to vertically

(Water ingress protection) of fingesand will not be damaged obecomeunsafe during a speci or nearly vertically dripping water against splashing of water (Water ingress protection) Do not use, if package is damaged product IP24 Protected Non sterile

+ Keep dry Consult C E: 0297 Correct Class II equipment For indoor use only the instructions and precautions warnings on the medical device itself for use for important cautionary that cannot, for a variety of reasons, information, be presented such as These systems have been approved European regulatory Union's requirements to be sold as medical devices according to the Disposal of This Product (Waste Electrical

& Electronic Equipment) 49 50 pdnfbnitor APPENDIX powered by pd neurotechnology medical solutions Appendix A: EMC Information PDMonitor system Attention should be paid to the following prior EMC information to installing or using the PDMonitosystem. Portable and mobile Radio Frequency equipment may intefere with the operation

(RF) communication of the PDMonito

system. The PDMonitosystemhas been tested and found to comply with IEC/ EN 60601-1-2. Computes. cables and accessories not tested to 60601-1-2 may esultin increased emissions PDMonitosystem. odeceasedimmunity of the nomalopeation Verify stackedwith other electrical if utilizing equipment. the PDMonitosystemadacentto R emissions Class B F CISPR 11 Guidance and manufacturer's declaration

- electromagnetic emissions The PDMonitoisintended ronment spe for use in the ele c ified below. The customer or user of the PDMonitor c l h an environment. d ensure that it is used in su shou envi-

c tromag neti c Emissions Test Compliance Electromagnetic F R emissions CISPR 11 Group 1 environment PDMonitor uses RF

-guidance energy only for its internal function. Its RF emissions Therefore, are not likely to cause any interference electronic in nearby equipment. PDMonitor use in all establishments is suitab l e for c luding domestic in l and those ishments estab c c d i o te e d

, o t t h c p b li o ta g e ewe p oo,co otw ae k

th 1

'r _, l

e " c c b i d i s g se d fo d o m es ti purposes. e o c Not Harmoni c l 1ons app 1ss em able i V Fl c o l t a g e cu t u a

fli

t i n s k e r e e m i s s io s n E I C 61000-3-3 Not c able appli 52 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 ge disch a 2

-4

(ESD IEC 61000

6kVcontact 6kVcontact Floors should be wood, concrete material, be at least 3 0%

covered with synthetic 8kVair BkVair or ceramic tile. If the relative humidity should fl oors are Electrical fast transient/

burst IEC 61000-4-4 Not applicable Not applicable. cables exceed 3 m No y s Mains power qualit hould be that of a typical i spital o h environment. domestic or g Su e 0-4-

1r0 EN 6 0 5:2014+Al:2017 1 kV Pulse Voltage 1 kV Pulse Voltage ie e Vofllt a c i IEC 61000-3-3 Fluctuations/

1ons 1ss r em N/A N/A N/A y

/ 60

(50 Power frequenc Ld fi ic Hz) mainet e IEC 6 000-4-8 3A/m 3A/m of a typical Location in a typical domestic Powerequency teristic magnetic fields should be at Levels charac-

or hospital environment. 53 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. Immunity Test IEC 60601 test Level Compliance level Electromagnetic environment

-guidance Conducted EN 61000-4-6 150 kHz to 80 MHz RF 3 Vrms Radiated EN 61000-4-3 80 MHz to 2,5 GHz lOV/m RF 3V lOV/m Portable and mobile communications used no closer to any part of the PD Monitor, including cables, from calculated equipment distance should be than the recommended the equation applicable Recommended separation to the frequency separation distance of the transmitter. d = 1.2../P d = 1.2 ./P 80 MHz to 800 MHz d = 2.3..J P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmit-

ter in watts (W) according manufacturer d is the recommended Field strengths by an electromagnetic compliance occur in the vicinity to the transmitter and in metres (m). separation distance as determined site survey a) should be less than the may range. b) Interference marked with the following from fixed RF transmitters, level in each frequency of equipment I symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies NOTE 2: These guidelines objects structures, and people. may not apply in all situations. Electromagnetic propagation is affected by absorption andeflection from a)Field strengths from fixed transmitters, such as base stations telephones for radio (cellular/cordless) and land mobile radios, amateur radio, AM and FM radio broadcast due to fixed RF transmitters, the PDMonitor If abnormal is used exceeds the applicable is observed, performance additional an electromagnetic site survey should be considered. cannot be predicted theoretically with accuracy. If the measured field strength To assess the electromagnetic in the location environment in which RF compliance level above, the PDMonitor should be observed measures may be necessary, such as re-orienting or relocation to verify normal operation. the PDMonitor

. b) Over frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V /m 54 Recommended separation communications distances equipment between and the PDMonitor portable and mobile RF The PDMonitoisintended user of the PDMonitocanhelp prevent RF communications for use in the electromagnetic electromagnetic and the PDMonitor

(transmitters) equipment in which radiated environment inteferenceby maintaining as recommended equipment. communications a minimum distance RF disturbances are controlled. between portable to the maximum output poweofthe The customer and mobile or below, according transmitter 150 KHz to 80 MHz d = 1.2,/P 150 KHz to 80 MHz d = 1. P 800 MHz to 2.5 GHz d = 2.3../P Separation distance according to frequency of transmitter Rated maximum output power of w 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 10 1.2 3.8 100 12 1.2 3.8 12 2.3 7.3 23 For transmitters mated using the equation according to the transmitter manufacturer. rated at a maximum output power not Listed to the frequency of the transmitter, above, the recommended where P is the maximum output power rating of the transmitter d in metres (m) can be esti-

separation distance in watts (W) NOTE 1: At 80 MHz and 800 MHz, the sepaationdistance for the higher frequency range applies. NOTE 2: These guidelines objects structures, and people. may not apply in all situations. Electromagnetic propagation is affected by absorption from and reflection 55 Appendix B: Clinical Validation PDMonitor system performed in three sites (Geece.Italy. of two phases. in a hospital The fistphase of the study (Phase environment. a through The cuentvesionof PDMonitohasbeen validated The clinical Germany). trial study consisted I) with detailed was conducted

(video) of a wide range of symptoms monitoring. by experts. II) was conducted a home environment. validate patienVca evaluation of50subects the outcomes egive/nusediaries. fothecurentvesionof the PDMonito in Phase II were used to systemagainst used fothesymptom during of the PDMonito The dataset and assessment phase of the study (Phase ecoding The second The data acquired

(94 recording sessions). systemconsists NOTE. Theeportedaccuracy result including impovedsymptom of a new ccalvalidation analysis monitoring of the system is subectto change as a owithsoftware algorithms. updates 56 PDMonitor Performance PDMonitoOutcome Result (comparison to expert rating) Activity/Posture 0.93 Accuracy Bradykinesia Bradykinesia

+ Gait R2 = 0.46 R2 = 0.79 Wrist TemorDetection Accuacy0.89, CorelationR2 = 0.67 Leg Tremor Detection 0.93 Accuracy Gait Disturbances R2 = 0.60 Feezingof Gait 0.93 Accuracy Postural Instability 0.90 Accuracy sensitivity t y and 0.33 t y instabili in postural with 1 specifici detection Dyskinesia Presence 0.90 Accuracy Time spent with Dyskinesia R2 = 0.91 Time spent in OFF state R2 = 0.46 57 UK London Office Greece Athens Office Greece R&D unit Greece Production unit PD Neurotechnology 2 More London Riveside 89 G. Tetsetist,Neo Psychico Ethn Antistaseos PD Neuotechnology

-Kardamitsia Ethn. Antistaseos PD Neurotechnology Ltd Ltd Ltd

-Kadamitsia Ltd PD Neuotechnology 5th floor, SE12AP London, T +44 (0)20 7842 8000 suppo@pdneurotechnology.com Kingdom Athens, GR 15451, Geece T +30-2106754796 United loannina. GR 45500. Greece T + 30-2651001300, com suppo@pdneurotechnology GR 45500, Greece loannina. T +30-2651001300, support@pdneurotechnology.com F +30-2651001306 F +30-2651001306 support@pdneurotechnology.com Monitoring Devices Label OR Cede Legal Manufacturer Production Site PD Neurotechnology 5th floor, London, United Ltd. 2 MoeLondon Riveside SE 12AP Kingdom PD Neurotechnology Ltd. Ethn. Antistaseos loannina. Greece GR 45500

-Kardamitsia www.pdneurotechnology.com pdnfbnitor Standing by you, at every move you make powered by pd neurotechnology medical solutions www.pd neu rotech no logy.com

SHENZHEN LCS COMPLIANCE TESTING LABORATORY LTD. LABEL AND LOCATION PDMonitor Model No.: PDMonitor FCC ID: 2AZDG-PDMONITOR

(Size: L3.0cm x 2.5cm) Label Location Material: Tagboard Glue: adhesive sticker Font color: Blue Label color: White _____________________________________________________________________________________________________ This report shall not be reproduced except in full, without the written approval of Shenzhen LCS Compliance Testing Laboratory Ltd.. Page 1 of 1

PD Neurotechnology Ltd. Agent Authorization Company: PD Neurotechnology Ltd. Address:3rd Floor Pinners Hall, 105-108 Old Broad Street, London EC2N 1ER, United Kingdom Product Name: PDMonitor Trade Mark: PDMonitor Model Number(s):PDMonitor FCC ID: 2AZDG-PDMONITOR We authorize MiCOM Labs Inc., 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the certification of above named equipment. We declare that MiCOM Labs Inc. is allowed to forward all information related to the approval and certification of equipment to the regulatory agencies as required and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Signature:

Name:

Nikos Moschos Title:

Director Company: PD Neurotechnology Ltd. Date: 2021-06-21

PD Neurotechnology Ltd. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA Subject; Request for Confidentiality FCC ID: 2AZDG-PDMONITOR Date: 2021-06-21 To Whom It May Concern, Pursuant to the provisions of the Commissions rules Title 47 Sections 0.457 and 0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market. Schematic Diagram Block Diagram Parts List Operational Description Tune-up Procedure External Photos Test Setup Photos Internal Photos User Manual In additional to above mentioned documents, in order to comply with the marketing regulations in Title 47 CFR 2.803 and the importation rules in Title 47 CFR 2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices, we request Short Term Confidentiality of the following attachment(s);

For 45 days, pursuant to Public Notice DA 04-1705. OR For 180 days pursuant to KDB 726920 D01. It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature:

Name:Nikos Moschos Title: PD Neurotechnology Ltd.