FCC ID: 2AYZI-ECG247 Heart Monitoring Device

ECG247 Smart Sensor System Model number 353 010 Service Manual Rev. P22-02 Appsens AS Bergshaven 17 4790 Lillesand Norway https://appsens.no Appsens AS is the world leading producer of wireless ECG technology. The ECG247 Smart Sensor, combined with the ECG247 APP and a secured back-end service, can record data from the patient under a wide array of circumstances. Please refer to our website www.appsens.no for further information and news about the technology. Copyright Appsens 2020 All rights reserved. Without limiting the rights under copyrights reserved above, no part of this publication may be reproduced, stored in or introduced into a retrieval system, or transmitted, in any form or by any means (electronic, mechanical, photocopying, recording or otherwise), without the prior written permission of the copyright owner. Printed in Norway by Appsens AS. www.appsens.no ECG247 Smart Sensor System: Service Manual Page 2 of 12 Table of content 1 Scope of the service manual ........................................................................................................... 4 2 Note on FCC Part 15 statement ....................................................................................................... 4 3 4 5 6 7 8 9 ECG247 Smart Sensor System overview ....................................................................................... 4 System Components and Product Model Number ......................................................................... 4 4.1 Required Accessory ................................................................................................................. 4 Disclaimers and Warnings ............................................................................................................... 5 Declaration of conformity ............................................................................................................... 6 6.1 6.2 6.3 6.4 Conformity to standards ......................................................................................................... 6 Classification as medical device .............................................................................................. 7 Certification ............................................................................................................................. 7 Intended use ............................................................................................................................ 7 Long-term ECG Monitoring, Arrhythmia Detection and Classification ........................................... 8 ECG247 Smart Sensor identification and software versions ........................................................... 9 Equipment acceptance control ..................................................................................................... 10 10 Maintenance and periodic test ................................................................................................. 11 10.1 Expected service life .............................................................................................................. 11 11 12 13 14 Cleaning instructions ................................................................................................................. 11 Storage ...................................................................................................................................... 11 Referenced documents ............................................................................................................. 12 FCC Part 15 statement ............................................................................................................... 12 ECG247 Smart Sensor System: Service Manual Page 3 of 12 1 Scope of the service manual This service manual is intended to be used by responsible technical or biomedical engineering personnel in hospitals/clinics for having necessary control of medical equipment in use and be able of carrying out necessary technical test and maintenance. For detailed information on how to use the ECG247 Smart Sensor System please find information in the User Guide. 2 Note on FCC Part 15 statement Chapter 14 of this service manual includes a statement from the Federal Communications Commission (FCC). The referred note encapsules the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. 3 ECG247 Smart Sensor System overview The ECG247 Smart Sensor, the ECG247 APP and the ECG247 Secured cloud services are designed and manufactured by Appsens AS in Lillesand, Norway and is marketed and sold by the licensed distributors. The ECG247 Smart Sensor System is designed as a wearable arrhythmia detection solution to be easy and to feel safe to use by the patient. It is also an easy and user-friendly start-up procedure for starting a new ECG arrhythmia recording period, normally for 3-7 days. An important part of the design has been to make mobility for the patient. The user shall as far as possible be able to do the same daily activities as he/she has been used to, and also do physical training exercises still being monitored for arrhythmia events. This documentation is the reference guide for the ECG247 Smart Sensor the ECG247 APP, and the ECG247 secured back-end services provided by Appsens. 4 System Components and Product Model Number The ECG247 Smart Sensor System is defined by Product Model Number 353 010. ECG247 Smart Sensor System components consist of:

ECG247 Smart Sensor ECG247 Electrode ECG247 APP software ECG247 Web software Active Device for diagnosis intended to allow direct diagnosis or monitoring of vital physiological processes. Intended for short term use less than 30 days (re-usable) Disposable plaster patch with battery to be used with ECG247 Smart Sensor (disposable) Smartphone APP to be used with ECG247 Smart Sensor in connection with a secured back-end storage and WEB service -

Single-patient physiologic monitoring system application software in connection with a secured back-end storage service

(downloadable from AppStore and Google Play) Secured Back-end storage and analyser with WEB-service. Electrocardiographic long-term ambulatory recording analyser application software, (Cloud service with WEB-logon) GMDN 44423 GMDN 62597 GMDN 59378 GMDN 41651 4.1 Required Accessory The user will need to wear a Smartphone (Android version 8.0 or higher or iOS version 11 or higher) with Bluetooth communication and mobile data/Internet access. ECG247 Smart Sensor System: Service Manual Page 4 of 12 The user will need to have the mobile in a proximity of 10 meters during the arrhythmia investigation in order to receive detected arrhythmia episodes and for transfer of data to the secured could-based storage. To access the ECG247 WEB, a browser for PC/MAC is required (Chrome, Safari, Firefox or Edge). 5 Disclaimers and Warnings Disclaimer: Appsens AS or its partners cannot be made responsible for incorrect use of this equipment or use outside the operating norms of the equipment. All usage of the equipment that is not described in this documentation is considered incorrect use. Warning! This product is not intended for life preserving treatments. Warning! This product must only be configured according to the User Guide. Warning! To configure this product, the person must be able to read the content and give necessary input on Smartphone screen. Warning! This product requires that the user can learn how to operate the device. If there are limitations in the users learning capacity like young age, old age, mental instabilities, mental or physical handicaps then the equipment must be used under supervision by a responsible person that can assist. That can be a parent, sibling or other family member or nurse that has learned how to operate the equipment. Warning! This product must never be used with other accessories than specified in the accessory list in this document. Warning! This equipment may not be used to record the activity of an implanted pacemaker device. However, the equipment may be used by a patient with an implanted pacemaker device. Warning! This equipment may not be used during defibrillation. Warning! Do not modify this equipment without authorization from the manufacturer. Warning! Portable and mobile RF equipment e.g. mobile phones may interfere with medical equipment. Though no known problems regarding EMC has been discovered during testing, the performance of this equipment cannot be guaranteed when operated together with other RF equipment than a smartphone with installed the ECG247 APP. Warning! This equipment should not be used adjacent or stacked with other equipment, if so is necessary, both this and the stacked or adjacent medical equipment or system should be observed to verify normal operation in the configuration in which it will be used. Warning! This equipment may not be used in strong electric or magnetic fields (e.g. MR, X-ray, similar). Warning! This equipment contains an automated analysis of ECG for arrhythmia detection, and any recordings should be validated by qualified medical personnel. ECG247 Smart Sensor System: Service Manual Page 5 of 12 Warning! Do not place the ECG247 Electrode on skin sites with established erythema, lesions and injuries of any kind!

Warning! Do not use the ECG247 Electrode on users with shown irritating effects in direct electrode contact and report any incompatibility reactions observed to the distributor!

Warning! Do not use the ECG247 Electrode if the electrode hydrogel is dry!

Warning! Do not use the ECG247 Electrode for more than 14 days and do not reapply new ECG247 Electrode to the same area immediately after an examination has been ended. Warning! Do not use if the equipment is deformed or have other visible damages. Warning! This product has medical approved plaster to be applied directly on the skin. However, the user should always consider whether he/she has any allergies to medical plaster products before the product is applied. Warning! Never try to disconnect the ECG247 Smart Sensor from the disposable ECG247 Electrode during normal use. Warning! Select Stop recording in the ECG247 APP before removing the sensor with the ECG247 Electrode from the surface of the skin. Warning! The Sensor is a BF applied part and must not be brought into contact with any electrically conductive cables including electrical earth connections. Warning! The Sensor may be used during showers. However never immerse the Sensor into any fluids. Warning! This equipment is not intended used on infants below 10 kg. Warning! This equipment is not intended used for ischemia detection. Warning! Never use this equipment to diagnose unless you have the correct medical training. Warning! The ECG247 Smart Sensor may be disturbed in recording ECG-signals by static electricity, due to cloths rubbing against the sensor surface. This can especially happen during physical exercise and when using t-shirts made of Acryl or Polycarbonate. However, the disturbances will normally be reduced by humidity caused by perspiration/sweat. 6 Declaration of conformity 6.1 Conformity to standards This product is developed in conformity with the following standards:

Medical Device Directive (MDD 93/42/EEC) IEC 60601-1:2005; AMD 1:2012 IEC 60601-1-2:2014 IEC 60601-6:2010; AMD1:2013 IEC 60601-1-11:2015 IEC 60601-2-47:2012 IEC 60601-4-2:2016 IEC 60529:1989 IEC 62304:2006 ECG247 Smart Sensor System: Service Manual Page 6 of 12 IEC 62366:2015 ISO 10993-1:2009, 5:2009, 10:2010 ISO 22077-1 and ISO 22077 - 3 6.2 Classification as medical device The ECG 247 Smart sensor system is classified as: Class II a, according to Medical Device Directive

(93/42/EEC), Annex II, Chapter III, Rule 10.:

Intended for short term use <30 days Active Device for diagnosis Intended to allow direct diagnosis or monitoring of vital physiological processes 6.3 Certification The ECG247 Smart Sensor System is certified for CE-conformance, certificate No.: 10000366191-PA-

NA-NOR, valid until 27 May 2024. Biocompatibility: According to ISO 10993. Water protection: IP44 (protected against showering) Intended use 6.4 ECG247 Smart Sensor System is developed as a wearable device for diagnosis of cardiac arrhythmias

(atrial fibrillation, ventricular tachycardia, supraventricular tachycardia and pause) based on a one-

lead ECG-signal registration for 3-7 days use during normal daily activities including physical activity and training sessions, and automatic analysis for possible arrhythmia situations. The system gives possibilities for immediate visualization of actual arrhythmia findings in near-real-

time follow-up. Heart signals are unique for each individual having different shapes and sizes for different people. We cannot guarantee that the ECG247 test will detect every possible type of heart rhythm disorder for everyone. For the same reason, the automatic rhythm analysis can misinterpret the heart rhythm signals so that the system incorrectly warns of possible heart rhythm disturbance. If the test results show that you have a possible heart rhythm disorders, we recommend that you have the test results/registration assessed by a physician. ECG247 Smart Sensor is a re-usable medical device to be mounted on a disposable ECG247 Smart Sensor Patch to be sticked to the users chest, and will be wirelessly connected to a Smartphone ECG247 APP with a dedicated software and secured back-end storage service, to act as a wearable active device for indication of possible arrhythmia situations. ECG247 Smart Sensor System can be used as an automatic analysis for possible arrhythmia situations according to a color-coded condition of clinical severity as a long-term ECG monitoring procedure. The user will in the APP receive detailed instructions on how to start an arrhythmia investigation and correctly place the sensor on the chest and will at any time get notifications of possible arrhythmia events detected. ECG247 Smart Sensor is developed as a medical diagnostic tool for self-test of cardiac arrhythmias carried out by citizens without any need of a doctors prescription, or to be carried out by health care personnel. ECG247 Smart Sensor System: Service Manual Page 7 of 12 The user can from the APP or the WEB-service have an overview of the test and find information of detected arrhythmia episodes and recorded ECG-signals, and can choose to share access to this information with named persons or health care organisations, as for instance his/her local doctor for evaluation. Upon the users request, it is possible to purchase a cardiologists evaluation of the findings. Any detected arrhythmia episodes should be evaluated by a medical doctor and for decisions of preventive actions or medication. ECG247 Smart Sensor cannot be used for infants weighing less than 10 Kg. ECG247 Smart Sensor is not tested in children, and we would therefore not recommend that children take the test. ECG247 Smart Sensor cannot be used during defibrillation and should in such cases be removed. ECG247 Smart Sensor cannot be used for persons using pacemaker of internal defibrillator. ECG247 Smart Sensor is not tested on pregnant women, and we would therefore not recommend that pregnant women take the test. ECG247 Smart Sensor is not tested on persons with extreme obesity, and we would therefore not recommend the use for persons with BMI >40 (Obesity Class III). The user will need to have a Smartphone with the ECG247APP installed and be in a proximity of 10 meters to the phone in order to reliably detect and store actual arrhythmia episodes. When using the patch some skin irritation may naturally occur. Major ailments are unlikely, however if it should happen it is recommended to terminate the test and remove the patch from the skin. Damages to the skin such as skin rash will normally heal itself within few days. If the ailments persist it is recommended to contact a physician. 7 Long-term ECG Monitoring, Arrhythmia Detection and Classification Long-term ECG monitoring procedures can be recommended for persons with clinical conditions as:

o Increased risk of stroke due to AF Age >65 years Hypertension Diabetes Chronic/prior cardiovascular disease Prior TIA/stroke o Symptoms suspicious of arrhythmias Palpitations Tachycardia Bradycardia Syncope o Cardiovascular diseases with increased risk of arrhythmias o Evaluation of treatment of cardiac arrhythmias ECG247 Smart Sensor System: Service Manual Page 8 of 12 The ECG247 Smart Sensor System shall detect arrhythmias classified according to the actual clinical severity of the arrhythmia condition where the duration of the actual condition give different severities, defined as a color-coded Severity Index:

Table 1 Overview of arrhythmias detected by the ECG247 Smart Sensor System Arrhythmia Type RED conditions Orange conditions Yellow conditions Green conditions Ventricular Tachycardia Pause Heart Rate < 30 bpm

(Bradycardia) 30 sec 5 sec 30 sec

< 30 sec and > 4 beats

< 30 and 15 sec Supraventricular tachycardia 30 sec

< 30 and 15 sec

< 15 sec and > 5 sec Atrial Fibrillation Atrial Flutter Heart Rate > 180 bpm

(Tachycardia) Irregular Beat Ventricular Extrasystole Supraventricular Extrasystole 30 sec 30 sec

< 30 and 15 sec

< 15 sec and > 5 sec

< 30 and 15 sec

< 15 sec and > 5 sec 5 min

<5 min and 15 sec X X X RED = Detected arrhythmia that should be evaluated by a cardiologist ORANGE = Atrial Fibrillation arrhythmia that should be evaluated by a cardiologist YELLOW = Detected minor arrhythmia episodes that should be evaluated by a cardiologist GREEN = Normal occurrence of arrhythmia episodes Episodes of detected single Ventricular or Supraventricular beats as well as other Irregular beats are detected as Green conditions. Detected arrhythmia episodes are indicated in the ECG247 APP according to the actual color-coded conditions and will give the user a description related to the actual detections. A medical doctor needs to assess test results and verifies findings before any treatment. 8 ECG247 Smart Sensor identification and software versions When starting up a new arrhythmia investigation on a patient, the ECG247 Smart Sensor will connect to the smartphone APP. In the APP under the menu Profile, you will find information of the connected sensor with a unique Sensor-ID. In addition, you will find information of the implemented sensor Firmware version number, and version number for the ECG247 APP. ECG247 Smart Sensor System: Service Manual Page 9 of 12 When downloading the ECG247 APP, it will automatically be installed with permissions for automatic update. When starting a new investigation, the ECG247 APP will connect to the ECG247 Smart Sensor and check the installed software version number. If a newer version of the Firmware is available, the APP will instruct the user to accept downloading and installing the newer Firmware. This is recommended in order to have the latest functions and bug-fixes to be installed. 9 Equipment acceptance control When a hospital/clinic needs to carry out a system test for acceptance control, the following procedure can be used:

1. Visual check of ECG247 Smart Sensor and ECG247 Electrode a. Take a visual check of both the ECG247 Smart Sensor and the ECG247 Electrode. b. Both components are marked with a batch number, production date and for the ECG247 Electrode also the expiry date. When tearing of the protective cover underneath the ECG247 Smart Sensor, this information will be removed, and it will not be possible to track this information. 2. Mount the ECG247 Smart Sensor to the ECG247 Electrode and download the ECG247 APP on a smartphone. a. Start up a new investigation. b. In the APP menu Profile, look up the actual Sensor ID (a unique number) and the Sensor Firmware version number. c. The ECG247 Smart Sensor unique Sensor-ID may be recorded in the database of d. medical devices/ inventory register of equipment. In the ECG247 WEB service it can be possible for persons with administrative/

technical admissions to track the frequency of use for actual Sensor-IDs connected to the hospital/clinics ECG247 Cloud-service database. 3. Test and verify ECG recordings a. In order to avoid connecting the ECG247 Electrode to a patient or test-person, it can be possible to connect a suitable ECG signal phantom to the two signal pick-up electrodes of the ECG247 Electrode (see figure below). c. b. The ECG signal phantom may be configured for different types of arrhythmias, and it is thus possible to conduct a test of detected arrhythmias according to table 1. In the ECG247 APP if can be possible to have a visual inspection of the ECG recordings in real-time. The display will optimise the signal amplification in order to have best fit in the window, so it may not be possible to measure the exact signal curve deflection compared to mV/div. d. Log in to the ECG247 WEB services with appropriate user and access for selecting the actual Investigation-ID in order to observe the actual arrhythmias detected and the corresponding ECG curves. The signal amplification can be selected (10, 20 or 50 mm/mV), and the x-axes can show different resolutions (25 or 50 mm/s). The actual beat types are annotated. If any arrhythmias are detected, it is shown as the actual finding, and the annotated event is shown in the ECG curve with corresponding colour. 4. Verify the sensor identification a. Log in to the ECG247 WEB service with appropriate user and access for administrative or technical persons, to have access to the dashboard where you can select an overview of the actual Sensor-IDs belonging to the hospital/clinic. 5. If the ECG247 Smart Sensor System has implemented any integrations to the hospitals Electronic Health Record (EHR) system, it is recommended to test functionalities in the actual ECG247 Smart Sensor System: Service Manual Page 10 of 12 integration. Please refer to the actual implementation documents to see what needs to be tested and verified. a. User authentication can be integrated in a single-sign-on function in order for the doctor/nurses to be linked directly to the ECG247 WEB service with automatic authentication and authorization. b. Access to the actual patient can automatically be transferred from the EHR system, in order to display the correct patient in the ECG247 WEB service. c. Clinical report as a PDF-file can be downloaded from the ECG247 WEB service, with d. automatic import to the EHR system and connected to the correct patient. A FHIR-based Investigation Report may be exported from the ECG247 WEB service and with automatic import to the EHR system and connected to the correct patient. 10 Maintenance and periodic test Maintenance of ECG247 Smart Sensor should only be done by trained service personnel by Appsens AS. In case of maintenance, the ECG247 Smart Sensor should be returned to Appsens AS, and the user will receive a new product as replacement. It is recommended that competent technical/biomedical personnel run a random system test yearly according to the procedure described in chapter 9 Equipment acceptance control. In cases of software updates in the integration between the ECG247 Smart Sensor System and the hospital/clinics EHR system, the same test procedure should be followed to verify correct software updates. 10.1 Expected service life The ECG247 Smart Sensor has an expected service life of 5 years after purchase. Warning! Modifications or repairs are not allowed on the ECG 247 Smart Sensor or on the ECG 247 Electrode. Warning! The battery in the ECG247 Electrode should never be replaced. 11 Cleaning instructions ECG 247 Electrode is a disposable device and is not intended for reuse. The ECG247 Electrode may be cleaned during normal use with a disinfected towel, if needed. ECG 247 Smart Sensor is re-usable and may be cleaned with a disinfection towel before reuse. Warning! Never immerse any of the devices in the ECG 247 Smart Sensor System into water or any other fluids. Never try to clean the devices in water or immerse them into solvents or other fluids. Never immerse any parts of the ECG 247 Smart Sensor System into bathtubs, swimming pools or similar environments. Warning! Never use solvents other than medical/disinfection alcohol to disinfect the equipment as they may damage the plastic enclosures. 12 Storage Recommended storage conditions for ECG247 Smart Sensor and ECG247 Electrode:

Temperature: -25 -- +70 gr C Humidity: 0-90%

Pressure: 500-1060 hPa ECG247 Smart Sensor System: Service Manual Page 11 of 12 13 Referenced documents Title ECG247 Smart Sensor System User Guide ECG247 Smart Sensor System Reference Guide Doc. no Author Rev. 2.24 Appsens P2.22 Appsens No. 1 2 3 14 FCC Part 15 statement NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the Federal Communications Commission (FCC) rules. These limits are designed to provide reasonable protection against 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. If this equipment does cause harmful interference to radio or television 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:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. 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. Changes or modifications to this equipment not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. 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 interference received, including interference that may cause undesired operation. Privacy of communications may not be ensured when using this device ECG247 Smart Sensor System: Service Manual Page 12 of 12

Archive:

ECG247 Smart Sensor Label Date: 26.04-2021 Page 1 of 1 Responsible:

GTIN ECG247 Smart Sensor: 7090052220023 FCC ID: 2AYZI-ECG247 Archive:

ECG247 Smart Sensor Label Location Date: 28.04-2021 Page 1 of 1 Responsible: ER The ECG 247 Smart sensor label location is on the backside of the ECG247 Smart sensor.

Company Letter Authority to Act as Agent Date: 2021-03-04 TUV Rheinland Group 762 Park Avenue Youngsville, NC 27596 To Whom It May Concern:

I appoint TUV Rheinland (Shenzhen) Co., Ltd. to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the FCC or Industry Canadas regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by TUV Rheinland Group, still resides with Appsens AS / Bergshaven 17, 4790 Lillesand, Norway. For TCB applications, We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you, Agency Agreement Expiration Date:

12 months By

(Signature) On behalf of

Appsens AS

(Company Name) Elisabeth Ramsdal

(Print Name) Title Project Manager Telephone

+47 95 12 14 87 QF094234 Page 1 of 1 Revision 0

CONFIDENTIALITY REQUEST FOR FCC ID Confidentiality Letter Date: 2021-04-26 Subject: Confidentiality Request for FCC ID: 2AYZI-ECG247;

Pursuant to FCC 47 CRF 0.457(d) and 0.459, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent Permanent Permanent Permanent Permanent Permanent Exhibit Block Diagrams External Photos Internal Photos Operation Description/Theory of Operation Part List/Tune-Up Procedure Schematics Test Setup Photos Users Manual Appsens AS has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TUV Rheinland in the event information regarding the product or the product is made available to the public. TUV Rheinland will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-

1705. Sincerely, By:

Project Manager, Appsens AS

(Signature/Title) Elisabeth Ramsdal

(Print name)

CONFIDENTIALITY REQUEST FOR FCC ID Confidentiality Letter Date: 2021-11-26 Subject: Confidentiality Request for FCC ID: 2AYZI-ECG247;

Pursuant to FCC 47 CRF 0.457(d) and 0.459, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Permanent Permanent Permanent Permanent Permanent Permanent Exhibit Block Diagrams External Photos Internal Photos Operation Description/Theory of Operation Part List/Tune-Up Procedure Schematics Test Setup Photos Users Manual Appsens AS has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Internal photos are not enclosed in marketing material nor sales documents (including technical sales documents) to prevent them from becoming public or disclosed to unauthorized persons. Public access is restricted for products serviceable by professional designated technicians, regulated under specific agreements between Appsens AS and professional designated technicians. All sales-related interactions of the non-consumer device will be under a NDA to include third party sales and the final user of the device is subject to the NDA. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TUV Rheinland in the event information regarding the product or the product is made available to the public. TUV Rheinland will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-

1705. Sincerely, By:

Project Manager, Appsens AS

(Signature/Title) Elisabeth Ramsdal

(Print name)

(i)

(ii) NON-DISCLOSURE AND CONFIDENTIALITY AGREEMENT This non-disclosure and confidentiality agreement is entered into by:

Appsens AS, reg. no. 918 707 719, (the Disclosing Party/the Company) and Purchaser, reg.no. (the Receiving Party) Each party is hereinafter also referred to as a Party and together the Parties. 1. Background In connection with [DESCRIPTON], the Disclosing Party has made and will make information regarding, inter alia, the Company, its shareholders and affiliated companies to assist the Receiving Party to assess

[PURPOSE] (the Permitted Purpose). As a condition to such information being made available, the Receiving Party agrees to comply with the terms and conditions of this Non-Disclosure and Confidentiality Agreement (the Agreement). 2. Confidentiality Clause The Receiving Party is obligated to treat (i) the information about the Company and its past, existing or future business, affairs, the product(s) the Company aims to develop, all its intellectual property and intellectual property rights -including, but not limited to inventions, trade marks, patents, designs, copyrights, protected designs, software, source codes, algorithms, know how, technical activities and trade secrets - (all such and other intellectual property rights jointly referred to as the IPR), prospects, financial position, other assets, liabilities, operations and activities, the Companys past, existing and potential partners, customers and other business connections and the Companys past, existing and potential relations with these, and the Companys financial information, budgets, forecasts, evaluations, legal opinions, staff and management which it receives in connection with meetings, correspondence, emails and phone calls, in physical and/or virtual data rooms, and in any other way, whether orally or written, in connection with the current contact between the Parties, and (ii) the fact that the Parties

[COOPERATE/CARRY OUT NEGOTIATIONS/ETC.] and that discussions and meetings between them have been held (the Confidential Information), with the outmost confidentiality and to use it only for the Permitted Purpose. Information that is publicly available, or enters the public domain on or before the date of this Agreement or comes into the public domain subsequently other than by a breach of this Agreement, and information that has to be given to the Courts or Public Authorities or others pursuant to mandatory law, regulations or decisions made pursuant to law, shall not constitute Confidential Information. The confidentiality obligations applies to all Confidential Information received by the Receiving Partys representatives, employees, advisors, board members, and other persons that on behalf of the Receiving Party receive information (the Representatives). The Receiving Party shall only disclose Confidential Information to the Representatives on a strictly need to know basis and only for the Permitted Purpose. Further, the Receiving Party undertakes that all its Representatives who are granted access to Confidential Information or receive Confidential Information, will be made aware of the obligations stated in this Agreement and will sign a written declaration of adherence to the obligations herein prior to being granted access to any Confidential Information. The Disclosing Party may at any time request disclosure of such written declarations of adherence. The Receiving Party will be liable to, and compensate, the Disclosing Party and its shareholders, for its Representatives' violations of this Agreement as if they were a party to this Agreement. For the avoidance of doubt, This Agreement shall also apply to any and all information provided by the Disclosing Party to the Receiving Party or any of it Representatives prior to the signing of this Agreement. 3. Use of information ownership to Confidential Information and IPR The Receiving Party and its Representatives can only use Confidential Information for the Permitted Purpose. Consequently, the Receiving Party may not use the Confidential Information to the commercial, financial or competitive disadvantage of the Disclosing Party or an affiliate of the Disclosing Party (provided, that this clause shall not prevent the Receiving Party from using the Confidential Information for the Permitted Purpose). The Receiving Party recognizes and agrees that nothing in this Agreement will be construed as granting any rights, by license or otherwise to any Confidential Information of the Company disclosed pursuant to this Agreement, or to any IPR that that the Company, or its shareholders or affiliates, has held or may hold, and has issued or may issue, based on such Confidential Information. All Confidential Information

(including all copies thereof) will at all times remain the property of the Disclosing Party and will be returned to the Disclosing Party after the Receiving Partys need for it has expired, or upon request of the Disclosing Party, and in any event, upon completion or termination of this Agreement. 4. Duty of care, copying prohibition and obligation to return documentation The Receiving Party and its Representatives shall keep all Confidential Information in strict confidence, secure and protected from loss, use, disclosure, modification or access, ensuring that third parties cannot access the information. Should the Receiving Party become aware of any disclosure, modification or access that is inconsistent with this Agreement, it shall immediately notify the Disclosing Party, and do all that is in its power to prevent further inconsistencies and to mitigate the effects of the inconsistencies occurred. The Confidential Information may not be copied, photographed or duplicated in any other way without prior written consent from the Disclosing Party. The Disclosing Party may, at any time, demand the return of all written and electronic Confidential Information and possibly deletion from the Receiving Partys and the Representatives computers, storage facilities etc. 5. Liability The Receiving Party is liable for any loss that may arise due to breach of obligations according to this Agreement, including loss due to Representatives acting in defiance of this Agreement. If the Receiving Party or a Representative gains financially by breaching this Agreement, the Receiving Party must also pay the Disclosing Party an amount corresponding to the benefit gained. The Receiving Party acknowledges that monetary damages may be both incalculable and an insufficient remedy for any breach of this Agreement. Accordingly, the Receiving Party understands that in the event of any breach of this Agreement, the Disclosing Party may, in addition to monetary damages, be entitled to seek the other remedies available to it under applicable law. By signing this Agreement, the Receiving Party acknowledges and agrees that neither the Disclosing Party, its shareholders or its advisors, make any representation or give any warranty, whether express or implied, as to the accuracy, completeness, reasonableness, quality or suitability for any particular purpose of the Confidential Information, provided, however, that the foregoing shall not prohibit or limit any claim for fraud. The rights and obligations of the Parties under this Agreement shall remain in force for five years, unless replaced by another Agreement or other agreement between the Parties. The rights and obligations pursuant to clauses 5, 7 and 8 shall continue independently and survive termination. 6. Term 7. No Partnership The Parties agree that there is no partnership, joint venture, collaboration or special relationship of any kind, or intent to create one, between the Parties and that they will take no action to create, and no conduct by them should be interpreted as creating, such a relationship or intent, which must instead be separately documented by an agreement signed and approved by both Parties. 8. Governing law and dispute resolution This Agreement shall be governed by, interpreted and construed in accordance with Norwegian internal law. Any legal dispute between the Parties relating to this Agreement that cannot be resolved amicably by negotiation shall be subject to arbitration in Arendal. The proceedings and the arbitration award shall be confidential, and the Parties undertake to enter into a separate confidentiality agreement to this effect when initiating the arbitral proceedings.

[PLACE], [DATE]

[NAME]

On behalf of AppSens AS

[PLACE], [DATE]

[NAME]

On behalf of [COMPANY]