FCC ID: 2AXRW0003 Medical Bracelet for Vital Signs Continuous Monitoring

EN CardioWatch 287-2 Bracelet Instruction Manual As of 2022-03-28 Revision status: 9 1 1 Table of Contents 2 3 4 5 6 INTRODUCTION ...................................................................................................................... 3 SAFETY INSTRUCTIONS ........................................................................................................... 3 3.1 Intended Use ............................................................................................................................... 3 3.2 Receiving and Inspection ............................................................................................................. 4 3.3 Data Transmission ....................................................................................................................... 5 3.4 Handling and Usage ..................................................................................................................... 5 Charger Handling and Usage ........................................................................................................ 5 3.5 3.6 Warnings ..................................................................................................................................... 6 Residual risks ............................................................................................................................... 6 3.7 3.8 Clinical benefit ............................................................................................................................. 7 Cleaning and service life............................................................................................................... 7 3.9 SYMBOLS ................................................................................................................................ 8 CONTENTS / PRODUCT INCLUDES ........................................................................................... 9 KNOW YOUR BRACELET ........................................................................................................ 10 Back and side of the bracelet ..................................................................................................... 10 Back and bottom of the bracelet ................................................................................................ 10 Charging the bracelet ................................................................................................................. 11 6.1 6.2 6.3 7.1 7.2 7.3 7 USING YOUR BRACELET WITH A SMART DEVICE .................................................................... 13 Download and install the free CORSANO app onto your smart device. .................................... 13 First time use ............................................................................................................................. 13 Pairing Your Bracelet with a Smart Device .................................................................................. 18 Pairing with the bracelet 287-1B ................................................................................................. 18 Pairing with the bracelet 287-2B ................................................................................................. 20 Troubleshooting the Bluetooth Connection ................................................................................ 24 Troubleshooting the Cloud Connection ....................................................................................... 25 7.3.1 7.3.2 7.4 7.5 8 RECORD PATIENTS ................................................................................................................ 26 9 NON-MEDICAL INFORMATION .............................................................................................. 28 10 11 12 13 14 15 16 17 ALARMS ............................................................................. Fehler! Textmarke nicht definiert. HEALTH APP AND GOOGLE FIT INTEGRATION .................................................................... 33 CLINICAL PERFORMANCE ................................................................................................... 34 SPECIFICATION .................................................................................................................. 36 ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY ........................................... 38 DISPOSAL OF THE DEVICE .................................................................................................. 42 LEGAL NOTICE FOR FCC AND ISED ...................................................................................... 43 CORSANO CONTACT INFORMATION .................................................................................. 44 As of 2022-03-28 Revision status: 9 2 2 INTRODUCTION Thank you for purchasing the Corsano CardioWatch 287-2. Corsano CardioWatch 287-2 not only analyses your heartbeat, but also your heart rhythm, oxygen saturation, respiratory rate, ECG, temperature and activity- simple and at any time. The bracelet has been validated in clinical studies and enables screening for irregular heartbeats (e.g. extrasystoles) as well as the presence of absolute arrhythmia with suspected atrial fibrillation (AF). However, irregular heartbeats (e.g. extrasystoles) and atrial fibrillation can only be diagnosed in accordance with the guidelines with an ECG of the thoracic wall, generally carried out by cardiologists. If you are feeling unwell or experience other troubling symptoms, please seek medical advice immediately. 3 SAFETY INSTRUCTIONS This instruction manual provides you with important information about the Corsano CardioWatch 287-2 Bracelet. To ensure the safe and proper use of this bracelet, READ and UNDERSTAND all of the safety and operating instructions. If you do not understand these instructions or have any questions, contact support@corsano.com before attempting to use this bracelet. For specific information about your own heartbeats, consult with your physician. 3.1 Intended Use The CardioWatch 287-2 System is intended for reusable bedside, mobile and central multi-

parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms. The CardioWatch 287-2 System is intended for temperature monitoring of the patient. The CardioWatch 287-2 System is intended for continuous monitoring of the following indices in adults:

Pulse rate Oxygen saturation Respiration rate Temperature Movement The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of:

Non-invasive blood pressure Weight ECG The CardioWatch 287-2 System is not intended for use in high-acuity environments, such as ICU or operating rooms. The CardioWatch 287-2 System is not intended for use on acutely ill cardiac patients with As of 2022-03-28 Revision status: 9 3 the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The CardioWatch 287-2 System is not a substitute for an ECG monitor. The CardioWatch 287-2 System is not intended for SpO2 monitoring in conditions of high motion or low perfusion. 3.2 Receiving and Inspection Remove this bracelet and other components from the packaging and inspect for damage. If this bracelet or any other components is damaged, DO NOT USE and contact support@corsano.com Read the Important Safety Information in this instruction manual before using this bracelet. Follow this instruction manual thoroughly for your safety. Keep for future reference. For specific information about your own heartbeats, CONSULT WITH YOUR PHYSICIAN. DO NOT use this bracelet on infants, toddlers, children or persons who cannot express themselves. DO NOT adjust medication based on readings from this bracelet. Take medication as prescribed by your physician. ONLY a physician is qualified to diagnose and treat high or irregular heartbeats. DO NOT use this bracelet on an injured arm or an arm under medical treatment. DO NOT use this bracelet in areas containing high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, computerized tomography

(CT) scanners. This may result in incorrect operation of the bracelet and/or cause an inaccurate reading. DO NOT take recordings in close vicinity to strong electromagnetic fields (e.g. electromagnetic anti-theft systems, metal detectors). DO NOT use this bracelet in oxygen rich environments or near flammable gas. The device is intended to be worn on the wrist (left or right), DO NOT use on other parts of the body. Consult with your physician before using this bracelet if you have common arrhythmias such as atrial or ventricular premature beats or atrial fibrillation; arterial sclerosis; poor perfusion; diabetes; pregnancy; pre-eclampsia or renal disease. NOTE that any of these conditions in addition to patient motion, trembling, or shivering may affect the measurement reading. NEVER diagnose or treat yourself based on your readings. ALWAYS consult with your physician. To help avoid strangulation, keep the charger cable away from infants, toddlers or children. As of 2022-03-28 Revision status: 9 4 This product contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children. The individual packaging contains important information, it should not be thrown away. 3.3 Data Transmission This product emits radio frequencies (RF) in the 2.4 GHz band. DO NOT use this product in locations where RF is restricted, such as on an aircraft or in hospitals. Turn off the Bluetooth feature in this bracelet and remove batteries and/or unplug the charger when in RF restricted areas. For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC. 3.4 Handling and Usage Stop using this bracelet and consult with your physician if you experience skin irritation or discomfort. Consult with your physician before using this bracelet on an arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of temporary interference to blood flow, which could result in injury. Consult with your physician before using this bracelet if you have severe blood flow problems or blood disorders. DO NOT use this bracelet for any purpose other than measuring heartbeats. During measurement, make sure that no mobile device or any other electrical device that emits electromagnetic fields is within 12 inches (30 cm) of this bracelet. This may result in incorrect operation of the bracelet and/or cause an inaccurate reading. DO NOT disassemble or attempt to repair this bracelet or other components. This may cause an inaccurate reading. DO NOT drop or subject this bracelet to strong shocks or vibrations. DO NOT use this bracelet with other medical electrical (ME) equipment simultaneously. This may result in incorrect operation of the bracelet and/or cause an inaccurate reading. Ensure that this bracelet has acclimated to room temperature before taking a measurement. Taking a measurement after an extreme temperature change could lead to an inaccurate reading. Ensure the bracelet is well adjusted on the wrist to have the best performance of the heart rate sensor, and not too tight to avoid skin injuries 3.5 Charger Handling and Usage USE the charger cable with a CE marked adapter with the following characteristics:

As of 2022-03-28 Revision status: 9 5 Input voltage: 100/240 V - 50hz 60hz o o Output voltage: DC 5V (+-5%) o Maximum current: 500 mA DO NOT use the charger if this bracelet or the charger cable is damaged. If this bracelet or the cable is damaged, unplug the charger immediately. Plug the charger into the appropriate USB outlet. DO NOT use in a multi-outlet plug. NEVER plug in or unplug the charger from the electric outlet with wet hands. DO NOT disassemble or attempt to repair the charger. Fully insert the USB plug at the end of the charger into the USB outlet. When unplugging the charger from the outlet, be sure to safely pull from the USB outlet. DO NOT pull from the charger cable. When handling the charger cable:

DO NOT damage it. DO NOT break it. DO NOT tamper with it. DO NOT forcibly bend or pull it. DO NOT twist it. DO NOT use it if it is gathered in a bundle. DO NOT pinch it. DO NOT place it under heavy objects. Wipe any dust off of the charger. Unplug the charger when not in use. Unplug the charger before cleaning this bracelet. 3.6 Warnings Regardless of the measurement taken using this device, you should immediately consult your practitioner when you experience symptoms that could indicate a disease, such as chest pain, pressure, tightness, etc. You may be experiencing a cardiac arrhythmia or other disease even in the absence of a notification from the APP. You should notify your practitioner at any changes of your health condition. If a serious incident occurs in relation to the device, it must be reported to the manufacturer and the competent authority. 3.7 Residual risks In rare cases, the device may detect arrhythmia while you experienced no cardiac problems. You should contact your practitioner to get a diagnostics confirmation. As of 2022-03-28 Revision status: 9 6 3.8 Clinical benefit The CardioWatch 287 provides a non-invasive and comfortable solution to continuously and accurately monitor vital signs and enables off-line analysis and screening of cardiac arrhythmia (AFib for instance) by third-party medial applications. 3.9 Cleaning and service life Use a lint-free cloth moistened with warm water to clean the housing and casing of your device. Use warm water and hypoallergenic soap to clean the strap. Dry the wrist band with a soft cloth. It is not necessary to sterilize the device. The Smartwatch is an electronic device with rechargeable battery. The expected service life is 5 years. As of 2022-03-28 Revision status: 9 7 4 SYMBOLS These instructions for use contain the following symbols (color and size may vary):

Symbol Meaning This stand-alone software is a medical device classified as risk category IIa, in accordance with rule 10 of EU Directive 93/42/EEC, last amended by 2007/47/EC of the European Parliament and Council of 5 September 2007. 1912 Indicates the medical device manufacturer Warning Indicates the need for the user to consult the instructions for use for important information such as warnings and cautions. A warning is always related to safety. Note Indicates the need for the user to consult the instructions for use Applied Part TYPE BF Applied Part (IEC 60417-5333) Indicates the manufacturer's catalogue number so the medical device can be identified Indicates the manufacturer's serial number so that a specific medical device can be identified CE marking indicates that a product complies with applicable European Union regulations FCC marking indicates the electronic device, which sold in the United States, is certified and the electromagnetic interference from the device is under the limits that are approved by Federal Communications Commission Indicates a product should not be disposed of in a landfill; the black bar indicates that the equipment was manufactured after 2005 Refer to instruction manual/booklet. The wearable device does not generate alarms. On prescription only. As of 2022-03-28 Revision status: 9 8 5 CONTENTS / PRODUCT INCLUDES Figure 1 -Bracelet (CS-287-1B) Figure 2 - Charger (CS-287CH-1) Figure 3 - Instruction Manual (CS-287IFUEN-1) NOTE: Follow instructions for use. As of 2022-03-28 Revision status: 9 9 6 KNOW YOUR BRACELET 6.1 Back and side of the bracelet

(A) Green LED

(B) Orange LED

(C) Blue LED Figure 4 Front view of Bracelet 6.2 Back and bottom of the bracelet

(D) Electrodes for ECG

(E) PPG Sensor

(F) Charge contacts

(G) Magnets for charge cable holding Figure 5 Back view of Bracelet As of 2022-03-28 Revision status: 9 10 6.3 Charging the bracelet Figure 6 Charging view Attach the charger cable to the backside of the bracelet. The magnets will pull the charger head to the bracelet. The Magnets will click the charger into position. The LED will light up to indicate that charging has started. While charging, the Bracelet will not perform any measurement. The polarity of the magnets in the bracelet and the charger will ensure that the charger contacts will align. Figure 7 Bracelet side view LED Green (A) Green (A) Green (A) Orange (B) Pattern Flashing ON OFF Flashing for 5 sec State Bracelet charging Bracelet fully charged

(when on charger) Bracelet not on charger Bracelet is initiating a As of 2022-03-28 Revision status: 9 11 Orange (B) ON for 5 seconds Blue (C) ON Bluetooth Low Energy connection Bracelet connected to a Smartphone Bracelet is performing an ECG measurement When the bracelet is close to the end of its battery autonomy, the user gets a notification through the mobile APP (20% remaining). As of 2022-03-28 Revision status: 9 12 7 USING YOUR BRACELET WITH A SMART DEVICE 7.1 Download and install the free CORSANO app onto your smart device. 7.2 First time use Select Sign Up (2) to create your account. If you have an account, select Sign In (1) 1 2 As of 2022-03-28 Revision status: 9 13 Sign Up Enter your Email Address, First Name and Last Name. Agree to Terms of Service and Privacy Policy. Press the Sign Up button As of 2022-03-28 Revision status: 9 14 You will receive an email with a link to the confirmation page. Please fill your password and confirm password. When ready, press the Continue button. As of 2022-03-28 Revision status: 9 15 A password should have at least 8 characters, at least one letter a, b, c, at least one number, and both Upper and Lower case characters. Password must NOT contain only numbers or consecutive characters As of 2022-03-28 Revision status: 9 16 After you have signed up, you can Sign-In:

As of 2022-03-28 Revision status: 9 17 7.3 Pairing Your Bracelet with a Smart Device 7.3.1 Pairing with the bracelet 287-1B Upon first sign-in, user will be asked to pair a bracelet, follow the instructions:

First, select 287-1B in the list:

As of 2022-03-28 Revision status: 9 18 Press the pusher, the orange LED will flash, the bracelet is waiting for pairing. Press on button in the app to start pairing. After button is pressed app will look for the bracelet As of 2022-03-28 Revision status: 9 19 Once the device is found, confirm by pressing on the pusher. On successful pairing, the bracelet will light the orange LED up for 10 seconds and then turn it OFF. Figure 8 APP Pairing, complete The app will display the Serial Number found. Please double check the S/N on the device and click Confirm. The devices is now paired to the app. When your bracelet is connected successfully to your smart device, the green V symbol appears under Settings:

7.3.2 Pairing with the bracelet 287-2B Upon first sign-in, user will be asked to pair a bracelet, follow the instructions:

First, select 287-2B in the list:

As of 2022-03-28 Revision status: 9 20 As of 2022-03-28 Revision status: 9 21 During the pairing phase, the user will need to put the bracelet on the charger. Press on button in the app to start pairing. After button is pressed app will look for the bracelet As of 2022-03-28 Revision status: 9 22 Once the device is found, confirm by connecting the charger. On successful pairing, the bracelet will light the orange LED up for 10 seconds and then turn it OFF. Figure 9 APP Pairing, complete The app will display the Serial Number found. Please double check the S/N on the device and click Confirm. The devices is now paired to the app. When your bracelet is connected successfully to your smart device, the green V symbol appears under Settings:

As of 2022-03-28 Revision status: 9 23 7.4 Troubleshooting the Bluetooth Connection If the connection between the bracelet and app is lost, a red X will appear:

Click on the button Please Reconnect and follow instructions:

1. Make sure your phone is nearby 2. Check if watch is charged 3. Check if GPS is on (Android only) 4. Force quit the app on your phone 5. Turn your phones Bluetooth off and on again 6. Re-open the app If these steps did not reconnect, please proceed:

1. Shut down your phone (do not do restart; completely shut the phone off and turn it back on). This will fully reset the Bluetooth system in the phone 2. Turn your phone on again 3. Re-open the app If none of the above did not resolve, you will need to re-pair your bracelet:

1. Go to watch settings: Remove/Clean old pairing 2. Go to Bluetooth settings, find 287, 286, 284 > Click Forget Device/Unpair 3. Force quit the app on your phone 4. Re-open the app 5. Press the (+) inside the watch icon in upper right corner 6. Follow pairing instructions As of 2022-03-28 Revision status: 9 24 7.5 Troubleshooting the Cloud Connection If the connection between the app and the cloud is lost, a red X will appear:

Click on the button Please Reconnect and follow instructions:

1. Make sure your phone is connected to internet 2. Force quit the app on your phone 3. Turn your phones Airplane Mode off and on again 4. Re-open the app If these steps did not reconnect, please proceed:

1. Shut down your phone (do not do restart; completely shut the phone off and turn it back on). This will fully reset your phone 2. Turn your phone on again 3. Re-open the app If none of the above did not resolve, you will need to to logout and login again to the cloud:

1. Go to profile settings and log out 2. Force quit the app on your phone 3. Re-open the app 4. Enter user and password 5. Follow instructions As of 2022-03-28 Revision status: 9 25 8 RECORD PATIENTS Click on New Patient Click on Start Measurement During the measurement, please do not remove the app from multitasking. The screen of the phone can be locked. Please keep an internet connection on the phone while measuring. Please keep the phone close to the bracelet (few meters maximum) when measuring. As of 2022-03-28 Revision status: 9 26 When you want to stop the measurement, click on Stop Measurement The app will stop the measurement. At this stagethe note is still editable. Click on Done You can start these steps again to record other patients. Confirm the stopping of the measurement by clicking on Yes:

As of 2022-03-28 Revision status: 9 27 9 NON-MEDICAL INFORMATION The CORSANO app provides non-medical information like Activity:

As of 2022-03-28 Revision status: 9 28 Sleep:

As of 2022-03-28 Revision status: 9 29 Heart Rate:

As of 2022-03-28 Revision status: 9 30 10 ALARMS IN PORTAL The CORSANO TRIALS app collects metrics from the device and synchronizes to the cloud. On the portal, the physicians can configure the limits for the different metrics and generate alarms when vital parameter measurements are outside defined conditions. For each metric, the physicians can set level of alarms:

High priority Medium priority High priority As of 2022-03-28 Revision status: 9 31 Alarms and audible signals are displayed according to the priority level:

High priority: red Medium priority: orange High priority: yellow No alarm, correct level: green As of 2022-03-28 Revision status: 9 32 11 HEALTH APP AND GOOGLE FIT INTEGRATION The CORSANO app is integrated with the Apple Health and Google Fit apps. Information about your activities and vitals helps us provide you with a monthly (premium) personal report. You have the option of turning off the integration within the Apple Health and Google Fit apps; however, doing so will limit the information available in your personal report. The CORSANO app shares the following pieces of information with the Apple Health and Google Fit app:

Heart Rate Blood pressure Height Weight The CORSANO app collects the following pieces of information from the Apple Health and Google Fit apps:

Active Energy Blood Glucose Diastolic Blood Pressure Flights Climbed Heart Rate Height Oxygen Saturation Resting Energy Sleep Analysis Steps Systolic Blood Pressure Walking + Running Distance Weight Workouts As of 2022-03-28 Revision status: 9 33 12 CLINICAL PERFORMANCE Definition Unit Range 30-220 Acquisition Time 5-10 sec Update interval 1 sec beats/minute

(bpm) Heart Rate*

RR Interval Heart Rate Variability Respiration Rate Number of beats of the heart per minute Elapsed time between two consecutive heart beats Beat to beat

(RR interval) variations Number of breaths

(inhalation -

exhalation cycles) per minute msec 300-2000 ms 5-10 sec 1 sec msec 0-200 ms 5-10 sec 1 sec breaths/minute

(brpm) 5-45 brpm 20-30 sec 1 sec Sleep Stages Detection of specific sleep stages & sleep HR awake, light sleep, deep sleep, REM sleep stage upon end of 1 min the entire sleep event Sleep Score Sleep

0-100%

10 sec 1 sec performance and sleep consistency with equal weight Functional oxygen saturation SpO2*

% saturation 70-100%

1 min 1 sec Body Temperature Temperature of the body at the measurement site Degree Celsius

*NOTES:

34-42C 30 min 1 min Accuracy *

HR is 4 bpm MAD, 5%

MARD (at rest) RR Interval 50 ms MAD, 5% MARD (at rest) HRV 10 ms MAD, 5%

MARD (at rest) Respiration Rate 1 bprm MAD, 5%

MARD (at rest) Sleep Stage 10 % MAD Sleep Score 5 % MAD 4% RMSE

(excl. motion and low perfusion)

+/- 0.3C MAD=Mean absolute difference, MARD=Mean absolute relative difference, RMSE=Root Mean Square Error Because the CardioWatch287-2 measurements are statistically distributed, only about two the measurements can be expected to fall within Arms of the value measured by a co-oximeter. thirds of SpO2 is calculated on a 30 second period and updated every second. Heart rate and SpO2 measurements cannot be considered as current data because of the synchronization delay. The synchronization usually takes less than 1 minute to the APP but may take more than 10 minutes to appear in the Cloud. Heart rate and SpO2 alarms may be delayed and are not intended for high acuity conditions like ICUs or severe pathologies. Heart rate and SpO2 are not normalized. They are measured with quality factor. When the values are potentially incorrect, they are not displayed. In this case, gaps may appear in the plots. Heart rate and SpO2 was clinically validated on adults with informed consent. Functional testers cannot be used to assess accuracy. Modified Bland Altmann plots can be provided to healthcare As of 2022-03-28 Revision status: 9 34 professional upon request. The pulse oximeter measures the pulse rate signal and computes a quality factor. When it is not able to perform a good measurement, it cannot display a heart rate value and displays a dotted line on the Heart Rate graph. The operation of the pulse oximeter can also be verified by using a simulator device (like the WhaleTeq HRS200 for example). 1. Place the CardioWatch 287-2B device on the simulator device 2. Select the simulation heart rate (70 bpm for example) 3. Read the value in the Corsano Trials APP, on the heart rate graph, LAST BPM. (The error shall be less than 1 bpm) As of 2022-03-28 Revision status: 9 35 13 SPECIFICATION Minimum requirements for mobile device Operating Systems:

iO 12.2 or higher Android 8.0 or higher PPG Sensor Characteristics*

PPG .............................................................................................. Red, IR, Green PPG LED/Photodiode number ...................................................... 7/2 PPG LEDs Peak wavelength ............................................................ 500-900 nm PPG LEDs max current ................................................................... 128 mA PPG sampling resolution ................................................................. 20 bits Radiant Intensity 525nm* ................................................................. 47mW/sr Radiant Intensity 660nm* ................................................................. 44mW/sr Radiant Intensity 880nm* ................................................................. 35mW/sr Motion Sensor Characteristics Type .............................................................................................. 3-axis Acquisition noise ............................................................................. 1.3 mg RMS Sensor range .................................................................................. 16 g full scale Data Acquisition PPG sampling rate .......................................................................... 32 Hz Motion sampling rate ....................................................................... 32 Hz Flash Memory Size ......................................................................... 256 Mbit Recording ...................................................................................... Continuous Power Requirements Average current .............................................................................. 1.2 mA Max current consumption ................................................................. 100 mA Average current .............................................................................. 1.2 Battery type .................................................................................. Rechargeable Technology ................................................................................... Lithium Polymer Battery capacity (Bracelet) ........................................................... 140 mAh Autonomy (Bracelet) ..................................................................... up to 1 week Dimensions Length x Width x Height ................................................................... 24.4 x 40.4 x 9.8 mm Environmental Specifications Ingress Protection* .......................................................................... IP66 Operational Temperature ................................................................. +10 to +40 degrees C Ambient Temperature when charging ............................................... +10 to +35 degrees C Transport and storage Temperature ................................................. -20 to +60 degrees C Operational Humidity ....................................................................... 20% to 80%

Transport and storage Humidity........................................................ 20% to 90%

Interface Wireless Communication ................................................................. BLE 5.0 Display LEDs .................................................................................. green, orange, blue As of 2022-03-28 Revision status: 9 36

*NOTES:

PPG sensor are exposed on the back of the Corsano bracelet. The PPG sensor makes contact with the users skin. IP66: Totally protected against dust. Protected against strong jets of water. Information about wavelength range can be especially useful to clinicians. As of 2022-03-28 Revision status: 9 37 14 ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY Guidance and manufacturer's declaration - electromagnetic emissions The Corsano Bracelet is intended for use in the electromagnetic environment specified below. The customer or the user of Corsano Bracelet should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations /

flicker emissions IEC 61000-3-3 Class B Class A Complies The Corsano Bracelet uses RF energy only for its internal function. Therefore, RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Corsano Bracelet is suitable for use in all establishments other than domestic and those directly connected to the public low- voltage power supply network that supplies buildings used for domestic purposes. IEC 60417-5333 TYPE BF APPLIED PART As of 2022-03-28 Revision status: 9 38 Guidance and manufacturers declarationelectromagnetic immunity Corsano racelet is intended for use in the electromagnetic environment specified below. The customer or the user of Corsano bracelet should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level 6 kV contact 8 kV air 6 kV contact 8 kV air Electromagnetic environment -

guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. 2 kV for power supply lines 1 kV for input/outpu t lines 1 kV differential mode 2 kV common mode 3 A/m 2 kV for power supply lines 1 kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. 1 kV differential mode 2 kV common mode 3 A/m Mains power quality should be that of a typical commercial or hospital environment. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Electrostatic Discharge

(ESD) IEC 61000-4-2 Electrical fast transient/burs t IEC 61000-

4-5 Surge IEC 61000-4-6 Power frequency

(50/60Hz) magnetic field IEC 61000-4-8 As of 2022-03-28 Revision status: 9 39 Guidance and manufacturers declarationelectromagnetic immunity Corsano bracelet is intended for use in the electromagnetic environment specified below. The customer or the user of Corsano bracelet should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Conducted 3 Vrms NA Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of Corsano bracelet, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance (m) d = 1.2 P Conducted RF IEC 61000-4-6 150 kHz to 80 MHz NA d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz Radiated RF IEC 61000-4-3 NA 3 V/m 80 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Corsano bracelet is used exceeds the applicable RF compliance level above, Corsano bracelet should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating Corsano Bracelet. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. As of 2022-03-28 Revision status: 9 40 Recommended separation distances between portable and mobile RF communications equipment and Corsano Bracelet Corsano Bracelet is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Corsano bracelet can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Corsano bracelet as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz d = 1.2 P 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2.5 GHz d = 2.3 P 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. As of 2022-03-28 Revision status: 9 41 15 DISPOSAL OF THE DEVICE Once your bracelet has reached its end of life it has to be properly recycled so that the material can be reused and will not end up in the environment. Preferably bring your device to a recycling service for Waste Electrical and Electronic Equipment. As of 2022-03-28 Revision status: 9 42 16 LEGAL NOTICE FOR FCC AND ISED 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 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. Connect the equipment into an outlet on a circuit different from that to which the Increase the separation between the equipment and receiver. receiver is connected. Consult the dealer or an experienced technician for help. NOTICE: This device complies with Part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s). 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. The device can be operated at a distance of 0-20 cm or higher. NOTICE: Changes or modifications made to this equipment not expressly approved by Corsano Health B.V. may void the FCC authorization to operate this equipment. NOTE: Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :

1. Lappareil ne doit pas produire de brouillage ;

2. Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. As of 2022-03-28 Revision status: 9 43 17 CORSANO CONTACT INFORMATION Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague The Netherlands www.corsano.com As of 2022-03-28 Revision status: 9 44

12/8/2021 Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595AN The Hague The Netherlands Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 To whom it may concern:

Sincerely, Signature Philippe Fraboulet CTO Corsano Health B.V. We, the undersigned, hereby authorize Eurofins Product Service GmbH to act on our behalf in all matters relating to applications for equipment authorization FCC ID: 2AXRW0003 including the signing of all documents related to these matters. effect as acts of our own. Any and all acts carried out by Eurofins Product Service GmbH on our behalf shall have the same We also hereby certify that no party to this application is subject to a denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862.

Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595AN The Hague The Netherlands Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 3/30/2022 Request for Permanent Confidentiality Company name: CORSANO HEALTH B.V. FCC ID: 2AXRW0003 FCC Part 15 Certification Gentlemen, In accordance with CFR 47 0.457 and CFR 47 0.459 Corsano Health B.V. hereby requests confidentiality of following attachments:

(1) schematic diagrams,

(2) detailed block diagrams,

(3) detailed operational descriptions,

(4) parts lists, These documents contain detailed system and equipment description and related information about the product which Corsano Health B.V. considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, Corsano Health B.V. considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Sincerely, Signature Philippe Fraboulet CTO Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595 AN The Hague, The Netherlands

Corsano Health B.V. Wilhelmina van Pruisenweg 35 2595AN The Hague The Netherlands Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 3/30/2022 Request for Short Term Confidentiality, intended to allow importation / distribution of authorized equipment while maintaining confidentiality before product launch Company name: CORSANO HEALTH B.V. FCC ID: 2AXRW0003 FCC Part 15 Certification Gentlemen, In accordance with 0.457 and 0.459 of CFR 47, CORSANO HEALTH B.V. hereby requests for Short Term Confidentiality of all External Photos, Test Setup Photos, Users Manual, Internal Photos, attachments for the subject application. These documents contain detailed system and equipment description and related information about the product which CORSANO HEALTH B.V. considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, CORSANO HEALTH B.V. considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Sincerely, Signature Philippe Fraboulet CTO Corsano Health B.V.