SIVA Digital Cough Monitor and Accessories Instruction Manual

Digital Cough Monitor and Accessories

Product Information:

Product Name: Digital Cough Monitor and Accessories

Version: SIVA V1.0

Compatible with: SIVA Smartphone Application V1.0 and SIVA
Wearable V1.0

Product Usage Instructions:

1. INTENDED USE

The Digital Cough Monitor and Accessories are designed to
monitor and analyze coughing patterns. It is intended for personal
use to track and manage cough symptoms.

2. SAFETY INSTRUCTIONS

2.1 COUGH MONITOR

– Ensure that the cough monitor is used only as directed.

– Keep the cough monitor away from water and other liquids.

– Do not disassemble or modify the cough monitor.

2.2 CHARGER

– Only use the provided charger to charge the cough monitor.

– Do not use the charger if it is damaged or shows signs of
overheating.

– Keep the charger away from water and other liquids.

2.3 POWER SUPPLY UNIT

– Use only the specified power supply unit for the cough
monitor.

– Do not expose the power supply unit to extreme
temperatures.

3. PRODUCT DESCRIPTION

The Digital Cough Monitor is a wearable device that tracks and
records coughing episodes. It is designed to be used in conjunction
with the SIVA Smartphone Application and SIVA Wearable.

4. PREPARATION

Before using the Digital Cough Monitor, ensure that:

– The SIVA Smartphone Application is installed and up to
date.

– The SIVA Wearable is charged and connected to the
smartphone.

5. REGULAR USE

5.1 DAILY USE OF THE SMARTPHONE

– Open the SIVA Smartphone Application and ensure it is
connected to the SIVA Wearable.

– Follow the prompts on the application to start monitoring
coughing episodes.

5.2 PUTTING THE WEARABLE COUGH MONITOR ON

– Attach the cough monitor securely to your clothing or body
using the provided clip or strap.

5.3 WEARING THE COUGH MONITOR

– Position the cough monitor in a comfortable and secure
location.

– Ensure that the cough monitor is in direct contact with your
body for accurate readings.

5.4 TAKING OFF THE COUGH MONITOR

– Gently remove the cough monitor from your clothing or
body.

– Store the cough monitor in a safe and dry place when not in
use.

Author

IFU Instructions for Use
SIVA
Function, Name Product Manager, Michael Häberli

Docu-Identifier IFU_SIVA-EN_A

Revision A

Page 1/1

Date, Signature*

Reviewer

SME for Regulatory Affairs, Alexander Duschau-Wicke

Formal Reviewer

SME for Document Control, Alexander Duschau-Wicke

Release

SME for Document Control

YYYY-MM-DD
2022-08-05

*) Signatures not necessary for draft version

History Revision A

Description of change or change identifier Initial version

Attachment: – IFU content (revision A, dated 2022-07-22)

Master for this document: TEMP_IFU-EN_A

RS-Code: RS_TEMP_IFU-EN_5-1-A

Master for this document: TEMP_IFU-EN_A

RS-Code: RS_TEMP_IFU-EN_5-1-A

Digital Cough Monitor and Accessories Instructions for Use
valid for SIVA V1.0 with SIVA Smartphone Application V1.0
and SIVA Wearable V1.0
Version: 2022-07-22

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Table of Contents

1. INTENDED USE………………………………………………………………………………………………………………………………………………………….. 4

2. SAFETY INSTRUCTIONS……………………………………………………………………………………………………………………………………………. 5

2.1

COUGH MONITOR………………………………………………………………………………………………………………………………………………………………………………………………..5

2.2

CHARGER………………………………………………………………………………………………………………………………………………………………………………………………………………..6

2.3

POWER SUPPLY UNIT………………………………………………………………………………………………………………………………………………………………………………………..7

3. PRODUCT DESCRIPTION…………………………………………………………………………………………………………………………………………. 8

4. PREPARATION…………………………………………………………………………………………………………………………………………………………. 12

5. REGULAR USE………………………………………………………………………………………………………………………………………………………….. 15

5.1

DAILY USE OF THE SMARTPHONE……………………………………………………………………………………………………………………………………………………………..15

5.2

PUTTING THE WEARABLE COUGH MONITOR ON…………………………………………………………………………………………………………………………………..15

5.3

WEARING THE COUGH MONITOR……………………………………………………………………………………………………………………………………………………………….18

5.4

TAKING OFF THE COUGH MONITOR…………………………………………………………………………………………………………………………………………………………..18

5.5

INTERACTION WITH THE SMARTPHONE APPLICATION…………………………………………………………………………………………………………………….19

5.6 CHARGING THE COUGH MONITOR (DURING BEDTIME)………………………………………………………………………………………… 22

5.7

TROUBLESHOOTING………………………………………………………………………………………………………………………………………………………………………………………..24

6. CLEANING AND MAINTENANCE…………………………………………………………………………………………………………………………… 27

6.1

CLEANING AND DISINFECTING THE COUGH MONITOR………………………………………………………………………………………………………………………..27

6.2

CLEANING THE CHARGER………………………………………………………………………………………………………………………………………………………………………………27

6.3

MAINTENANCE OF THE COUGH MONITOR AND CHARGER…………………………………………………………………………………………………………………28

7. ACCESSORIES…………………………………………………………………………………………………………………………………………………………… 29

7.1 CHARGER (INDUCTION)…………………………………………………………………………………………………………………………………….. 29

7.2

POWER SUPPLY UNIT…………………………………………………………………………………………………………………………………………………………………………………….30

8. ELECTROMAGNETIC COMPATIBILITY……………………………………………………………………………………………………………….. 31

9. TECHNICAL DATA OF THE COUGH MONITOR…………………………………………………………………………………………………… 32

10. LIST OF SYMBOLS………………………………………………………………………………………………………………………………………………. 34

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1. Intended Use
SIVA is intended to be used in adult chronic cough patients (cough that lasts eight weeks or longer) to support the diagnostic process of the treating physician and to monitor treatment progress with objective cough frequency data mapped over time.
The SIVA Wearable (cough monitor) is a small device with various sensors (sound, vibrations), which is worn around the neck on a strap at chest level during the day. During sleep, the cough monitor is placed next to the bed and simultaneously charged by a charger. The sensors thus record the cough continuously.
SIVA also includes a smartphone application in which responses to daily diary questions are collected. The application transfers data from the smartphone to a data-secure cloud.
Requirements for the use of the cough monitor:
Daily use of a smartphone with version at least iOS 13, or at least Android 10
Ability to operate simple smartphone applications Ability to correctly plug in devices to power outlets Willingness to wear cough monitor between bedtimes Willingness to store cough monitor on charger next to bed at bedtime Contraindications:
Use of other medical devices (e.g., portable oxygen concentrator, artificial pacemaker, implantable cardioverter defibrillator).
Pregnancy

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2. Safety Instructions
During the development of SIVA system, the safety requirements for medical electrical equipment according to the European standard EN 60601-1:2006+A12 and its use in a home healthcare environment according to the European standard EN 60601-111:2015 were taken into account, as well as the other applicable standards resulting from the characteristics of the system. (For information on electromagnetic compatibility, see chapter 8).
According to the risk analysis carried out during development, no unacceptable risks arise from the use of SIVA system.
Please report malfunctions, dangerous events in connection with the SIVA system or undesirable side effects occurring during use of the cough monitor or afterwards immediately to the SIVA Health service hotline.
The following residual risk exists in connection with the cough monitor:
Although the cough monitor and its accessories have been designed and tested for skin-friendliness, it is possible that users (especially those with a corresponding predisposition) react with allergic signs (skin redness, rashes, itching) to contact with the neck strap textile or the housing of the wearable cough monitor. A slight reddening that disappears after a short time is harmless. In case of severe, permanent reddening or wounds, please contact the SIVA Health service hotline.
2.1 Cough monitor
Do not drop the cough monitor as this may damage the device. Do not open the cough monitor or make any changes to the cough monitor
(breaking open, painting) as this may impair the function of the cough monitor and – if the housing is open – an unpleasant, slight electric shock may occur.
Do not operate the cough monitor in the presence of flammable anesthetics (e.g., in hospital) or other flammable substances (in signposted areas in danger of explosion, e.g., mines), as electrostatic discharges could lead to ignition sparks.
Do not operate the cough monitor in an oxygen-enriched environment (e.g., oxygen tent).
If the unit is damaged, store it out of reach of other people and pets and the SIVA Health service hotline. Collect any splintered parts of the housing to avoid the risk of small children or pets swallowing them. Do not touch the inside of the unit as this may cause an unpleasant, slight electric shock.

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2.2 Charger
The product is intended for private, non-commercial household use.
Do not put any metal materials like keys, rings, metallic phone cases etc. onto the charger
If the cough monitor is not placed correctly in the center of the charger area, it may not properly charge and or heat up more than expected. In this case, remove the cough monitor from the charger, let it cool down, and put it back to the charger, paying special attention to place it precisely in the center of the charging area.
Please use this product in the temperature range of 0-25 °C (32-77 °F), do not expose the product to water, fire, or overheated and lower temperature environments, as this may damage the product.
Keep the charger out of range of children.
Please use dry, clean, soft cloth to clean the product surface, do not use chemicals or soap.
If the charger is damaged, do not continue to operate it and contact the SIVA Health service hotline.
WARNING Do not place EC cards or similar cards with magnetic strips or magnetically sensitive objects on the product. The data on the cards may be damaged or deleted.

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2.3 Power Supply Unit
The enclosed power supply is an approved product according to the European standard for medical electrical equipment (EN 60601-1), which protects you from the risk of electric shock with mains voltage when using SIVA Wearable.
The external power supplies have high power conversion efficiency; however, they do rely on convection cooling to the surrounding environment (air) to prevent overheating or excessive internal and external surface temperatures. Therefore, there needs to be adequate access to ambient air to ensure proper thermal performance of the power supply. Do not cover the power supply with blankets, clothing, pillows, or any other poor thermal
conductor. Do not immerse the power supply in any liquid. Avoid dropping the power supply on hard surfaces. Avoid impacting the case of the power supply with any hard object. Use the proper input cord (desktop version) for the power supply. Use a proper mating connector for connection to the output of the power supply. Do not exceed the power rating of the product. If the power supply is damaged, do not continue to operate it and contact the SIVA
Health service hotline.
WARNING Do not use any power supply other than the one supplied with SIVA Wearable. The use of other mains adapters may cause overheating of the charger, undersupply of the charger, short circuits and, in the worst case, fatal electric shocks with mains voltage.

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3. Product Description
The cough monitor (SIVA Wearable) is a small device with several sensors (sound, vibrations), which is worn around the neck during the day (sensors directed against the chest) – and stored next to the bed on the charger (see below) during bedtime. If the cough monitor is charged overnight, it has sufficient energy and thus remains permanently switched on. The sensors thus record the cough continuously. A) Cough monitor (see also chapters 8 and 9) A1) Cough monitor ­ View of the top side / the side facing away from the body
Status indicator light

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A2) Cough monitor – view of the underside / the side facing the body with sensor / the side resting on the surface of the charger

Opening for sound sensor

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B) Charger (see also chapter 7.1) The charger is placed on the bedside table or next to the bed and charges the cough monitor while you sleep. B1) Charger surface (charging contact surface to the cough monitor)
B2) Charger bottom surface (contact surface to bedside table or floor)

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B3) Charger Accessories: USB Type A to USB Type C cable
C) Power supply unit (type of connector will vary based on country, see also chapter 7.2)
The power supply unit connects the charger to the mains socket or a multiple socket outlet.

D) Smartphone-Application
for iOS (at least iOS 13) for Android (at least Android 10). The procedures described in chapters 4. to Error! Reference source not found.. cover the possible interactions with SIVA Wearable as well as the incidents during your use of SIVA system.

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4. Preparation
Step 1 / Smartphone: Make sure you are connected to the internet with your smartphone. Download and install the SIVA Smartphone Application on your smartphone (unless you are using a preconfigured smartphone with the SIVA Smartphone Application already preinstalled).
Step 2 / Smartphone: Make sure that you have Bluetooth enabled on your smartphone and start the SIVA Smartphone Application. The access data will be provided by your healthcare professional (Login QR-Code).
Step 3 / Choosing a neck strap of proper length: From the selection of neck straps (small, medium, large), choose one that will place the device at a comfortable height on your chest.
Step 4 / Attaching the neck strap to the cough monitor: Push the end of the neck strap loop through the attachment loop of the cough monitor. Then move the end of the neck strap loop around device and pull it back (see sequence of pictures below).

Step 5 / Putting on the cough monitor: Attach the cough monitor around your neck as described in chapter 5.2 and wear it continuously – except when showering and swimming, in the sauna or during sporting activities where the device would disturb or hinder you – until you go to bed.

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You will receive the cough monitor fully charged at the beginning – so it has enough energy until bedtime.
NOTE To check if the cough monitor is working correctly double tap on its housing with a finger. This will enable the status indicator light for a few seconds. A blinking green light indicates that the device is active.
Step 6 / Charger & power supply (at home): Connect the charger to the enclosed power supply by with the enclosed USB cable
Connect the larger connector (USB Type A) to the power supply. Connect the the smaller connector (USB Type C) to the charger (step (2) in
illustration below).

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Step 7 (at home): Position the charger on the bedside table (or on the floor if there is no bedside table right next to the bed).
Plug the power supply unit into a wall socket or a multiple socket outlet. When the power supply is active, the LED indicator of the charger lights up green.
NOTE Only use this charger to charge the cough monitor as other chargers may not fully charge the cough monitor. Make sure that the charger is placed in an environment with a temperature of not more than 25 °C (77 °F) and avoid the charger to be placed in direct sunlight.
WARNING Do not use any power supply other than the one supplied with the SIVA system. The use of other mains adapters may cause overheating of the charger, undersupply of the charger, short circuits and, in the worst case, fatal electric shocks with mains voltage.
Step 8 (at home): Store the cough monitor on the charger while sleeping. The regular charging process is described in chapter 5.6.
Step 9 (at home): Open the SIVA smartphone application regularly every evening to respond to daily diary questions.

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5. Regular Use
5.1 Daily Use of the Smartphone
Make sure that your smartphone has access to the Internet. Make sure Bluetooth is enabled on your smartphone
5.2 Putting the wearable cough monitor on
WARNING Before hanging the cough monitor around your neck, always make sure that the
device is not damaged (cracks, missing parts). Especially if the cough monitor has been dropped on the floor. If the device is damaged, store it out of reach of other people and pets and contact the SIVA Health service hotline. Collect any splintered parts of the housing to avoid the risk of small children or pets swallowing them. Do not touch the inside of the unit, as this may cause an unpleasant, slight electric shock. If you have open wounds in the neck or chest area that could come into contact with the cough monitor or strap, do not put it on as this could lead to impaired wound healing or infection.

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Step 1: Make sure the bottom (side with label sticker) is facing the body. Step 2: Open the magnetic lock of the neck strap and close it again behind your neck Step 3: The cough monitor now lies over the garment on the chest.

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Step 4: Now push the cough monitor through the neckline of your clothing. If it feels more comfortable, you can also wear it between two layers of clothing (e.g., between vest and shirt / T-shirt and jumper).

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5.3 Wearing the Cough monitor
Wear the cough monitor during the day without interruption (except when showering and swimming, in the sauna or during sporting activities where the device would disturb or hinder you). During light sporting activities such as jogging, the cough monitor can usually be worn without any problems. If the cough monitor becomes wet with perspiration, simply clean it afterwards as described in chapter 6.1.
If you take the cough monitor off for showering, swimming, sauna or other sporting activities, always store it in a clean environment, away from high humidity and/or heat.
5.4 Taking off the Cough monitor
Step 1: Pull the cough monitor through the neckline of your clothes so that it is on top of your clothes.
Step 2: Open the magnetic lock of the neck strap and remove the cough monitor.
Step 3: Check the part of the body where the cough monitor is placed as well as the neck and throat area for skin intolerance. A slight reddening that disappears after a short time is harmless. In case of severe, permanent reddening or wounds, please contact the SIVA Health service hotline.
Step 4: Check the cough monitor and the neck strap for contamination and wetting by sweat and, if necessary, carry out cleaning as described in chapter 6.1.

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5.5 Interaction with the Smartphone Application
5.5.1 User interface elements
When you open the smartphone application while no data transmission is active, the application will provide feedback if everything is operating correctly. If there is a need for action, the screen will show corresponding information
Setting menu
Battery level indicator for cough monitor
Status feedback
Daily diary

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5.5.2 Status feedback

The status feedback indicates the overall state of the SIVA system. In case of an error, the feedback will be highlighted red to indicate the need for action. Tap on the status feedback tile to receive additional guidance how to resolve the error (see section 5.7).

The following status feedback options will occur during regular use:

Feedback

Meaning

All is well

All is well. Your data was successfully transmitted.

Searching cough monitor

The smartphone application is connecting to your cough monitor.

Communicating Uploading data Checking Wi-Fi Offboarding initiated Final data upload completed

The smartphone application is exchanging data with your cough monitor.
Your cough monitor is uploading data to the cloud. Data transmission to the cloud will occur automatically when the wearable is on the charger and has been sufficiently charged for the next day.
Your cough monitor is checking that it can access the configured Wi-Fi to upload data to the cloud.
Your cough monitoring window has ended. Please place the cough monitor on the charger and check in again tomorrow evening to verify that all remaining data has been transmitted. Your cough monitoring window has ended and the final data has been successfully transmitted. Please pack up your cough monitoring equipment and return it following the instructions you received with the equipment.

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5.5.3 Answering questions
You will be asked in the evening to confirm that you have been wearing the cough monitor on your smartphone. For this purpose, you will receive a notification message that reminds you to answer the question. The daily diary tile will indicate that answering the question is due:

Tap on the daily diary tile to answer the question:

Indication that question is due

After answering the question, tap on the arrow symbol in the upper left corner to return to the main screen.

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5.6 Charging the Cough monitor (during bedtime)
Put the cough monitor down immediately before going to bed and place it on the center of the charger that you have installed on the bedside table or next to the bed.
Contact surfaces: place the bottom of the cough on the top of the charger.
Positioning: Make sure that the cough monitor is placed flat in the center of the charger surface. When placed on the charger, the status indicator will show a green “breathing” light (i.e., slowly fading off and back on) for a few seconds to confirm that charging has started.

The indicator light will turn off after a few seconds to not be disturbing during sleep.
Leave the cough monitor on the charger for at least 6 hours so that it can fully charge.
NOTE Make sure the unit is not accessible to pets or children when charging, as they may prevent proper charging by moving the cough monitor away from the charger.

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WARNING Before charging the cough monitor, always make sure that the charger is not damaged (cracks, missing parts). Especially if the charger has fallen on the floor. If the charger is damaged, store it out of reach of other people and contact the SIVA Health service hotline. Collect any splintered parts of the housing to avoid the risk of small children or pets swallowing them.
Make sure that you only connect the charger with the enclosed USB cable and power supply, as electrical safety cannot be guaranteed with other components.

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5.7 Troubleshooting
5.7.1 Error status feedback in the smartphone application
If the status feedback shows any of the feedback options listed below, tap on the status feedback tile to receive additional guidance, e.g.:

Follow the instructions in the status screen and tap the button at the bottom of the screen to retry the action that failed previously.

Feedback

Meaning

Your data was not successfully uploaded during the last 24 hours.

No data uploaded

Before you go to sleep, please make sure to place your cough monitor on the wireless charger and be sure your Wi-Fi router is working and in range of the cough monitor when charging.
Your cough monitor was not able to access the Wi-Fi network.

No Wi-Fi access

Please check that the Wi-Fi router is powered and turned on. If you changed the Wi-Fi router, use the application’s settings menu to update Wi-Fi name and password.

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Feedback
No communication to wearable Missing permissions
Bluetooth disabled Smartphone without internet

Meaning
Your cough monitor is not responding.
Make sure the charger is plugged in. Place the cough monitor on the charger.
Some of your smartphone settings have been changed and the SIVA application is not allowed to access Bluetooth anymore.
Please make sure that the SIVA application has permissions to use Bluetooth. The retry button will take you to the smartphone settings menu.
Some of your smartphone settings have been changed and the smartphone’s Bluetooth functionality has been disabled.
Please make sure that Bluetooth is enabled in the smartphone’s settings menu.
Your smartphone does not have an Internet connection.
Please check that the Wi-Fi router is powered and turned on. If you changed the Wi-Fi router, use the smartphone’s settings menu to update Wi-Fi name and password.

System error

A system error has occurred. Terminate the smartphone application and open it again.

If the guidance provided on the status screen does not help to resolve the issue, contact the SIVA Health service hotline.

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5.7.2 Errors indicated by the cough monitor
The status indicator on the cough monitor does not light up when the cough monitor is placed on the charger.
If the green light does not come on even though the cough monitor is on the charger,
check that the charger, charging cable and plug are correctly connected to each other and to the socket.
double tap the cough monitor with your finger to enable the status indicator again ­ if the green light starts “breathing” then, charging works as intended.
and/or change the position of the cough monitor on the charger to make sure that it is oriented to fit between the guards and is
The status indicator on the cough monitor blinks red
If the status indicator blinks red instead of “breathing” green after you have placed the wearable on the charger, the current device temperature is too high to charge the battery.
Make sure that the charger is located in an environment not exceeding 25 °C (77 °F) and not placed in direct sunlight.
Remove the cough monitor from the charger, wait for a few minutes to allow it to cool down and place it on the charger again. Make sure that the cough monitor is placed in the center of the charger.
If you cannot resolve the issue, contact the SIVA Health service hotline.

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6. Cleaning and Maintenance
6.1 Cleaning and disinfecting the cough monitor
For cleaning the housing and the carrying strap: Clean the housing and the carrying strap as necessary (recommendation: at least every 2 days) with a cloth moistened with water or neutral detergent. Then rub the housing dry with a second cloth. For disinfecting the housing: If you want to disinfect the unit, wipe the housing with a cloth moistened with ethyl alcohol (75 to 90%). Then allow the housing to air dry.
WARNING Do not use thinners, petrol, cleaning agents containing chlorine and other aggressive cleaning agents for cleaning, as the housing is not resistant to these agents. This may damage the housing, resulting in an unpleasant, mild electric shock. Do not clean the unit under running water, douse it with detergent or immerse it in cleaning agents, as this could damage the unit, causing an unpleasant, mild electric shock.
6.2 Cleaning the charger
Clean the charger only with a lint-free cloth and do not use water, soap, or other cleaning agents.

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6.3 Maintenance of the cough monitor and charger
6.3.1 General remarks
Maintenance or repair must only be carried out by the manufacturer. If defective devices/connections/cables are suspected: do not use them anymore
and do not try to repair them. In this case, please contact the SIVA Health service hotline.
WARNING If a unit is damaged, store it out of reach of other people. Collect any splintered parts of the casing to avoid the risk of small children or pets swallowing them.
6.3.2 Replacement of a lost or broken cough monitor
If you contact the SIVA Health service hotline to report a broken or lost cough monitor, you will receive specific instructions how to set up your smartphone application with a replacement cough monitor.

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7. Accessories
7.1 Charger (Induction)
The ‘charger’ (mentioned in the instructions for use) is an inductive charger model BSWC-P10C manufactured by Shenzen Times Innovation Technology Co., Ltd.
Technical Data
Expected life of environmental protection: 5 years
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7.2 Power Supply Unit
The model reference of the power supply is SLE06S0599B01, manufactured by SL Power Electronics Corp.

Product features Expected life of environmental protection: 10 years

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8. Electromagnetic Compatibility
The electromagnetic compatibility of the cough monitor has been tested according to IEC 60601-1-2:2014 4th Edition (compliance with CISPR 11, Class B).
The cough monitor is suitable for operation in all environments, including the home environment.
Apart from communication with the smartphone via Bluetooth and the WiFi network for data upload to the cloud, the cough monitor uses RF energy only for its internal functions. Therefore, its RF emissions are very low and should not cause interference to electronic devices in the environment. However, the function of electronic devices that are susceptible to interference from Bluetooth or WiFi communication (frequency band 2402 – 2480 MHz) could be affected.
FCC application: 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.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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. –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.
MPE Requirements To satisfy FCC RF exposure requirements, a separation distance of 20 cm or more should be Maintained between the antenna of this device and persons during device operation. To ensure compliance, operations at closer than this distance is not recommended.

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9. Technical Data of the Cough monitor

Type Device classification (according to IEC/EN 60601-1)
Approval Degree of protection
Operating conditions Relative humidity Temperature Atmospheric pressure
Storage and transport conditions Relative humidity
Temperature Maximum enclosure temperature during operation Battery type
Expected battery life Battery operating time
Battery recharge time (in external charging station) Expected lifetime of the cough monitor Weight Dimensions (W x H x D)

Wearable digital cough monitor Type BF Applied Part Internal power supply Continuous operation Exclusively for clinical investigation IP 57 Protected from limited dust ingress. Protected from immersion between 15 centimeters and 1 meter in depth.
15% – 90% (non-condensing) 0 ­ 40 °C (32-104 °F) during wearing 0 ­ 25 °C (32-77 °F) during charging 70 kPa bis 106 kPa
0% – 90% (non-condensing) -25 ­ 70 °C 41 °C
Rechargeable Lithium-ion Polymer battery pack At least 12 months Approx. 24 hours (may be shorter if exposed to loud environments for longer periods of time during the day) 6h
At least 12 months
25 g 50 mm x 40 mm x 12.5 mm

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Data Transmission
Essential performance characteristics (according to IEC/EN 60601-1)

Frequency band 2401 ­ 2495 MHz
The cough monitor uses Bluetooth® low energy technology
Compatible with Bluetooth® 4.0 smartphones
None

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10. List of Symbols

Symbol

Meaning Degree of protection against electric shock: Type BF.

IP57

Protected from limited dust ingress. Protected from immersion between 15 centimeters and 1 meter in depth. Manufacturer
Manufacturing date

Consult instruction for use Serial number Type reference Warning Conformite Europeenne (CE marking) Name and address of the Authorized Representative Temperature limits

Humidity limits

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Do not discard electronic products as unsorted waste.

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Legal Manufacturer:
SIVA Health Ltd Zurlindenstrasse 134 CH-8003 Zurich www.siva-health.com Service Hotline: service@siva-health.com +41 44 244 80 59
Version: 2022-07-22

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Certificate Of Completion

Envelope Id: 07D458ADBA58488F818C2B0AFA56C8A4

Subject: IFU_SIVA-EN_A

Source Envelope:

Document Pages: 37

Signatures: 4

Certificate Pages: 5

Initials: 0

AutoNav: Enabled

EnvelopeId Stamping: Disabled

Time Zone: (UTC+01:00) Amsterdam, Berlin, Bern, Rome, Stockholm, Vienna

Status: Completed
Envelope Originator: Alexander Duschau-Wicke Dreikönigstrasse 34 c/o Evoleen AG Zürich, Zürich 8002 alexander.duschau-wicke@siva-health.com IP Address: 185.72.66.254

Record Tracking
Status: Original 2022-08-04 | 16:44

Holder: Alexander Duschau-Wicke

Location: DocuSign

alexander.duschau-wicke@siva-health.com

Signer Events
Michael Häberli michael.haeberli@siva-health.com CEO SIVA Health AG Security Level: Email, Account Authentication (Required)
Electronic Record and Signature Disclosure: Accepted: 2021-08-24 | 08:40 ID: e8edc2ae-b234-4103-b49c-2c71cba14838

Signature

Timestamp
Sent: 2022-08-04 | 16:46 Viewed: 2022-08-04 | 19:13 Signed: 2022-08-04 | 19:13

Signature Adoption: Uploaded Signature Image Signature ID: E8E0079C-736A-491C- BA1D-3E5F88CEBC90 Using IP Address: 178.197.227.84 Signed using mobile With Signing Authentication via DocuSign password With Signing Reasons (on each tab):
I am the author of this document

Alexander Duschau-Wicke alexander.duschau-wicke@siva-health.com CTO SIVA Health AG Security Level: Email, Account Authentication (Required)

Signature Adoption: Pre-selected Style Signature ID: 3F86F9BF-698E-4AF4-9AAF- 855AA3E512CD Using IP Address: 77.59.128.14

Sent: 2022-08-04 | 19:13 Viewed: 2022-08-05 | 08:43 Signed: 2022-08-05 | 08:43

Electronic Record and Signature Disclosure: Not Offered via DocuSign

With Signing Authentication via DocuSign password With Signing Reasons (on each tab):
I have reviewed this document

Signer Events
Alexander Duschau-Wicke
alexander.duschau-wicke@siva-health.com
CTO
SIVA Health AG
Security Level: Email, Account Authentication (Required)

Signature
Signature Adoption: Pre-selected Style Signature ID: 3F86F9BF-698E-4AF4-9AAF- 855AA3E512CD Using IP Address: 77.59.128.14

Timestamp
Sent: 2022-08-05 | 08:43 Viewed: 2022-08-05 | 08:43 Signed: 2022-08-05 | 08:43

Electronic Record and Signature Disclosure: Not Offered via DocuSign
Alexander Duschau-Wicke alexander.duschau-wicke@siva-health.com CTO SIVA Health AG Security Level: Email, Account Authentication (Required)

With Signing Authentication via DocuSign password With Signing Reasons (on each tab):
I have reviewed this document

Signature Adoption: Pre-selected Style Signature ID: 3F86F9BF-698E-4AF4-9AAF- 855AA3E512CD Using IP Address: 77.59.128.14

Sent: 2022-08-05 | 08:43 Viewed: 2022-08-05 | 08:44 Signed: 2022-08-05 | 08:44

Electronic Record and Signature Disclosure: Not Offered via DocuSign

With Signing Authentication via DocuSign password With Signing Reasons (on each tab):
I approve this document

In Person Signer Events Editor Delivery Events

Signature Status

Timestamp Timestamp

Agent Delivery Events

Status

Timestamp

Intermediary Delivery Events

Status

Timestamp

Certified Delivery Events

Status

Timestamp

Carbon Copy Events

Status

Timestamp

Witness Events

Signature

Timestamp

Notary Events

Signature

Timestamp

Envelope Summary Events
Envelope Sent Certified Delivered Signing Complete Completed

Status
Hashed/Encrypted Security Checked Security Checked Security Checked

Payment Events

Status

Electronic Record and Signature Disclosure

Timestamps
2022-08-04 | 16:46 2022-08-05 | 08:44 2022-08-05 | 08:44 2022-08-05 | 08:44
Timestamps

Electronic Record and Signature Disclosure created on: 2021-08-18 | 23:43 Parties agreed to: Michael Häberli
ELECTRONIC RECORD AND SIGNATURE DISCLOSURE
From time to time, SIVA Health AG (we, us or Company) may be required by law to provide to you certain written notices or disclosures. Described below are the terms and conditions for providing to you such notices and disclosures electronically through the DocuSign system. Please read the information below carefully and thoroughly, and if you can access this information electronically to your satisfaction and agree to this Electronic Record and Signature Disclosure (ERSD), please confirm your agreement by selecting the check-box next to I agree to use electronic records and signatures’ before clickingCONTINUE’ within the DocuSign system.
Getting paper copies
At any time, you may request from us a paper copy of any record provided or made available electronically to you by us. You will have the ability to download and print documents we send to you through the DocuSign system during and immediately after the signing session and, if you elect to create a DocuSign account, you may access the documents for a limited period of time (usually 30 days) after such documents are first sent to you. After such time, if you wish for us to send you paper copies of any such documents from our office to you, you will be charged a $0.00 per-page fee. You may request delivery of such paper copies from us by following the procedure described below.
Withdrawing your consent
If you decide to receive notices and disclosures from us electronically, you may at any time change your mind and tell us that thereafter you want to receive required notices and disclosures only in paper format. How you must inform us of your decision to receive future notices and disclosure in paper format and withdraw your consent to receive notices and disclosures electronically is described below.
Consequences of changing your mind
If you elect to receive required notices and disclosures only in paper format, it will slow the speed at which we can complete certain steps in transactions with you and delivering services to you because we will need first to send the required notices or disclosures to you in paper format, and then wait until we receive back from you your acknowledgment of your receipt of such paper notices or disclosures. Further, you will no longer be able to use the DocuSign system to receive required notices and consents electronically from us or to sign electronically documents from us.
All notices and disclosures will be sent to you electronically

Unless you tell us otherwise in accordance with the procedures described herein, we will provide electronically to you through the DocuSign system all required notices, disclosures, authorizations, acknowledgements, and other documents that are required to be provided or made available to you during the course of our relationship with you. To reduce the chance of you inadvertently not receiving any notice or disclosure, we prefer to provide all of the required notices and disclosures to you by the same method and to the same address that you have given us. Thus, you can receive all the disclosures and notices electronically or in paper format through the paper mail delivery system. If you do not agree with this process, please let us know as described below. Please also see the paragraph immediately above that describes the consequences of your electing not to receive delivery of the notices and disclosures electronically from us.
How to contact SIVA Health AG:
You may contact us to let us know of your changes as to how we may contact you electronically, to request paper copies of certain information from us, and to withdraw your prior consent to receive notices and disclosures electronically as follows: To contact us by email send messages to: alexander.duschau-wicke @siva-health.com
To advise SIVA Health AG of your new email address
To let us know of a change in your email address where we should send notices and disclosures electronically to you, you must send an email message to us at alexander.duschau-wicke@sivahealth.com and in the body of such request you must state: your previous email address, your new email address. We do not require any other information from you to change your email address.
If you created a DocuSign account, you may update it with your new email address through your account preferences.
To request paper copies from SIVA Health AG
To request delivery from us of paper copies of the notices and disclosures previously provided by us to you electronically, you must send us an email to alexander.duschau-wicke@sivahealth.com and in the body of such request you must state your email address, full name, mailing address, and telephone number. We will bill you for any fees at that time, if any.
To withdraw your consent with SIVA Health AG
To inform us that you no longer wish to receive future notices and disclosures in electronic format you may:

i. decline to sign a document from within your signing session, and on the subsequent page, select the check-box indicating you wish to withdraw your consent, or you may;
ii. send us an email to alexander.duschau-wicke@siva-health.com and in the body of such request you must state your email, full name, mailing address, and telephone number. We do not need any other information from you to withdraw consent.. The consequences of your withdrawing consent for online documents will be that transactions may take a longer time to process..
Required hardware and software
The minimum system requirements for using the DocuSign system may change over time. The current system requirements are found here: https://support.docusign.com/guides/signer-guidesigning-system-requirements.
Acknowledging your access and consent to receive and sign documents electronically
To confirm to us that you can access this information electronically, which will be similar to other electronic notices and disclosures that we will provide to you, please confirm that you have read this ERSD, and (i) that you are able to print on paper or electronically save this ERSD for your future reference and access; or (ii) that you are able to email this ERSD to an email address where you will be able to print on paper or save it for your future reference and access. Further, if you consent to receiving notices and disclosures exclusively in electronic format as described herein, then select the check-box next to I agree to use electronic records and signatures’ before clickingCONTINUE’ within the DocuSign system.
By selecting the check-box next to `I agree to use electronic records and signatures’, you confirm that:
You can access and read this Electronic Record and Signature Disclosure; and You can print on paper this Electronic Record and Signature Disclosure, or save or send
this Electronic Record and Disclosure to a location where you can print it, for future reference and access; and Until or unless you notify SIVA Health AG as described above, you consent to receive exclusively through electronic means all notices, disclosures, authorizations, acknowledgements, and other documents that are required to be provided or made available to you by SIVA Health AG during the course of your relationship with SIVA Health AG.

References

• Health: Trusted and Empathetic Health and Wellness Information
• SIVA Health | Continuous Ambulatory Cough Detection

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