FCC ID: 2AAUFISPIRO1 iSpiro Ultrasonic Sensor

Instructions for Use iSpiro Ultrasonic Sensor 782200USEN Version 01.00 TABLE OF CONTENT INTRODUCTION .................................................................................................................. 5 1. 1.1. Product Description ............................................................................................................. 5 1.2. Whats in the box? .............................................................................................................. 5 Indications for Use .............................................................................................................. 6 1.3. 1.4. Restrictions, Contraindications and Possible Adverse Effects ................................................... 6 2. Operation .......................................................................................................................... 10 2.1. Operation Conditions .......................................................................................................... 10 Storage / Transport Environment .......................................................................................... 10 2.2. 2.3. Setting Up Your Device ........................................................................................................ 11 2.4. Device Indicators ................................................................................................................ 12 2.5. Turn on and off ................................................................................................................... 14 2.6. Understanding test quality .................................................................................................. 15 MAINTENANCE .................................................................................................................. 16 3. 3.1. Performance and calibration ................................................................................................ 16 3.2. Cleaning and disinfection procedure ..................................................................................... 16 3.3. Cleaning and disinfection agents .......................................................................................... 19 3.4. Cleaning the SpiroWay ........................................................................................................ 19 782200USEN_V01.00_2024-02-28 3 V01.00 - Date 28 FEB 2024 3.5. Batteries ............................................................................................................................ 20 3.5.1. Instructions for battery replacement . ................................................................................... 21 3.6. Disposal of iSpiro Ultrasonic Sensor ...................................................................................... 22 TROUBLESHOOTING ........................................................................................................... 23 4. SIGNS AND SYMBOLS ......................................................................................................... 24 5. TECHNICAL FEATURES ........................................................................................................ 25 6. 6.1. Summarized technical data .................................................................................................. 25 6.2. Device Parameters .............................................................................................................. 26 SAFETY WARNINGS AND PRECAUTIONS .............................................................................. 28 7. Notes on Safety in this Instruction Manual ............................................................................. 28 7.1. List of safety warnings and precautions ................................................................................ 29 7.2. Safety information regarding electromagnetic compatibility ................................................... 33 7.3. 7.4. IT Networks ........................................................................................................................ 34 ORDERABLE ACCESSORIES ................................................................................................. 34 8. TERMS OF WARRANTY ....................................................................................................... 35 9. ELECTROMAGNETIC COMPATIBILITY .................................................................................... 36 10. 11. BLUETOOTH WIRELESS COMMUNICATIONS .......................................................................... 42 12. FCC / IC NOTICE ................................................................................................................. 43 13. MANUFACTURER INFORMATION .......................................................................................... 45 4 1. INTRODUCTION 1.1 Product Description The iSpiro Ultrasonic Sensor is a portable spirometer that is capable of pairing via Bluetooth with smart devices to perform a spirometry test. The iSpiro Ultrasonic Sensor detects the volume and flow moving through the device to record spirometry data. The device is powered by standard 2 x AAA Alkaline batteries. The iSpiro Ultrasonic Sensor is used in combination with the SpiroWay mouthpiece. 1.2. Whats in the box?

Your iSpiro Ultrasonic Sensor box contains:

iSpiro Ultrasonic Sensor Device (b) SpiroWay (a) iSpiro Ultrasonic Sensor Cap (c) Carrying pouch (d) Instructions for use Quick-Start Guide AAA Batteries a b c d 5 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 Please check that there is no visible damage on any device components. If any damage is present, do not use or attempt to repair the device but contact the manufacturer directly. 1.3. Indications for Use The iSpiro Ultrasonic Sensor is intended to be used by adults and children over 5 years old in physicians offices, clinics and home setting to conduct basic lung function and spirometry testing. 1.4. Restrictions, Contraindications and Possible Adverse Effects Diagnosis of medical conditions or prescription of treatments can only be made by a qualified healthcare professional who may use results obtained with the iSpiro Ultrasonic Sensor 6 as adjunct information when performing a full medical examination that has taken into consideration your clinical history and other test results. The iSpiro Ultrasonic Sensor must be used by a single user at any one time. If the iSpiro Ultrasonic Sensor will be transferred to and used by a new user, it must be cleaned and disinfected according to the information given in this user manual before use. A SpiroWay mouthpiece must not be shared between users, including family members. Spirometry tests should only be performed if you are not experiencing any shortness of breath, are in good health and capable of performing a lung function test. Test results may otherwise be unreliable. Failure to perform the required breathing maneuver correctly during a test may lead to inaccurate and unacceptable results. More information about how to perform a spirometry test correctly is described in this user manual. The device should not be used if test accuracy and/or reliability is jeopardized by these or other external factors. Spirometry tests can be physically demanding. The forced expiratory maneuver used in spirometry increases intrathoracic, intraabdominal, and intracranial pressures. Potential risks of spirometry are primarily related to maximal pressures generated in the thorax and their impact on abdominal and thoracic organs, venous return and systemic blood pressure, and expansion of the chest wall and lung. The physical effort required can increase myocardial demand. Caution must be used if you have medical conditions that could be adversely affected by these physiological consequences. Although such risks are likely to be minimal for spirometry in most patients, the potential risks associated with testing should always be weighed against the benefit of obtaining information about lung function. Spirometry should be discontinued if you experience pain during the maneuver. If you have any of these potential contraindications, please seek spirometry testing in primary care settings or pulmonary function laboratories where you will be under the supervision of healthcare professionals and there may be access to emergency care if needed. 7 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 Patients aged 5 years old and over and physicians are the intended operators of the iSpiro Ultrasonic Sensor device. A competent adult should assist patients (children or older patients) who may need assistance. Relative Contraindications for Spirometry. Due to increases in myocardial demand or changes in blood pressure;

Acute myocardial infarction within 1 week Systemic hypotension or severe hypertension Significant atrial/ventricular arrhythmia Noncompensated heart failure Uncontrolled pulmonary hypertension Acute cor pulmonale Clinically unstable pulmonary embolism History of syncope related to forced expiration/cough 8 Due to increases in intracranial/intraocular pressure;

Cerebral aneurysm Brain surgery within 4 weeks Recent concussion with continuing symptoms Eye surgery within 1 week Due to increases in sinus and middle ear pressures;

Sinus surgery or middle ear surgery or infection within 1 wk If you have or suspect having any of the conditions above, consult your healthcare professional before using the iSpiro Ultrasonic Sensor. Due to increases in intrathoracic and intraabdominal pressure;

Presence of pneumothorax Thoracic surgery within 4 weeks Abdominal surgery within 4 weeks Late-term pregnancy Infection control issues;

Active or suspected transmissible respiratory or systemic infection, including tuberculosis Physical conditions predisposing to transmission of infections, such as hemoptysis, significant secretions, or oral lesions or oral bleeding 9 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 2.OPERATION Mode of Operation: There are no minimum or maximum limits to the period of device use

(on time) or disuse (off time). The device will time-out and automatically switch off if it is not actively used for a period of time. Batteries of the device should be removed if it will not be used for more than a month. 2.1. Operation Conditions The required operation conditions for the iSpiro are:

Temperature: +15C to +35C Relative Humidity: 30% to 85%

Pressure: 700 hPa to 1060 hPa The iSpiro should only be used within the ambient temperature, relative humidity and ambient pressure ranges given above. The device should remain within this range for at least 1 hour before use. 2.2. Storage / Transport Environment The required storage conditions for the iSpiro are:

Ambient temperature: -20C to +60C Relative Humidity: 5% to 85%

Pressure: 700 hPa to 1060 hPa The required transport conditions for the iSpiro Ultrasonic Sensor are:

Ambient temperature: -20C to +60C Relative Humidity: 5% to 85%

Pressure: 700 hPa to 1060 hPa The iSpiro should not be used in the presence of inflammable liquids or detergents, nor in the presence of inflammable anesthetic gases

(oxygen or nitrogen). 2.3. Setting Up Your Device ASSISTANCE: If you need assistance setting up, using or maintaining your iSpiro please contact your doctor, study investigator or Customer Care. 1 2 Remove the cap from the iSpiro Ultrasonic Sensor device. Slide open the battery cover, insert the AAA alkaline batteries in the correct orientation, slide the battery cover back to the closed position. AAA 10 11 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 3 Take the SpiroWay out of the bag. 4 Insert the SpiroWay mouthpiece into the spirometer as shown below and keep pushing until you hear a click. 2.4. Device Indicators There are 3 LED lights located on the front of the device. The LED lights may be turned on or flashing various colors in various patterns. The LED lights indicate the current status of the device. Please see the following information for guidance on LED light indications. 5 Open the device by pressing the button. LED 1 LED 2 LED 3 Table 2: Device Led Indicators LED Display Indication/s None of the LEDs are on The device is switched off LED indicators are consecutively flashing green. The device is switching on LED number 3 is constantly flashing green. The device is switched on LED number 2 is fading blue. The device is connected to the app. Bluetooth connection has been established. LED number 2 and LEDs 1 and 3 together are flashing yellow in turn. The zero flow level adjustment is in progress. LED number 1 is constantly blue. The device is ready for a test. During a test, LED number 2 is constantly flashing blue. All LEDs are flashing red. All LEDs are flashing red. The test has timed-out (there has been no inhalation/exhalation over a while) The zero flow level adjustment setup has been unsuccessful.

(Mouthpiece is removed) There is a foreign object between the sensors.

(Check device error in troubleshooting section) LEDs are consecutively flashing yellow. Over-the-air connection is being established. LED number 3 flashes red three times. Battery low warning. LEDs flash in reverse order and remain switched off. The device is switching off. 12 13 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 2.5. Turn on and off 1 3 To connect the iSpiro Ultrasonic Sensor with your device press the power key button on the iSpiro Ultrasonic Sensor. After completing your spirometry session, switch off the device by pressing the power key. Use the cap to protect the mouthpiece from contamination when the device is not in use. 2.6. How to perform a Lung function test For instructions on how to perform the maneuver, please see the related Instructions for Use of the mobile application. Lung function test should be conducted according to ATS standards (see Graham B, Steenbruggen I, Miller M, et al. Standardization of spirometry 2019 update. An official American Thoracic Society and European Respiratory Society technical statement. Am J Respir Crit Care Med. 2019; 200:e70-e88). 2 Before starting a spirometry test with a patient, ensure that the spirometer is connected to the smart device. 14 15 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 3.MAINTENANCE Handle the iSpiro Ultrasonic Sensor and SpiroWay mouthpiece with care. Do not use the device or its accessories if they are visibly damaged, particularly if there is damage to the filters on the mouthpiece or deformation of the mouthpiece itself. Store the iSpiro Ultrasonic Sensor and SpiroWay in dust-, dirt-, and moisture-free conditions. Before each use, always check that the device is free from contaminants and does not have any visible damage. 3.1 Performance and calibration The iSpiro Ultrasonic Sensor is provided to the user factory-calibrated and does not require routine re-

calibration. If you suspect performance errors in the iSpiro Ultrasonic Sensor, cease use of the device and test your lung function in a clinical setting to verify the results . Devices with confirmed performance errors should be returned to Clario. 3.2 Cleaning and disinfection procedure You should clean the iSpiro Ultrasonic Sensor body and cap at least once a week or whenever the device is visibly contaminated. You MUST perform the cleaning step before performing the disinfection step. Cleaning will prevent the physical buildup of contaminants on device surfaces and remove larger debris. Disinfection kills and destroys pathogens such as bacteria, viruses, or other microorganisms which might still be present on device surfaces after initial cleaning. 1 2 Wash Hands Before beginning the procedure, wash hands thoroughly with soap and water. Perform Cleaning First, remove the SpiroWay from the iSpiro Ultrasonic Sensor device. Using a disinfectant wipe, wipe all accessible surfaces of the device and cap using moderate pressure (as shown) for at least 30 seconds to remove contaminants. Be gentle and use care when wiping the sensors to avoid damaging them. 16 17 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 Prevent any excess liquids contained within the wipes from entering the components of the iSpiro Ultrasonic Sensor. Never immerse the product in water or any other liquid solution. 3 4 Perform disinfection To disinfect the device and cap use a fresh disinfectant wipe to wipe over all accessible surfaces again using moderate pressure and for the contact time recommended by the wipe manufacturer. Wash Hands Wash hands thoroughly after performing a cleaning or disinfection procedure, and before handling the cleaned or disinfected components again for packing and storage. 3.3. Cleaning and disinfection agents The following cleaning/disinfectant agent/s may be used to clean and disinfect this device:

CaviWipes disinfecting towelettes (Active ingredients: Isopropanol (17.2%) and Ammomium Chloride), which can be purchased at:

3.4. Cleaning the SpiroWay To clean the SpiroWay Mouthpiece once a week and whenever visibly soiled;

Add dishwashing detergent (e.g. those containing 5-15% anionic surfactant, 5% nonionic surfactant) to warm water to create a soapy solution. Shake the mouthpiece gently in the soapy solution. Hold the mouthpiece under running tap water to rinse, do not rub Leave the mouthpiece upright on a clean lint-free cloth at room temperature until it is completely dry Do not insert the SpiroWay mouthpiece into your iSpiro Ultrasonic Sensor device until it is completely dry The SpiroWay should be replaced every 3 months. The SpiroWay mouthpiece must be replaced and the device thoroughly disinfected if user has used the mouthpiece whilst having or suspected of having a dangerous infectious disease. 18 19 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 The SpiroWay must be replaced immediately if the filters are damaged or whenever a risk of contamination is suspected. Risk of Cross-Contamination The SpiroWay mouthpiece is indicated for single-patient-use only to prevent any potential of cross-contamination. Thorough cleaning and disinfection of the iSpiro Ultrasonic Sensor device must be performed prior to the dedication of the iSpiro Ultrasonic Sensor device to a new user. A new mouthpiece must be used by the new user. 3.5. Batteries The iSpiro Ultrasonic Sensor device operates with 1.5V AAA Alkaline batteries. The battery life of the iSpiro Ultrasonic Sensor is approximately 12-18 months, assuming daily use of the device. The battery charge level is continuously monitored by the device. The device will not turn on if the battery charge level is low and will make a beeping sound to notify you. The batteries of the device should be removed if the device is not going to be used for more than a month. 3.5.1. Instructions for battery replacement 1 Remove cap and SpiroWay mouthpiece from the device. 2 Slide battery cover to open position. 4 Insert new batteries in the correct orientation. 3 Remove the empty batteries. 5 Slide the battery cover back to the closed position. 20 21 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 6 7 Insert the SpiroWay in the right orientation. Your device is now ready to use. Place cap on device to protect mouthpiece from contamination during storage. 3.6. Disposal of iSpiro Ultrasonic Sensor This product is not to be discarded as regular household waste but should be discarded as electronic waste in accordance with local regulations and returned to a collection point of recycling for electric and electronic devices. Used batteries should be disposed of in designated battery recycling containers in accordance with local laws and regulations. 4. TROUBLESHOOTING Problem Cause Solution Device not turning on Multiple possible causes The smart device is out of range Smart device Bluetooth is disabled Bluetooth connection not working properly SpiroWay mouthpiece is dirty SpiroWay mouthpiece is damaged SpiroWay mouthpiece is installed incorrectly Direct air flow through on the iSpiro Ultrasonic Sensor device iSpiro Ultrasonic Sensor cannot connect to a smart device via Bluetooth Test results are inconsistent The test does not start -

Cannot set up zero flow level adjustment Test starts before you start blowing Device disconnected during test Check battery orientation and correct polarities Remove the AAA batteries, wait 30 seconds and reinstall AAA batteries Replace AAA batteries Check that battery cap is in the lock position, or if the cap is broken, contact manufacturer Bring your smart device closer to the iSpiro device Enable Bluetooth on your smart device Your smart device will need Bluetooth version 4.0 or higher. Find and select iSpiro Ultrasonic Sensor from the list of detected devices. Clean SpiroWay to ensure that the lumen is not obstructed or replace with a new mouthpiece Replace SpiroWay Refer to the user manual for proper installation of SpiroWay Close the cap of the iSpiro Ultrasonic Sensor to avoid effects of environmental flow Place the device on a flat surface Remove causes of direct air flow e.g. air conditioner, opened window, fan, etc. Rough handling of the device Keep the device as stable as possible after starting a test The device is turned off accidentally or due to rough handling during use Bluetooth connection disrupted Switch the device on again and proceed with a new test Reconnect the device and proceed with a new test 22 23 For any other technical queries please call Clarios Customer Care. V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 5. SIGNS AND SYMBOLS The following signs and symbols provided for the safe use and storage of your iSpiro Ultrasonic Sensor SYMBOL EXPLANATORY TEXT SYMBOL EXPLANATORY TEXT Indicates the medical device manufacturer Date when the medical device was manufac-

tured Manufacturers catalog/reference number for the device Manufacturers serial number Manufacturers batch/lot code Device should not be used if the package has been damaged or opened and user should consult the instructions for use for additional information Device that needs protection from light sources Device that needs protection from moisture Keep dry, keep away from rain Indicates the temperature limits to which the medical device can be safely exposed Indicates the range of humidity ot which the medical device can be safely exposed Indicates acceptable upper and lower limits of atmospheric pressure for transport and storage. Device that may be used multiple times (multiple procedures) on a single patient Attention!

Applied part of Type BF Instruction manual/booklet must be read IP22: N1=2, Protected against solid foreign objects of 12,5 mm and greater; N2=2, Protection against vertically falling water drops when ENCLOSURE tilted up to 15 Possible source of interference 24 SYMBOL EXPLANATORY TEXT Separate collection for waste of electrical and electronic equipment. Do not dispose of battery in municipal waste. Packaging is recyclable. CAUTION: FEDERAL U.S. LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. On battery powered equipment 0123 CE sign with code number of the Notified Body. The certified quality management system of eResearchTechnology GmbH corresponds to the international standard of ISO 13485. Meets FCC requirements per 47 CFR Part 15 Sensor unit FCC ID: 2AAUFISPIRO1 IC ICC Identification Number Sensor Unit IC ID: 11335A-ISPIRO1 Presents hazards in all MR environments. MD UDI Medical Device Unique Device Identifier 6. TECHNICAL FEATURES 6.1.Summarized technical data Flow / Volume Measurement Method Power Supply Dimensions Weight (With batteries) Weight (Without batteries) Flow range Maximum volume measured Volume accuracy (Average) Flow Accuracy (Average) Highest Expiratory Impedance*

Volume resolution Flow resolution Medical device class Wireless connection Ultrasonic pulse transit-time measurement 2 x 1.5V AAA Alkaline or rechargeable batteries 110 x 63 x 41 mm 90 g 67 g 0 - 14 L/s 10 L 2.50 % or 0.05 L 10.00 % or 170 mL/s 48.54 Pa*s/L 1 mL 1 mL/s Class IIa BLE 4.2

*Tested according to ISO26782 Annex B 25 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 6.2. Device Parameters The iSpiro Ultrasonic Sensor records the following spirometry data:

Parameters Definition Forced Vital Capacity The volume of air that can forcibly be blown out after full inspiration Forced Expiratory Volume within 0.75 seconds: The volume of air that can forcibly be blown out within 0.75 seconds, after full inspiration. Forced Expiratory Volume within 1 second Forced Expiratory Volume within 3 seconds Forced Expiratory Volume within 6 seconds The ratio of FEV0.75 to FVC The ratio of FEV1 to FVC The ratio of FEV3 to FVC The ratio of FEV6 to FVC Peak Expiratory Flow The maximal flow rate achieved during the maximally forced expiration initiated at full inspiration. Mean Mid-Expiratory Flow synonymous with FEF25-75 Forced Expiratory Flow at 25% of vital capacity synonymous with MEF75 Forced Expiratory Flow at 50% of vital capacity synonymous with MEF50 Forced Expiratory Flow at 75% of vital capacity synonymous with MEF25 Forced Expiratory Flow from 25% to 75% of vital capacity synonymous with MMEF Mid-Expiratory Time synonymous with FET25-75 The ratio of FEV0.75 to FEV6 FVC FEV0.75 FEV1 FEV3 FEV6 FEV0.75/FVC FEV1/FVC FEV3/FVC FEV6/FVC PEF MMEF FEF25 FEF50 FEF75 FEF25-75 MET25-75 FEV0.75/FEV6 26 Unit L L L L L

L/s L/s L/s L/s L/s L/s s

Parameters FEV1/FEV6 FEF50/FVC MMEF/FVC FET BEV FIV1 FIVC PIF FIF25-75 FIV1/FIVC R50

(FEF50/FIF50) VC VCin VCex ERV IRV IC Rf VT MVV MVV6 MVVtime Definition The ratio of FEV1 to FEV6 The ratio of FEF50 to FVC The ratio of MMEF to FVC Forced Expiratory Time Back extrapolated volume The forced inspiratory volume within 1 second Forced inspiratory vital capacity Peak inspiratory flow Forced inspiratory flow at 25% of vital capacity synonymous with MIF75 The ratio of FIV1 to FIVC The ratio of flow at 50% of expiration and flow at 50% of inspiration synonymous with FEF50/FIF50 Vital capacity, from slow expiration Inspiratory vital capacity, from slow inspiration Expiratory vital capacity, from slow expiration Expiratory reserve volume Inspiratory reserve volume Inspiratory capacity from end of tidal breathing Respiratory frequency Tidal Volume Maximum voluntary ventilation Maximum plat voluntary ventilation for 6 seconds Duration of the trial in seconds Unit

1/s 1/s s L L L L/s L/s

L L L L L L 1/min L L/min L/min s 27 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 7. SAFETY WARNINGS AND PRECAUTIONS 7.2 List of safety warnings and precautions 7.1.Notes on Safety in this Instruction Manual Following the ANSI (American National Standards Institute) recommendations for safety notes, specific passages of this instruction manual are clearly marked as safety notes. Degree of Danger Injury to persons Damages to property Meaning of Indicator X X X DANGER indicates an immediate hazardous situation, which, if not avoided, will result in serious injury or death. Limited to extremely dangerous situations. WARNING indicates a potential hazardous situation, which, if not avoided, may result in serious injury or death.

(X) Caution indicates a potential hazardous situation, which, if not avoided, may result in minor or slight injury. Also used to indicate precarious procedures. Additional safety symbols used in this user manual. General Warning Sign General mandatory action sign Special warning should be given by handlers of the device to elderly, pediatric or differently-abled users prior to use of the device. Do not use this device for any other purpose than its intended use to avoid potential dangers or harm to users. This device is not recommended for children under the age of 5. If any damage is present on the device or its components upon initial unboxing of the product then do not use the device as this may affect device performance and return it to the supplier. Take care when inserting the mouthpiece into the device to avoid physical injury and/or damage to the device. Do not use this device or its accessories if any parts are damaged, detached or blocked to avoid risk of choking or asphyxiation during use. In case of adverse events related to device use, immediately cease further use to avoid harm or damage and notify relevant local authorities and the manufacturer. Maximal inflation is unnatural; you may not have achieved it before, and it may seem somewhat uncomfortable. 28 29 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 Do not use the device in the presence of direct air currents (e.g. wind), sources of heat or cold, direct sun rays, or other sources of light or energy (such as heaters or radiators), dust, sand, or any other chemical substances as these conditions can affect the performance or the expected life of the iSpiro Ultrasonic Sensor device. If your device is damaged or malfunctioning, contact the manufacturer or distributor if purchased from a reseller. Unauthorized repairs will terminate the product warranty and may result in a faulty device. Follow all data security warnings and recommendations for your personal smart device as per its manufacturers instructions to protect your personal data. Do not share your iSpiro Ultrasonic Sensor account information with unauthorized parties. This will help protect your personal data. iSpiro Ultrasonic Sensor devices may be affected by electromagnetic interference. Please read EMC information and precautions provided in this user manual before use. Do not use iSpiro Ultrasonic Sensor devices in the presence of external portable and mobile radio frequency (RF) communications equipment as this may affect data transmission. Keep your iSpiro Ultrasonic Sensor device away from strong sources of magnetic and RF fields such as large electric motors, amateur radio transmitters, radar, anti-theft systems, stereo speakers, cell phones, and radio frequency identification (RFID). Television and radio transmitters could cause interference if the device is used close to them. Federal Law (USA) restricts this device to sale by or on the order of a physician. 7.3.Safety information regarding electromagnetic compatibility The iSpiro Ultrasonic Sensor should not be operated at the same time as electrical devices with a high RF power output (e.g. HF surgical equipment) during intended use. The iSpiro Ultrasonic Sensor may be affected by portable wireless communications equipment such as antennas, wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-

talkies, etc. A minimum distance of 30 cm (12 inches) should be kept between these and any part of the iSpiro Ultrasonic Sensor. Use of accessories or components (e.g transducers) other than those specified by the manufacturer may result in increased emissions or decreased immunity of the iSpiro Ultrasonic Sensor. The iSpiro Ultrasonic Sensor should not be used adjacent to or stacked with other equipment. If this is unavoidable the configuration in which it is used should be monitored closely to ensure that the device continues to function normally. If there are electromagnetic fields from other electrical devices nearby whilst the iSpiro Ultrasonic Sensor is being used, the device may fail to respond or not function as normal. To restart the iSpiro Ultrasonic Sensor, turn the device off and on again. If the problem persists, move the device away from sources of electromagnetic interference as described in the EMC compatibility section of this user manual. 32 33 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 7.4.IT Networks Connection of the mobile application to an IT network that includes other equipment could result in previously unidentified risks to patients, operators, or third parties. Subsequent changes to the IT network could introduce new risks and require additional analysis. Changes to the IT network include:

changes in the IT network configuration, connection of additional items to the IT network, disconnecting items from the IT network, update of equipment connected to the IT network, and upgrade of equipment connected to the IT network. 34 It is the users responsibility to identify, analyze, evaluate, and control these risks. IEC 80001-1:2021 provides guidance to address these risks. 8.ORDERABLE ACCESSORIES SpiroWay 4-Pack

(Ref number: 892115) iSpiro Ultrasonic Sensor Cap

(Ref number: 707014) iSpiro Ultrasonic Sensor Pouch

(Ref number: 707013) 9. TERMS OF WARRANTY The SpiroWay Mouthpiece is the applied part of the iSpiro Ultrasonic Sensor device. To purchase these accessories please contact your local distributors or Clario. The iSpiro Ultrasonic Sensor hardware is guaranteed against manufacturing defects for a period of 24 months effective from the date of purchase, upon the provision of an invoice or sales receipt. The service life of the iSpiro Ultrasonic Sensor (includes spirometer, cap and carry pouch) and is 5 years from purchase. The service life of the Spiroway mouthpiece is 3 months from first use. There are no user serviceable parts in the iSpiro Ultrasonic Sensor product. The customer must return goods for replacement or repair at the customers expense to the authorized supplier or manufacturer. The product must be returned with a clear written explanation of the fault or problem. This warranty does not apply, at the discretion of the manufacturer, in the following cases:

Improper installation or operation of the device Use of the product for purposes other than those specified in this user manual Damage due to failure to follow instructions Damage due to unauthorized repair, modification or reconfiguration performed on the device 35 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 Damage caused by falls, hit, lack of proper care or maintenance Damage caused by abnormal physical or electrical stress or defects of the electric supply

(battery cell) or of equipments If the serial number is altered, deleted, removed or rendered illegible In any case, the entire liability of nofab Salk Teknolojileri A.. under the provision of this agreement shall be limited to the amount paid by the customer for the product. 10. ELECTROMAGNETIC COMPATIBILITY Meeting the requirements for EMC

(electromagnetic compatibility) and preventing the unsafe use of the device, medical devices including the iSpiro Ultrasonic Sensor manufactured by Clario conform to the EN60601-1-2 standard which defines the levels of immunity to electromagnetic interference as well as maximum levels of electromagnetic emissions for medical devices. For details, please see the following tables:

Table 1: Emission table for IEC 60601-1-2 Guidance and manufacturers declaration electromagnetic emissions iSpiro Ultrasonic Sensor battery-operated spirometer devices are intended for use in the electromagnetic environments specified below. Users of these devices should assure that it is used in such environments. Emission Test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 iSpiro Ultrasonic Sensor uses RF energy for its internal function. Its Radio Bluetooth, BLE module also complies with the national regulations. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. However, a separation distance of 30 cm shall be maintained. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Not applicable The iSpiro Ultrasonic Sensor devices are suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations / flicker emissions IEC 61000-3-3 Not applicable Emissions are not applicable because iSpiro Ultrasonic Sensor does not connect to mains supply but operates with AAA batteries. 36 37 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 Table 2: Immunity (Stimulation mode) table according to IEC 60601-1-2 Guidance and manufacturers declaration electromagnetic immunity iSpiro Ultrasonic Sensor battery-operated spirometer devices are intended for use in the electromagnetic environment specified below. Users of these devices should assure that it is used in such an environment. Immunity Test Standard IEC 60601 test level Compliance level Recommended separation distance Electrostatic discharge (ESD) IEC 61000-4-2 8 kV contact 2, 4, 8 kV, 15 kV Air 8 kV contact 2, 4, 8 kV, 15 kV Air Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Radiated RF IEC 61000-4-3 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical domestic, commercial or hospital environment. Guidance and manufacturers declaration electromagnetic immunity iSpiro Ultrasonic Sensor battery-operated spirometer devices are intended for use in the electromagnetic environment specified below. Users of these devices should assure that it is used in such an environment. Immunity Test Standard IEC 60601 test level Compliance level Recommended separation distance 385 MHz 27 V/m 450 MHz 28 V/m 710, 745, 780 MHz 9 V/m 810, 870, 930, 1720, 1845, 1970, 2450 MHz 28 V/m 5240, 5500, 5785 MHz 9 V/m 27 V/m 28 V/m 9 V/m 28 V/m 9 V/m 80 MHz to 2.7 GHz 10 V/m 10 V/m Portable and mobile RF communications equipment should be used no closer to any part of the iSpiro Ultrasonic Sensor devices including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Recommend separation distance d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.7 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:

38 39 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a Field strength from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile 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 the iSpiro Ultrasonic Sensor devices are used exceeds the applicable RF compliance level above, the iSpiro Ultrasonic Sensor device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the iSpiro Ultrasonic Sensor device. b Over the frequency range 150 kHz to 80MHz, field strengths should be less than 10 V/m. Recommended separation distances between portable and mobile RF communications equipment. iSpiro Ultrasonic Sensor devices are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Users of iSpiro Ultrasonic Sensor devices can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the iSpiro Ultrasonic Sensor device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter 80 MHz - 800 MHz d = 0.35 P 800 MHz - 2500 MHz d = 0.7 P 0.01 W 0.1 W 1 W 10 W 100 W 0.035 m 0.11 m 0.35 m 1.11 m 3.5 m 0.07 m 0.22 m 0.7 m 2.21 m 7 m For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated 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: At 80MHz and 800MHz, the separation distance for the higher frequency range applies Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 40 41 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 11. BLUETOOTH WIRELESS COMMUNICATIONS Bluetooth is used to pair the iSpiro Ultrasonic Sensor with smart devices and transfer test data between them. Bluetooth data transfer involves the widely trusted use of pre-shared key authentication and encryption algorithms. The strength of Bluetooth security depends heavily on the length and randomness of the passkey used for Bluetooth pairing. Initial pairing involves mutual authentication between devices where a link key is set up between them for later authentication and encryption. Encryption of data sent between devices prevents unintended or malicious interference. Each iSpiro Ultrasonic Sensor will connect to the smart device it is paired with and will not be confused with other Bluetooth radio communications. Frequency Band:

Transmission Frequency Range:

Max Output Power:

Antenna gain:

2400 Mhz 2402 - 2480 Mhz 0.7 dBm 5.3 dB 12. FCC / IC NOTICE USA iSpiro Ultrasonic Sensor FCC ID: 2AAUFISPIRO1 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 interferences, and ( 2 ) this device must accept any interference received, including interferences that may cause undesired operation. 42 43 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 Canada iSpiro Ultrasonic Sensor Sensor Unit IC: 11335A-ISPIRO1 This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: ( 1 ) this device may not cause interference, and

( 2 ) this device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes : ( 1 ) lappareil ne doit pas produire de brouillage, et ( 2 ) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. 13. MANUFACTURER INFORMATION UK Responsible Person:

Exco Intouch Limited, 6th Floor City Gate East, Tollhouse Hill, Nottingham, NG1 5FS UK Swiss Responsible Person:

PHT Corporation SarL, Chemin Louis-Hubert 2, 1213 Petit-Lancy, Geneva, Switzerland 44 45 V01.00 Date 28 FEB 2024V01.00 - Date 28 FEB 2024 2024 eResearchTechnology GmbH or one of its affiliates All rights reserved. eResearchTechnology GmbH Sieboldstrae 3 97230 Estenfeld, Germany Tel: +49 9305 720-9891 Fax: +499305720-7891 0123 46 V01.00 Date 28 FEB 2024

eResearchTechnology GmbH | Sieboldstrasse 3 | D 97230 Estenfeld Sample Attestation Statement -FCC Date: 2024-02-20 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Attestation regarding covered equipment and the Covered List FCC ID: 2AAUFISPIRO1 To whom it may concern, Per 2.911(d)(5)(i), eResearchTechnology GmbH certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Per 2.911(d)(5)(ii), eResearchTechnology GmbH certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Sincerely, Jrgen Kasprowitsch Sr Director, QM / RA Page 1 of 1

Small Size 2.4 GHz PCB antenna Application Note AN043 By Audun Andersen 1 KEYWORDS CC25xx CC24xx CC2480 PCB antenna 2 INTRODUCTION The PCB antenna used on the CC2511 USB dongle reference design is described in this application note. Even if the antenna presented is for a USB dongle design it can be used in all 2.4 GHz designs, especially where small space is required for the antenna. This application note describes the antenna dimensions, the RF performance USB dongle 2.4 GHz Inverted F Antenna for complying with and considerations regulatory limits when using this design. The suggested antenna design requires no more than 15.2 x 5.7 mm of space and ensures a VSWR ratio of less than 2 across the 2.4 GHz ISM band when connected to a 50 ohm source. Figure 1: CC2511 USB Dongle SWRA117D Page 1 of 21 Application Note AN043 Table of Contents 1 2 3 4 KEYWORDS ................................................................................................................... 1 INTRODUCTION............................................................................................................. 1 ABBREVIATIONS........................................................................................................... 2 ANTENNA DESIGN........................................................................................................ 3 DESIGN GOALS.......................................................................................................... 3 SIMULATION............................................................................................................... 3 LAYOUT AND IMPLEMENTATION ................................................................................... 4 TEST RESULTS ............................................................................................................. 5 REFLECTION .............................................................................................................. 5 RADIATION PATTERN.................................................................................................. 7 OUTPUT POWER ...................................................................................................... 15 SPURIOUS EMISSION AND HARMONICS...................................................................... 17 CONCLUSION .............................................................................................................. 20 GENERAL INFORMATION .......................................................................................... 21 DOCUMENT HISTORY................................................................................................ 21 4.1 4.2 4.3 5.1 5.2 5.3 5.4 7.1 5 6 7 3 ABBREVIATIONS Computer Aided Design CC2400, CC2420, CC2430 and CC2431 CC2500, CC2510, CC2511, CC2550 and CC2520 Z-Accel ZigBee Processor Inverted F Antenna Industrial, Scientific and Medical Line Of Sight Printed Circuit Board Packet Error Rate Voltage Standing Wave Ratio CAD CC24xx CC25xx CC2480 IFA ISM LOS PCB PER VSWR SWRA117D Page 2 of 21 Application Note AN043 4 ANTENNA DESIGN The PCB antenna on the CC2511 USB dongle reference design is a meandered Inverted F Antenna (IFA). The IFA was designed to match an impedance of 50 ohm at 2.45 GHz. Thus no additional matching components are necessary. 4.1 Design Goals The reflection at the feed point of the antenna determines how much of the applied power is delivered to the antenna. A reflection of less than -10 dB across the 2.4 GHz ISM band, when connected to a 50 ohm source, was a design goal. Reflection of less than -10 dB, or VSWR less than 2, ensures that more than 90% of the available power is delivered to the antenna. Bandwidth is in this document defined as the frequency band where more than 90% of the available power is delivered to the antenna. Another design goal was to fit the size of the PCB antenna on a USB dongle and to obtain good performance also when the dongle is connected to a computer. 4.2 Simulation IE3D from Zeland, which is an electromagnetic simulation tool, was used to design the antenna. The accuracy of the simulation is controlled by the mesh. An increase of the mesh increases the simulation time. Thus, for initial simulations mesh = 1 should be used. When a fairly good result is achieved a higher mesh should be used to obtain more accurate results. Comparison of simulation and measurement results shows that the measured reflection is between the result obtained with mesh = 5 and mesh = 1; see Figure 2 for details. Figure 2: Comparison of Simulation and Measurements Results SWRA117D Page 3 of 21 Application Note AN043 4.3 Layout and Implementation Small changes of the antenna dimensions may have large impact on the performance. Therefore it is strongly recommended to make an exact copy of the reference design to achieve optimum performance. The easiest way to implement the antenna is to import the gerber or DXF file showing the antenna layout. These files are named IFA_USB.spl and IFA_USB.dxf respectively and are included in the CC2511 USB dongle reference design available from http://www.ti.com\lpw. The imported file can be used as a template when drawing the antenna. By using this procedure it should be possible to make an exact copy. If the PCB CAD tool being used does not support import of DXF or gerber files, Figure 3 and Table 1 should be used to ensure correct implementation. It is recommended to generate a gerber file for comparison with IFA_USB.spl when making a manual implementation. Most gerber viewers have the possibility to import several gerber files at the same time. Thus by placing the gerber file, showing the manually implemented antenna, on top of IFA_USB.spl it is easy to verify that the antenna is correctly implemented. It is also recommended to use the same thickness and type of PCB material as used in the reference design. Information about the PCB can be found in a separate readme file included in the reference design. To compensate for a thicker/thinner PCB the antenna could be made slightly shorter/longer. Figure 3: Antenna Dimensions L1 L2 L3 L4 L5 L6 W1 W2 D1 D2 D3 D4 D5 D6 3.94 mm 2.70 mm 5.00 mm 2.64 mm 2.00 mm 4.90 mm 0.90 mm 0.50 mm 0.50 mm 0.30 mm 0.30 mm 0.50 mm 1.40mm 1.70 mm Table 1: Antenna Dimensions SWRA117D Page 4 of 21 Application Note AN043 5 TEST RESULTS Reflection, radiation pattern and variation of output power across a wide frequency band were measured to verify the performance of the PCB antenna. Measurements of the dongle in free space and when connected to a laptop were performed to verify that the antenna is suitable both for USB dongle designs and in a standalone application. Free space is in this document interpreted as a measurement performed without connecting the dongle to a computer. In such a measurement the dongle is only powered by a battery. 5.1 Reflection All the reflection measurements were performed with a network analyzer connected to a semi-rigid coax cable, which was soldered to the feed point of the antenna. Because of the small size antenna and the small ground plane this kind of measurements is heavily affected by the presence and placement of the coax cable. This influence can result in a small uncertainty in resonance frequency and measured reflection. Typically different placement of the semi-rigid coax cable could change the resonance frequency with 5 -10 MHz and the reflection with 3 - 4 dB. Figure 4: Influence of Plastic Encapsulation and Test Pins SWRA117D Page 5 of 21 Application Note AN043 A small part on the CC2511 USB dongle PCB is equipped with test pins. These are intended for use during development. This part of the PCB will typically be omitted in a final application. The red and green graph on Figure 4 shows that removing this part of the PCB has a small impact on the performance. Figure 4 also shows that plastic encapsulation of the dongle will shift the resonance frequency to a lower frequency. This can be compensated by making the antenna slightly shorter. The size of the ground plane affects the performance of the PCB antenna. Connecting the USB dongle to a computer increases the size of the ground plane and thus the performance is affected. Figure 5 shows how the performance is affected when the USB dongle is connected to a laptop. In free space the antenna has a bandwidth of approximately 250 MHz. When the USB dongle is connected to the laptop the bandwidth is reduced to around 100 MHz, which still is enough to cover the whole 2.4 GHz ISM band. Figure 5: Comparison of Performance SWRA117D Page 6 of 21 Application Note AN043 5.2 Radiation Pattern The radiation pattern for the antenna implemented on the CC2511 USB dongle reference design has been measured in an anechoic chamber. Figure 7 through Figure 12 shows radiation patterns for three planes, XY, XZ and YZ, measured with vertical and horizontal polarization. All these measurement were performed without connecting the dongle to a computer. Figure 13 and Figure 14 shows the radiation pattern when the dongle is connected to a laptop. All measurements were performed with 0 dBm output power. Figure 6 shows how the different radiation patters are related to the positioning of the antenna. XY plane YZ plane XZ plane Figure 6: How to Relate the Antenna to the Radiation Patterns SWRA117D Page 7 of 21 Application Note AN043 Figure 7: USB Dongle XY Plane SWRA117D Page 8 of 21 Application Note AN043 Figure 8: USB Dongle XY Plane SWRA117D Page 9 of 21 Application Note AN043 Figure 9: USB Dongle XZ Plane SWRA117D Page 10 of 21 Application Note AN043 Figure 10: USB Dongle XZ Plane SWRA117D Page 11 of 21 Application Note AN043 Figure 11: USB Dongle YZ Plane SWRA117D Page 12 of 21 Application Note AN043 Figure 12: USB Dongle YZ Plane SWRA117D Page 13 of 21 Application Note AN043 Figure 13: USB Dongle in Laptop XY Plane SWRA117D Page 14 of 21 Application Note AN043 Figure 14: USB Dongle in Laptop XY Plane 5.3 Output Power To make a realistic bandwidth measurement of the antenna a small test program was used. The test program stepped the center frequency of a carrier from 2.3 to 2.8 GHz. This bandwidth measurement was also done to verify the result from the reflection measurements, described in section 5.1. The output power was measured using max hold on a spectrum analyzer. CC2511 was programmed for 0 dBm output power and the antenna was horizontally oriented and directed towards the receiving antenna. This corresponds to 0 in the XY plane on Figure 6. The bandwidth measurements were not performed with a correction factor on the spectrum analyzer. Thus, the results in Figure 15 and Figure 16 only show the relative changes in output power and not the actual level. Figure 15 shows the bandwidth of the antenna when the dongle is not connected to a computer. The result shows that the antenna has a variation in output power of less than 3 dB across a frequency band of more than 350 MHz. This demonstrates that the antenna has a SWRA117D Page 15 of 21 Application Note AN043 broadband characteristic. Maximum output power is measured to be at 2.54 GHz. Thus if the same antenna is implemented on a PCB with similar size and if the application is only intended for stand alone usage the antenna could be made slightly longer to obtain best performance at 2.42 GHz. Figure 15: Output Power, USB Dongle The reflection results in Figure 5 indicate that the output power will be slightly reduced when the dongle is connected to a laptop. Comparison of the results in Figure 15 and Figure 16 shows that the output power is reduced by approximately 2 dB when the dongle is connected to a laptop. This agrees with the results in Figure 5. SWRA117D Page 16 of 21 Application Note AN043 Figure 16: Output Power, USB Dongle in Laptop 5.4 Spurious Emission and Harmonics Table 2 shows measured output power and emission at the second harmonic. Above the second harmonic no peaks were detected when measuring TX emission. This can be seen from Figure 17 and Figure 18. These measurements were performed according to FCC requirements. An approximate conversion to dBm can be done by subtracting 95 from the measured value in dBV/m. Since the measurement setup for ETSI and FCC is different this conversion will not give an exact result, but typically it will give a result that is within 1-2 dB of the result from a correct ETSI measurement. Output power 2.44 GHz 4.88 GHz 1 dBm 0 dBm

-2 dBm 56.1 dBV/m 54.3 dBV/m 52.5 dBV/m Table 2: Measured Level of Output Power and Harmonics 96.9 dBV/m 96.1 dBV/m 93.1 dBV/m ETSI and FCC limits for output power and TX spurious emission are shown in Table 3. FCC allows for up to 20 dB higher emission if duty cycling is used. Thus, it is possible to use the antenna described in this document and be compliant with both ETSI and FCC regulation. SWRA117D Page 17 of 21 Application Note AN043 2.4 2.483 GHz EN 300 328 EN 300 440 20 dBm 10 dBm*

2. harm

-30 dBm

-30 dBm

*Depends on the power class.

** Depends on the number of channels being used. FCC 15.247 125 dBV/m 116 dBV/m**

54 dBV/m FCC 15.249 94 dBV/m 54 dBV/m Table 3: ETSI and FCC Limits Figure 17: TX Spurious Emission 1 5 GHz SWRA117D Page 18 of 21 Application Note AN043 Figure 18: TX Spurious Emission 5.5 8.5 GHz As opposed to FCC, ETSI has specific RX emission requirements. Table 4 and Table 5 list the ETSI RX spurious requirements. 30 MHz to 1 GHz 1 GHz to 12.75 GHz Narrowband spurious emission Wideband spurious emission

-57 dBm

-47 dBm

-107 dBm/Hz

-97 dBm/Hz Table 4: EN 300 328 RX Spurious Requirements 25 MHz to 1 GHz 1 GHz to 10 times the carrier frequency*

-57 dBm

-47 dBm

*Applies for equipment operating between 1 GHz and 20 GHz. Table 5: EN 300 440 RX Spurious Requirements The only signal detected above the noise floor when measuring RX spurious emission was the VCO leakage at 4.89 GHz. Figure 19 shows that the measured VCO leakage is below ETSI limits. SWRA117D Page 19 of 21 Application Note AN043 Figure 19: RX Spurious Emission 6 CONCLUSION This application note shows that it is possible to implement a 2.4 GHz antenna on a small area and still achieve good performance. Table 6 lists the most important properties of the Inverted F Antenna, described in this document. The free line of sight (LOS) range was measured with 250 kbps and 1 % PER. Gain in XY plane Gain in XZ plane Gain in YZ plane Gain in XY plane, connected to laptop LOS range Antenna size 4.5 dB 5.3 dB 5.3 dB 3.3 dB 240 m 15.2 x 5.7 mm Table 6: IFA Properties (Measured on CC2511 Dongle Reference Design) The results provided in section 5 shows that it is possible to comply with both ETSI and FCC regulations when implementing the suggested antenna together with CC2511 on a USB dongle. SWRA117D Page 20 of 21 Application Note AN043 7 GENERAL INFORMATION 7.1 Document History Revision SWRA117D SWRA117C SWRA117B SWRA117A SWRA117 Date 2008-04-04 2008-02-27 2007-06-01 2007-01-08 2006-11-28 Description/Changes Changed CCZACC06 to CC2480 Added reference to CCZACC06 and CC2520 Changed name of document Added more dimensions in Figure 3 and Table 1 Initial release. SWRA117D Page 21 of 21 IMPORTANT NOTICE Texas Instruments Incorporated and its subsidiaries (TI) reserve the right to make corrections, modifications, enhancements, improvements, and other changes to its products and services at any time and to discontinue any product or service without notice. Customers should obtain the latest relevant information before placing orders and should verify that such information is current and complete. All products are sold subject to TIs terms and conditions of sale supplied at the time of order acknowledgment. TI warrants performance of its hardware products to the specifications applicable at the time of sale in accordance with TIs standard warranty. Testing and other quality control techniques are used to the extent TI deems necessary to support this warranty. Except where mandated by government requirements, testing of all parameters of each product is not necessarily performed. TI assumes no liability for applications assistance or customer product design. Customers are responsible for their products and applications using TI components. To minimize the risks associated with customer products and applications, customers should provide adequate design and operating safeguards. TI does not warrant or represent that any license, either express or implied, is granted under any TI patent right, copyright, mask work right, or other TI intellectual property right relating to any combination, machine, or process in which TI products or services are used. Information published by TI regarding third-party products or services does not constitute a license from TI to use such products or services or a warranty or endorsement thereof. Use of such information may require a license from a third party under the patents or other intellectual property of the third party, or a license from TI under the patents or other intellectual property of TI. Reproduction of TI information in TI data books or data sheets is permissible only if reproduction is without alteration and is accompanied by all associated warranties, conditions, limitations, and notices. Reproduction of this information with alteration is an unfair and deceptive business practice. TI is not responsible or liable for such altered documentation. Information of third parties may be subject to additional restrictions. Resale of TI products or services with statements different from or beyond the parameters stated by TI for that product or service voids all express and any implied warranties for the associated TI product or service and is an unfair and deceptive business practice. TI is not responsible or liable for any such statements. TI products are not authorized for use in safety-critical applications (such as life support) where a failure of the TI product would reasonably be expected to cause severe personal injury or death, unless officers of the parties have executed an agreement specifically governing such use. Buyers represent that they have all necessary expertise in the safety and regulatory ramifications of their applications, and acknowledge and agree that they are solely responsible for all legal, regulatory and safety-related requirements concerning their products and any use of TI products in such safety-critical applications, notwithstanding any applications-related information or support that may be provided by TI. Further, Buyers must fully indemnify TI and its representatives against any damages arising out of the use of TI products in such safety-critical applications. TI products are neither designed nor intended for use in military/aerospace applications or environments unless the TI products are specifically designated by TI as military-grade or "enhanced plastic." Only products designated by TI as military-grade meet military specifications. Buyers acknowledge and agree that any such use of TI products which TI has not designated as military-grade is solely at the Buyer's risk, and that they are solely responsible for compliance with all legal and regulatory requirements in connection with such use. TI products are neither designed nor intended for use in automotive applications or environments unless the specific TI products are designated by TI as compliant with ISO/TS 16949 requirements. Buyers acknowledge and agree that, if they use any non-designated products in automotive applications, TI will not be responsible for any failure to meet such requirements. Following are URLs where you can obtain information on other Texas Instruments products and application solutions:

Products amplifier.ti.com Amplifiers dataconverter.ti.com Data Converters dsp.ti.com DSP www.ti.com/clocks Clocks and Timers interface.ti.com Interface logic.ti.com Logic power.ti.com Power Mgmt microcontroller.ti.com Microcontrollers RFID www.ti-rfid.com RF/IF and ZigBee Solutions www.ti.com/lprf www.ti.com/audio www.ti.com/automotive www.ti.com/broadband www.ti.com/digitalcontrol www.ti.com/medical www.ti.com/military www.ti.com/opticalnetwork www.ti.com/security www.ti.com/telephony www.ti.com/video www.ti.com/wireless Applications Audio Automotive Broadband Digital Control Medical Military Optical Networking Security Telephony Video & Imaging Wireless Mailing Address: Texas Instruments, Post Office Box 655303, Dallas, Texas 75265 Copyright 2008, Texas Instruments Incorporated

eResearchTechnology GmbH | Sieboldstrasse 3 | D 97230 Estenfeld Attn: Industry Canada & FCB Authority to Act as Agent I appoint _Element Materials Technology Straubing GmbH__ 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 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 Element Materials Technology (Element), still resides with ___eResearch Tenology GmbH Sieboldstr. 3d 97230 Estenfeld, Germany___. Dated this ___20th_____day of ____February___, 2024. Agency Agreement Expiration Date:

By:

Title:

On behalf of: ___eResearchTechnology GmbH_______________________ Telephone: ___+49 9305 720 6170_______________________ __________________________ ___ Sr Director, QM / RA_______________________ Jrgen Kasprowitsch

(Company Name) 9th May 2024

(Print name)

(Signature) Page 1 of 1

eResearchTechnology GmbH | Sieboldstrasse 3 | D 97230 Estenfeld LETTER OF AGENCY 2024-02-20 Element Materials Technology 100 Frobisher Business Park Malvern Worcestershire WR14 1BX UK To Whom It May Concern:

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, 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 for your attention to this matter. Yours faithfully Jrgen Kasprowitsch Sr Director, QM / RA eResearchTechnology GmbH Page 1 of 1

eResearchTechnology GmbH | Sieboldstrasse 3 | D 97230 Estenfeld Sample Request for Confidentiality Letter-FCC 2024-02-20 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Request for confidentiality FCC ID: 2AAUFISPIRO1 To whom it may concern, We hereby respectfully request that under the provision of 47 CFR 0.459 and 0.457(d) the documents listed below and attached with this application for certification be provided with confidential status. Schematics Operational Description Frequency Block Diagrams Bill of Materials Any exhibit / information for which we have requested confidentiality, but which may not be accorded such treatment by the FCC, should be returned to us. The documents listed above contain trade secrets that are treated as confidential by us. Substantial competitive harm to us could result should they be made available to the public. Sincerely, Jrgen Kasprowitsch Sr Director, QM / RA Page 1 of 1

eResearchTechnology GmbH | Sieboldstrasse 3 | D 97230 Estenfeld Attestation Letter Federal Communications Commission Authorization and Evaluation Division 1455 Oakland Mills Road Columbia, Maryland 21046 section 2.911(d)(7) filing This letter is to confirm that eResea rch Technology Inc. has accepted responsibility to act as the agent service of process as acknowledged by the applicant eResea Technology GmbH The U.S. Agent further agrees to the obligations define the current version of guidance documen Todd Kisner SSUrANCe egulatory ompliance Company Name:

eResearch Technology In 1818 Market Street, Suite 2600 Philadelphia

, USA Telephone No

+1 609 936 4594 kisner

@clario.com egistration Number icant 0022909717 egistration Number U.S. Agent 0034841361 The applicant acce pots and acknowledges the ob ligation to maintain an agent f or no |

ess than one year aft er the grantee has terminated all marketing and importation or the conclus Commission related proceeding involving the equipment. Signature of Applicant Signature of U.S. Agent Name:

uergen Kasprowitsch Name Todd Kisner see electronic signature see electronic signature

) A v Pan, os Na, ALLE SiR UE (RSME ARE a amend AIRE PE OND U DocuSigned by:

Quareyen Yrs prowilecn U Signer Name: Juergen Kasprowitsch Signing Reason: | approve this document

| Signing Time: 31-Jan-2024 | 10:39:09 GMT SDIDIDEC062549AD8ADFB/7D788BA2F7E 4s, ff) fe dd tna U DocuSigned by:

PAd biswer U Signer Name: Todd Kisner Signing Reason: | approve this document

| Signing Time: 31-Jan-2024 | 10:04:08 EST 6277AE7204944C23B1357C7531DFB709