Nox S2 FCC User Manual Item Product FCC ID FCC rule Wireless technology Operating frequency Antenna Power source Use condition Instructions for FCC equipment authorization Information Nox S2 V5A-NOXS2 47 CFR Part 15, Subpart C, 15.247 Bluetooth Low Energy (BLE), Bluetooth 5.0 2402 MHz to 2480 MHz Integral onboard Type-F PCB antenna, non-user-replaceable Internal non-replaceable CR2032 lithium coin cell battery, 3 V Single-patient use; worn over clothing during sleep study 1. Purpose This draft user manual provides installation and operating instructions for the Nox S2 device for FCC equipment authorization under 47 CFR 2.1033. 2. Intended Use and Users The Nox S2 System is a portable system intended for the ambulatory recording of physiological signals during sleep using patient-applied sensors. The recorded data is transferred to secure cloud storage and made available for further processing using external sleep study software. The Nox S2 System allows physiological signals to be recorded during sleep tests conducted to aid Healthcare Professionals in diagnosing sleep disorders. The Nox S2 System is intended for patients 18 years of age or older suspected of having sleep-related breathing disorders. It is intended for use in clinical and home settings. Intended users are lay users and Healthcare Professionals. Lay users should know how to use a smartphone or mobile app. 3. System Description The Nox S2 device is a lightweight, battery-powered, single-patient-use device used to measure breathing effort during sleep. The Nox S2 is intended to be worn over clothing. The device is used with Nox RIP belts placed around the chest and abdomen. During use, the Nox S2 device transmits data to the Nox Sleep Study mobile application using Bluetooth Low Energy. The mobile application is used to set up and start the sleep study recording and to receive data from the Nox S2 device. The Nox S2 device records thorax and abdomen respiratory effort, body position, and activity. The Nox S2 device has no internal storage and sends data to the mobile application. The Nox S2 device is single-patient use only and is disposed of after the sleep study is completed. The battery is internal and non-replaceable. Do not attempt to open the device or replace the battery. 4. Radio Description The Nox S2 contains an intentional Bluetooth Low Energy transmitter operating under 47 CFR Part 15, Subpart C, 15.247. Parameter Specification Radio chipset Wireless technology PHY / data rate Modulation Operating frequency Tested channels Rated transmit power Measured maximum EIRP Antenna User controls Nordic Semiconductor nRF52832 system on chip Bluetooth Low Energy (BLE), Bluetooth 5.0 LE 1M PHY and LE 2M PHY; up to 2 Mbps Gaussian Frequency Shift Keying (GFSK), Adaptive Frequency Hopping (AFH) 2.402 GHz to 2.480 GHz 2402 MHz, 2442 MHz, and 2480 MHz
+4 dBm conducted setting Up to approximately 5.916 dBm based on the submitted operational description Internal onboard Type-F PCB antenna, 1.9 dBi gain, non-user-replaceable The user cannot adjust frequency, modulation, packet format, antenna, or RF output power. 5. Installation and Operating Instructions 5.1 Before Use Use the Nox S2 only as instructed by a Healthcare Professional. Use only Nox Medical-approved accessories and compatible devices. Do not use damaged equipment or sensors. Do not use the same Nox S2 device on more than one patient. Do not clean, maintain, service, open, or modify the Nox S2 device. 5.2 Hook-Up Take the elastic belt and attach one end to the back connector on the Nox S2 chest unit. Make sure it is fully connected. Put on a T-shirt before placing the chest belt. Wrap the belt around the chest so it sits flat and feels comfortable. Attach the free end of the belt to the second connector to make a loop. Make sure the cable points downward and that the belt is not twisted. Attach the abdomen belt in the same way around the abdomen. When setup is complete, press the button on the chest unit to turn on the Nox S2 device. 5.3 Mobile Application Setup Open the Nox Sleep Study mobile application on the compatible smartphone or tablet. Follow the app instructions to scan the QR code or enter the study details manually. Make sure the required devices are connected before starting the recording. Keep the smartphone or tablet nearby during the recording so the Bluetooth connection can be maintained. To avoid interruptions during the recording, keep the smartphone or tablet connected to a power source. 5.4 Recording Tap Start Recording in the mobile application after the required devices are ready. The app displays recording time and device connection status during recording. When the study is complete, follow the app instructions to stop and upload the recording. Make sure the smartphone or tablet is connected to the internet for upload. 5.5 End of Use and Disposal The Nox S2 device is single-patient use only. After the sleep study is complete, dispose of the Nox S2 device according to local regulations and recycling rules. The device contains electronic parts and an internal non-
replaceable lithium coin cell battery and should not be disposed of as unsorted household waste where electronic waste collection is available. 6. Warnings and Cautions Do not use damaged equipment or sensors. Damaged parts may cause poor performance or injury. Place cables and connections carefully to reduce the risk of tangling or strangulation. Do not use the same Nox S2 on more than one patient. This may cause cross-contamination and spread infection. Do not use any part of the Nox S2 System, including RIP belts, in a Magnetic Resonance (MR) Imaging environment. Do not use the Nox S2 near flammable anesthetic gases or mixtures with air, oxygen, or nitrous oxide. Remove the Nox S2 before defibrillation. Do not use the Nox S2 System or accessories during X-ray or radiography procedures. Do not use the Nox S2 with high-frequency (HF) equipment. Keep wireless communication equipment at least 30 cm (12 inches) away from the Nox S2 System and its cables, unless needed for intended Bluetooth operation with the mobile application. Do not change the Nox S2 or use unapproved accessories. Use only accessories approved by Nox Medical. U.S. federal law restricts this device to sale by, or on the order of, a physician. 7. FCC Compliance Statements FCC ID: V5A-NOXS2 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 Nox Medical could void the user's authority to operate the equipment. The Nox S2 device is not a medical implant and is not designed to be used within the human body. The Nox S2 device does not operate in the 6 GHz band. 8. RF Exposure Information The Nox S2 is a low-power Bluetooth Low Energy body-worn device intended to be worn over clothing using the Nox S2 configuration and accessories specified by Nox Medical. To maintain RF exposure compliance, use the Nox S2 only as described in this manual. Do not modify the device, antenna, enclosure, firmware, or radio settings. Do not use antenna accessories, external antennas, or non-approved body-worn accessories with the Nox S2. The integral onboard antenna is not user replaceable. The user must not attempt to open the device or alter the antenna. 9. Operating Environment Condition Intended environment Operating temperature Operating relative humidity Operating atmospheric pressure Transport and storage temperature Transport and storage relative humidity Ingress protection Value Clinical and home settings
+5C to +40C (+41F to +104F) 10% to 90% (non-condensing) 700 hPa to 1060 hPa
-25C to +70C (-13F to +158F) 10% to 95% (non-condensing) IP22 10. Compatible Devices and Accessories Use only Nox Medical-approved accessories and compatible devices. The Nox S2 is used with Nox RIP belts and the Nox Sleep Study mobile application. User action Grant Bluetooth permissions in the mobile device operating system. Turn on Bluetooth to connect to devices. Keep the Nox S2 close to the mobile device and follow the app instructions to try again. Connect the smartphone or tablet to a power source before or during recording. Free up storage on the mobile device and try again. Connect the mobile device to the internet and follow the app instructions to upload the recording. 11. Troubleshooting Issue Bluetooth permissions required Bluetooth is turned off Device not connected Low phone battery Low storage on mobile device No internet connection during upload 12. Manufacturer Nox Medical ehf Katrinartuni 2, 105 Reykjavik, Iceland Website: www.noxmedical.com.
