Safety Information

Intended Use

The N9+ (OTC) device, combined with a smartphone application (Nonagon Care Kit), is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound, body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.
The Nonagon Care Kit is intended for use by adult lay users in a non-clinical environment. The Nonagon application enables counseling with the physician and transmission of the information over an IP network. The oxygen saturation (SpO2) sensor of the device is for Rx only.

Contra Indications

The system does not have known contraindications

Warnings

• Always adhere to all warnings and cautions. As with any electrical device, you must observe certain precautions to ensure safety.
• Do not rely on this device for medical emergency. If you think you may have a medical emergency, seek emergency medical care immediately.
• Do not disregard or delay seeking professional medical advice because of any results provided by this system.
• Do not rely on this system for decisions on taking or stopping any medication. Always seek the advice of your physician or other qualified health care provider with any questions you may have.
• To be used only by adults, 18 years old or older. Keep out of the reach of children.
• Following offline tests do not forget to send the test results without delay to the healthcare provider prior to closing the App to prevent delays in medical care.
• Use this system for its intended purpose only, as described in this User Manual.
• Use the Nonagon Care Kit supplied accessories. Use of incompatible components can result in degraded performance.
• Only a trained healthcare professional can supply interpretation of measurement results. Use of this system is not intended as a substitute for consultation with your physician.
• Do not use the N9+ System on the eyes.
• Do not allow water or any liquids to enter the N9+ System. Do not use/store the N9+ System near any sources of water or liquids.
• Check that the N9+ System is intact before use. Do not use if damaged, cracked or broken. Do not drop the devices. Do not touch the inner parts of the devices.
• This system is not serviceable. In order to maintain its safety and reliability, do not attempt to open the devices.
• This system is not fire-resistant and cannot be used after exposure to fire or high temperatures.
• Do not use the system close to explosive or highly flammable materials like alcohol, methanol, acetone, etc. Do not clean the system with alcoholic materials. Alcohol may be used for disinfection.
• Do not operate this system outside of recommended operating specifications detailed in the online user manual, or the system may fail or produce inaccurate measurement results.
• Do not operate this system in proximity to substantial emitters, such as:
• Military areas (e.g., submarines, radar installations, weapons control systems).
• Heavy industrial areas (e.g., power plants, steel and paper mills, foundries, automotive and appliance manufacturing, smelting and mining operations, oil and gas refineries).
• Aircraft environments (e.g., planes, helicopters).
• Public security systems (e.g., metal detectors, electronic article surveillance, electromagnetic anti-theft systems).
• Do not operate this system in medical treatment areas with high powered medical equipment, such as: high-frequency surgical equipment, short-wave therapy equipment, MRI system, and unique medical emitters such as electrocautery, electrosurgical units, and diathermy equipment.
• Do not store the N9+ System outside of recommended storage specifications detailed in the online user manual or the device may fail or produce inaccurate measurement results.
• Do not use the N9+ system if the smartphone being used to collect the data is damaged such that the App does not function properly.
• Replace batteries in accordance with App instructions. In case of battery leak, replace batteries.
• Verify the sensors are clean before measurement.
• Verify the smartphone camera lens is clean before camera-based measurements.
• Note that there are no physiological alarm conditions in the SpO2 device (oximeter).
• N9+ System is MR unsafe and should not enter the MRI scanner room.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the N9+ System. Otherwise, degradation of the performance of this equipment could result.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• This system is not intended for pre-term babies or light- for-date babies.
• Wash hands before the measurement procedure to avoid contamination.
• Use the system and its accessories only on intact skin. Check finger for skin integrity before touching the oximeter.
• The N9+ device does not interface with other devices using connectors or any physical means.
• Never try to connect the system with a cellular application other than the product’s certified application. Make sure you download the application found on the official Apple App Store/Google Play Store.
• Always use the most updated anti-virus software to protect your system from malicious software and viruses.
• The N9+ System including the hand-held unit, N9+ Wireless Otoscope and mobile application are designed to provide several features that protect the system against cyber threats.
• System firmware is encrypted to prevent any changes in firmware by uncertified personnel.
• The communication between the system and mobile application is encrypted by several means.
• The N9+ System complies with EU GDPR (2016/679) regulation and USA HIPAA legislation requirements to provide maximal IT protection means.
• The N9+ System does not require any user knowledge of IT systems or systems operation. The system is ready for use. No system settings are required either for device operation or connection with mobile application.
• The N9+ System and mobile application security configurations are not accessible to system users. However, users may be forced by the N9+ System to change their system log in password as part of the company’s security policy.
• Any change in N9+ System configuration should solely be done by a Nonagon qualified technician. Users should never allow access to the device to unqualified personnel.
• Do not operate the otoscope continuously for more than 2 minutes.
• If the otoscope heats up, let it cool down prior to reuse.
• Do not use the N9+ wireless otoscope while charging.
• Do not remove the otoscope cap while being charged.
• Make sure the otoscope tip is always covered, either by its cap, the ear speculum, or the tongue depressor.

Exam Specific Precautions

Oximeter Exam:

• Inadequate peripheral perfusion may preclude measurement of oxygen saturation or lead to inaccurate measurement.
• Do not press the finger down too hard, and keep your finger still.
• Make sure the sensor is covered and no light from the sensor is visible.

Ears Exam:

• After checking one ear, remove the speculum, and place a clean speculum on the otoscope before checking the second ear.
• Do not use the otoscope if you suspect there is a foreign body in the ear. Consult your doctor.
• Children under the age of 6 months should only be examined by a healthcare professional. Do not use the otoscope on children under the age of 6 months.
• For children between 6 and 24 months, it is recommended to perform the ear exam with the guidance of a healthcare professional (telehealth or your physician ) and to start with the toddler-size speculum.
• For patients above 24 months, it is recommended to start the exam with the adult speculum.
• Always use a speculum. Do not insert the wireless otoscope tip into the ear canal.
• Perform the otoscope examination carefully so as not to harm the inner parts of the ear.
• The wireless otoscope is equipped with a built-in rechargeable battery, do not throw away the charging cable.
• Do not knock or drop the otoscope. In case of product damage due to collision or falling, stop use.
• Do not use while moving and protect from being hit by passersby while using the otoscope.

Thermometer Exam:

• Clear forehead measurement area from hair and make sure it is dry before taking temperature measurement.
• Make sure the thermometer sensor is touching the area between the eyebrows and the diaphragm is also touching the forehead.
• This thermometer is not intended to interpret hypothermic temperatures.
• Intended for patients aged 2 years old and up.
• Even in the absence of fever, those who exhibit a normal temperature may still need to receive medical attention. People who are on medication should not be assessed solely on temperature readings to determine the severity of their illness. Use of the thermometer is not intended as a substitute for consultation with your physician.

Stethoscope Exam:

• Use of the stethoscope in patients under 6 months is not recommended.
• Heart, Lungs and Abdomen exams should be performed on a patient’s bare skin.
• Make sure the diaphragm is firmly in place.
• Perform the exam in a quiet room. Noises may interfere with the quality of the recording.

Mouth and Throat Exam:

• Avoid hitting the teeth when using the tongue depressor.
• In particular, be very careful if the teeth are loose or weak.
• Do not rub the tongue depressor against the tongue so as not to damage the tongue.
• Do not use the tongue depressor on small children after a meal or while lying down, so as not to cause a gag reflex, which could lead to choking or vomiting.

Note: When performing the mouth and throat exam, always use the tongue depressor- to cover the tip of the otoscope before inserting it into the mouth and throat.

Cautions

• Dispose of the system only according to electrical devices’ federal, state, local, and hospital regulations, as applicable.
• Dispose of the batteries only in a batteries recycling bin.
• If the connection is unstable, try to change your position, make sure any other wireless devices in the vicinity are turned off or are kept away from the N9+ System and smartphone during operation.
• Do not move the smartphone away from the room where the N9+ device or N9+ wireless otoscope are in use. This assures proper pairing and minimizes potential disruptions in wireless data transfer.
• Keep the N9+ System more than 15 cm (6 inches) away from RF emitters such as smartphones.
• 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 radiation frequency energy and if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. 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:

1. Reorient or relocate the receiving antenna.
2. Increase the separation between the equipment and receiver.
3. Consult the dealer or an experienced radio/TV technician for help.

Notes

• Remove the battery if the N9+ device is not likely to be used for some time.
• The system is not intended for continuous remote monitoring of critical patients.
• Report unexpected operation or events to your product’s customer support service.
• As the N9+ is battery operated and the Otoscope is equipped with USB cable, you can travel with the device.