Usage
The AeviceMD Device is a non-invasive device intended to longitudinally acquire, record and store chest sounds. The AeviceMD Monitoring System is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the chest area, reported as wheeze. It is also intended to provide continuous measurement of heart rate and respiratory rate. The device stores these data which can be viewed by users on a mobile app and for later playback, review, and analysis by healthcare professionals on a Web App. The AeviceMD Monitoring System is intended for patients aged 3 years and above.
Contraindications
The AeviceMD Device should not be used on non-intact, non-healthy skin. This includes but is not limited to the following: rashes, open sores, lesions, cuts, scratches, scabs, burns, and blisters. If you are not able to determine your suitability of using this device, do not use it without consultation with a licensed healthcare professional.
The AeviceMD should not be used during an MRI scan or in a location where it will be exposed to strong electromagnetic forces.
Warnings and Cautions
This chapter outlines the Warnings and Cautions associated with using and operating the AeviceMD. Read this chapter before using or operating the AeviceMD for the first time.
Warnings
- DO NOT start or operate the AeviceMD unless the setup was verified to be correct. Consult the section “Using the AeviceMD '' to ensure that the setup is correct.
- DO NOT use the AeviceMD as a stand-alone diagnostic monitor for vital signs, cardiovascular diseases, pulmonary diseases, and cardiopulmonary diseases. The data provided by the AeviceMD is intended to aid in the evaluation process of the patient’s health by a healthcare professional. You should consult a healthcare professional if you are feeling unwell.
- The device may be a choking hazard and may be harmful if swallowed.
- DO NOT adjust, repair, open, disassemble, or modify any components of the device. Injury to user, operator, or equipment damage could occur. Return the device to Aevice Health Pte Ltd for servicing if the device has been damaged (cracked, bent, or broken).
- DO NOT continue the use of the AeviceMD Sensor should the patient’s skin become irritated or inflamed around the AeviceMD Sensor or the AeviceMD Silicone Patch. Continued use may result in the worsening of the condition. Consult a healthcare professional immediately in the case of condition worsening.
- DO NOT use any accessories or methods that are not described in this document with the system. Doing so may lead to electrical and fire safety hazards. Discontinue the power supply to the device immediately in the case of a safety hazard.
- DO NOT wear the AeviceMD Sensor or AeviceMD Silicone Patch if it is dirty. Clean it according to the Cleaning and Storing instructions in this user manual before use. Failure to thoroughly clean the device may prevent adequate disinfection, which poses a risk of infection to patients.
- DO NOT use the AeviceMD Docking Station and AeviceMD Sensor on any patient without cleaning according to the Cleaning and Storing instructions in this user manual first. Consult a healthcare professional immediately in the case of inflammation or irritation.
- DO NOT dismantle the components of AeviceMD during the cleaning process. Should the internal components be exposed, disconnect all power supplies if not already disconnected and contact Aevice Health Pte Ltd at support@aevice.com.
- The AeviceMD is not MRI-compatible. The device is MR Unsafe because it contains electrically conductive components and should not be worn near a MR environment.
- The AeviceMD is not an apnea monitor.
Cautions
- DO NOT expose the AeviceMD Device to extremely hot, cold, humid, or wet conditions. The AeviceMD Docking Station should not be placed near a water source or at a location where spillage of water is likely to occur.
- DO NOT use the AeviceMD Device in the presence of flammable substances and gases.
- DO NOT use the AeviceMD Device on patients with pacemakers.
- DO NOT use the AeviceMD Device during or immediately after physical activity.
- DO NOT submerge the AeviceMD Sensor fully or partially in liquid while cleaning as this will result in damage. The AeviceMD Sensor is dust and splash proof but it is not waterproof.
- DO ensure that the AeviceMD Sensor is completely dry before placing it back on the AeviceMD Docking Station or using it again.
- DO NOT exceed 14 hours of use for an AeviceMD Silicone Patch in a single usage. DO NOT reuse the AeviceMD Silicone Patch beyond the recommended 7 uses under prescribed conditions.
- DO NOT share the AeviceMD Device if it has been used on a patient with a communicable skin condition. If the AeviceMD Device is to be shared among other patients, wipe down the AeviceMD Sensor and AeviceMD Docking Station with 70% isopropyl alcohol using materials such as gauze, cloth, or swab to avoid cross infection.
- DO NOT use adhesive tapes in place of the AeviceMD Silicone Patch and/or to reinforce the AeviceMD Sensor. Using other adhesives may reduce the AeviceMD Sensor’s performance or result in other unintended outcomes.
- DO NOT operate in close vicinity to other equipment emitting ultrasonic waves or other acoustics.
- DO NOT use the AeviceMD Device in close proximity to other wireless electronic devices as these may cause signal interference during data transmission.
- DO NOT use accessories and cables other than those provided or specified by the manufacturer of this equipment.
- DO NOT operate this AeviceMD Device in or near water. This may result in a shock hazard and/or may damage the Device.
- DO NOT plug the AeviceMD Power Adapter into a power outlet which is obscured from view or in an area where it may be difficult to switch off or unplug the AeviceMD Power Adapter to discontinue the supply of power.
- DO NOT connect, pair, or operate the AeviceMD Device with wireless equipment other than specified or provided by the manufacturer. This may result in device malfunction or a safety hazard.
- Depending on wireless connectivity, a temporary short interruption of data transmission is possible, which may impact monitoring. Data will be stored on the AeviceMD Device for transfer once the connectivity is reestablished.
- All interpretations should be reviewed by a healthcare professional for clinical decision-making.
- (For use within the United States of America) Federal law restricts this device to sale by or on the order of a physician; and use is restricted to, by, or on the order of a physician.
Precautions
- Do NOT expose the AeviceMD Device to environmental conditions unsuitable for the storage, transport, or operation of the device.
- DO allow the device to sit at room temperature without plugging into a power supply for at least 15 minutes before use if stored in a different environmental condition.
- DO NOT attempt to clean any component of the AeviceMD Device by any method other than those listed in this user manual. Using unvalidated cleaning methods may damage the equipment or cause harm to persons.
- DO ensure hands are clean and dry before handling the AeviceMD Sensor or the AeviceMD Silicone Patch.
- DO clean the AeviceMD Silicone Patch after every use.
- DO NOT use the AeviceMD Device for any purposes other than described in the indications for use.
- DO only use the AeviceMD Power Adapter and Cable to charge/power up the AeviceMD Device.
- DO NOT operate, transport, or store the AeviceMD in an environment exceeding the ranges specified in the technical specifications.
- DO NOT use the AeviceMD Device if it is missing parts or accessories.
- DO NOT share the AeviceMD Silicone Patch with other patients. Ensure that the same patient uses the same AeviceMD Silicone Patch under prescribed conditions.
- DO ensure that the AeviceMD Sensor is always used in the same room as the AeviceMD Docking Station (no more than 32 feet (10 meters) away from the AeviceMD Docking Station) for the best results. The AeviceMD Docking Station must be powered on during every use.
- DO NOT plug in or remove the AeviceMD Power Adapter for the AeviceMD Docking Station with wet hands to the avoid risk of electric shock. Ensure that your hands are dry before touching the AeviceMD Power Adapter.
- DO fully charge the AeviceMD Sensor at least once every six (6) months to prevent premature battery degradation.