Patients with the following conditions should NOT use the Aluna device. Applicable age range is indicated below in the following format (min-max).
- Implanted electronic medical device [including, but not limited to, pacemakers, cochlear implants, glucose biosensors, and nerve stimulators] (5-79)
- Current painful ear infection (5-15)
- Eye surgery in the last 3 months (5-79)
- Chest/abdominal surgery in last 3 months (5-79)
- Study participant or household member tuberculosis exposure (5-79)
- History of aneurysm or collapsed lung (5-79)
- History of detached retina (16-79)
- Stroke or heart attack in the last 3 months (16-79)
- History of coughing up blood in last month (5-79)
- Do not use the Aluna device system to diagnose, prevent, or treat any condition, or to substitute for professional medical care. If knowing your FEV1 and PEF is critical to your health, have your spirometry measurement taken by a medical professional. Otherwise serious health conditions may result.
- Read all the information in this user manual before using the Aluna device. If you do not understand or have questions about your PEF and FEV1 meter and its use, consult your physicians or other licensed healthcare professional. Otherwise the effectiveness of the Aluna device system may be diminished.
- Use Aluna measurements and statistics only for informational and educational purposes and in support of general health and wellness. Overreliance on the Aluna device system may result in inadequate medical care.
- Do not use the Aluna device system as a substitute for a clinical spirometer. The Aluna device system has been tested only on individuals with health conditions of a limited nature and may not provide the level of advice needed for users requiring a clinical spirometer.
- Consult with your medical professional before modifying any regimen, including medication dosage, as a result of information from Aluna. Otherwise, overdosage or underdosage may occur.
- Contact your physician or licensed health care professional if you have signs and symptoms such as chest tightness, shortness of breath, coughing, or wheezing. Life-threatening conditions may be present.
- Remove all previous data from the Aluna Spirometry App if another person intends to use the device permanently. Failure to do so may result in messages inappropriate for the new user.
- Do not use the Aluna device system without adult supervision if you are under age 18, elderly, or are cognitively impaired. The effectiveness of the Aluna device system may be diminished.
- Do not use the Aluna device while walking or running. Injury may result in the event that you fall.
- Inspect the Aluna device before using. Do not use the device if it appears damaged. Injury may occur.
ELECTRIC SHOCK HAZARD WARNING
Do not attempt to take a measurement while the device is connected to an AC power source through the charging cable provided. Connection of the device to AC power is intended only to charge the internal lithium ion battery while the device is not being used. Not heeding this warning could expose user to electric shock hazard.
SINGLE USER DEVICE WARNING
Aluna is intended for a single user. Cross-contamination may occur if a single device is used by multiple patients.