Warning, Caution And Important Tip; Intended Use - 3B G3 Series User Manual

Luna G3 BPAP 25A (G3 B25A) User Manual MID-97/v1.0

3. Warning, Caution and Important Tip

WARNING!
Indicates the possibility of injury to the user or operator.
CAUTION!
Indicates the possibility of damage to the device.
IMPORTANT TIP!
Places emphasis on an operating characteristic.
Warnings, Cautions, and Important Tips appear throughout this manual as they
apply.

4. Intended Use

The Luna G3 BPAP 25A is a Bi-level PAP (Bi-level Positive Airway Pressure) device
designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated
humidifier is indicated for the humidification and warming of air from the flow
generator device. These devices are intended for single-patient use by prescription
in the home or hospital/institutional environment on adult patients. It is to be used on
patients >66 lbs./30 kg for whom CPAP therapy has been prescribed. The system
can deliver bi-level therapy or auto bi-level therapy.
WARNINGS!
• This device is intended for adult use only.
• This device is not intended for life support.
• The instructions in this manual are not intended to supersede established medical
protocols.
• To ensure that you receive the safe, effective therapy prescribed for you, use only
3B MEDICAL accessories.
• Do not bring the device or accessories into a Magnetic Resonance (MR)
environment as it may cause unacceptable risk to the patient or damage to the
device or MR medical devices. The device and accessories have not been
evaluated for safety in an MR environment.
• Do not use the device or accessories in an environment with electromagnetic
equipment such as CT scanners, Diathermy, RFID and electromagnetic security
systems (metal detectors) as it may cause unacceptable risk to the patient or
damage to the device. Some electromagnetic sources may not be apparent, if you
notice any unexplained changes in the performance of this device, if it is making
unusual or harsh sounds, disconnect the power cord and discontinue use. Contact
your home care provider.
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