RESmart GII BPAP System Y / U Series User Manual V2.1
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2. Warning, Caution and Important Tip
WARNING!
Indicate the possibility of injury to the user or operator.
CAUTION!
Indicate the possibility of damage to the device.
IMPORTANT TIP!
Place emphasis on an operating characteristic.
Warnings, Cautions, and Important Tips appear throughout this manual as they apply.
3. Intended Use
BPAP System (Y/U Series) is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which
is intended to provide non-invasive ventilation for patients with obstructive Sleep Apnea
(OSA) and Respiratory Insufficiency. These devices are intended for adult patient by
prescription in the home or hospital/institutional environment.
This device is not intended for life support.
The optional Heated Humidifier used with the Y/U Series together is indicated for taking
humidifying and heating air from the device.
The optional SpO
2
module used with the Y/U Series together is indicated for monitoring the
patient's SpO
2
and pulse rate auxiliarily.
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 BMC
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.
CAUTIONS!
• This device is restricted to sale by or on the order of a physician.
• The device is intended for use by operators trained or experienced in similar equipment.
• The patient is an intended operator.
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General