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Resvent iBreeze 25STA - Device Purpose and Restrictions; Intended Uses; Contraindications for BPAP Therapy

Resvent iBreeze 25STA
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iBreeze BPAP Systems User Manual
1
1 Welcome
The iBreeze BPAP Systems are Resvent's premium bilevel positive airway pressure
devices.
The iBreeze BPAP Systems include the following models:
iBreeze 25S, iBreeze 25A, iBreeze 25ST, iBreeze 25STA.
Responsibility on the Manufacturer Party
Resvent is responsible for the effects on safety, reliability and performance of this
product, only if:
All installation operations, expansions, changes, modifications and repairs of
this product are conducted by Resvent authorized personnel.
All spare parts for repair, accessories, consumable are conducted by Resvent or
the authorized personnel.
The electrical installation of the relevant room complies with the applicable
national standard and the manual requirements.
The product is used in accordance with the instruction for use.
IMPORTANT
Read this entire guide before using the device.
2 Intended Uses
The iBreeze™ BPAP systems delivery positive airway pressure therapy for the
treatment of Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary
Diseases (COPD) in spontaneously breathing patients weighting over 30kg (66lbs), it is
for use in the home, hospital, or institutional environment.
The system is also intended for spot-check transcutaneous measurement of oxygen
saturation (SpO2) in the blood using light detection given from a special probe for adults
and pediatrics.
3 Contraindications
When assessing the relative risks and benefits of using this equipment, the clinician
should understand that this device can deliver pressures up to 30 cmH2O. In the event
of certain fault conditions, maximum pressure 40 cmH2O is possible. Studies have
shown that the following pre-existing conditions may contraindicate the use of BPAP
therapy for some patients
Severe coronary artery disease
Bullous Lung Disease
Pathologically Low Blood Pressure
Bypassed Upper Airway
Pneumothorax
Caution should be used when prescribing BPAP for susceptible patients such as those
with: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history
of head trauma, and/or Pneumothorax.
The use of positive airway pressure therapy may be temporarily contraindicated if you
exhibit signs of a sinus or middle ear.

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