Philips DreamStation 2 - Safety Information; Intended Use, Important, Contraindications

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1. Safety information
Intended use
The DreamStation 2 CPAP/DreamStation 2 Auto CPAP system delivers positive airway
pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing
patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional
environment.
Important
The device is to be used only on the instruction of a licensed physician. Your home care
provider will set the correct pressure settings and will provide accessories according to your
health care professional’s prescription.
Several accessories are available to make your OSA treatment with the DreamStation 2 system
as convenient and comfortable as possible. To ensure that you receive the safe, eective
therapy prescribed for you, use only Philips Respironics approved accessories.
Contraindications
When assessing the relative risks and benets of using this equipment, the clinician should
understand that this device can deliver pressures up to 20 cmH
2
O. In the event of certain fault
conditions, a maximum pressure of 40 cmH
2
O is possible. Studies have shown that the following
pre-existing conditions may contraindicate the use of CPAP therapy for some patients:
• Bullous Lung Disease
• Pathologically Low Blood Pressure
• Bypassed Upper Airway
• Pneumothorax
• Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway
Pressure. Caution should be used when prescribing CPAP for susceptible patients such
as those with: cerebral spinal uid (CSF) leaks, abnormalities of the cribriform plate, prior
history of head trauma, and/or pneumocephalus. (Chest 1989; 96:1425-1426)
The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit
signs of a sinus or middle ear infection. Not for use with patients whose upper airways are
bypassed. Contact your health care professional if you have any questions concerning your
therapy.