6
1. Safety Information
Contraindications
When assessing the relative risks and benefits of using this equipment, the clinician
should understand that this device can deliver pressures up to 20 cm H
2
O. In the event
of certain fault conditions, a maximum pressure of 40 cm H
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 fluid (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.
Safety Symbols Glossary
The following symbols may appear on the device and accessories:
Symbol Title and Meaning
Reference
Operator’s manual; operating instructions
Consult instructions for use.
IEC 60878
ISO 7000-1641
Symbol 5.4.3, ISO
15223-1
Approved for airline use.
RTCA/DO-160G section
21, category M
AC power (Alternating current)
Indicates on the rating plate that the equipment
is suitable for alternating current only; to identify
relevant terminals.
IEC 60417-5032
Separate collection for electrical and electronic
equipment.
EC Directive 2012/19/
EU
