3.2.3 To avoid burns:
• Do not fill the Water Chamber with hot water.
• After use, wait for the water to cool before touching, carrying or emptying the Water Chamber.
• Do not touch the water in the Water Chamber while the device is operating.
• Position the ThermoSmart Breathing Tube so it is uncovered and free from bedding or other materials.
3.2.4 Other:
• Ensure the device is stored and operated on a surface, level or below head height, to prevent water
entering the tubing and the device enclosure.
• The device is not intended to be used as a life-supporting device.
• The device complies with the electromagnetic compatibility requirements of IEC60601-1-2. In certain
circumstances the device may affect or be affected by nearby portable mobile radio frequency
communication equipment, due to the effects of electromagnetic interference. If this should happen, try
moving your device or the location of the equipment causing interference, or alternatively consult your
healthcare provider.
• Do not block the exhaust flow holes of the mask as they are designed to allow a continuous flow of air
out of the mask and if blocked CO
• In the event of power failure, machine malfunction or if the device is turned off, remove the mask
immediately as the flow through the mask may be insufficient to clear all exhaled gas, which may result in
CO
re-breathing occuring that can be hazardous.
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• The device is not suitable for use in environments with flammable anaesthetic mixtures with air or oxygen
or nitrous oxide.
3.2.5 To ensure optimal therapy:
• Do not operate the device, Water Chamber, or breathing tube if it is dropped, damaged or not working as
intended.
• Pressure adjustments should only be made by a qualified healthcare provider.
• Only use masks, breathing tubes and accessories compliant with ISO 17510-2, distributed for use with
this device, and recommended by Fisher & Paykel Healthcare or your healthcare provider.
• On models without automatic altitude adjustment, ensure the altitude level is manually adjusted to ensure
optimal pressure delivery.
• Do not use the device without a Water Chamber in place.
• If using the device without water in the Water Chamber it is recommended to set the humidity level to zero.
3.2.6 Using supplemental oxygen with your device:
• Supplemental oxygen can be administered at the mask end of the breathing tube.
NOTE: At a fixed flow rate of supplemental oxygen the inhaled oxygen concentration will vary, depending
on the pressure settings, the patient's breathing pattern, mask selection and leak rate.
• Ensure there is no obstruction downstream of the Oxygen Port as this can affect the delivered oxygen
concentration.
• Oxygen concentration should be measured at the point of delivery to the patient.
• Avoid the risk of fire:
• Only use oxygen when the device is operating. If the device is turned off it can lead to accumulation of
oxygen within the device.
• Ensure adequate ventilation is provided around the device.
• Remove any source of ignition: such as cigarettes, an open flame, or materials which burn or ignite
easily at high oxygen concentration.
• Keep oxygen regulators, cylinder valves, tubing, connections and all other oxygen equipment away from
oil, grease or greasy substances. Spontaneous and violent ignition may occur if these substances come
into contact with oxygen under pressure.
re-breathing may occur.
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