User's Manual

RXiBreeze PAP System User Manual
2
User qualifications
The person operating the device by the instruction in the user’s manual is referred as
the “user”. In contrast, a “patient” is the person receiving the therapy. Always perform all
the operating steps in accordance with the user’s manual.
Some lay person can receive specified professional training about how to use the
device including all related to accessories from your dealer or the manufacturer.
4 Safety Information
WARNING: Indicate the possibility of injury to the user or the operator.
CAUTION: Indicate the possibility of damage to the device.
WARNING:
 This manual serves as a reference. The instructions in this manual are not intended
to supersede the health care professional’s instructions regarding the use of the
device.
 This device is not intended for life support.
 A mask should not be used unless the device is turned on, otherwise, there is
danger of suffocation.
 The device must be used only with the masks and accessories recommended by
Resvent. The masks and accessories are validated for use with Resvent devices.
 The exhalation port(s) associated with the mask should never be blocked. The
device is intended to be used with special masks or connectors that have exhalation
ports to allow continuous flow of air out of the mask. When the device is turned on
and functioning properly, new air from the device flushes the exhaled air out through
the mask exhalation port. However, when the device is not operating, enough fresh
air will not be provided through the mask.
 If you are using a full-face mask (a mask covering both your mouth and your nose),
the mask must be equipped with a safety (entrainment) valve.
 When using oxygen with this system, always make sure that the device is turned on
and airflow generated before the oxygen supply is turned on. Always turn the
oxygen supply off before the device is turned off, so that unused oxygen does not
accumulate within the device enclosure and create a risk of fire.
 Sources of oxygen must be located more than 1 m from the equipment to avoid the
risk of fire and burns.
 Do not connect the device to an unregulated or high-pressure oxygen source.
 Oxygen must not be used while smoking or in the presence of an open flame.
 Do not use the device in the presence of a flammable anaesthetic mixture in
combination with oxygen or air, or in the presence of nitrous oxide.
 Do not use the device near a source of toxic or harmful vapors.
 Do not use this device if the room temperature exceeds 35°C (95°F). If the device is
used at room temperatures warmer than 35°C (95°F), the temperature of the airflow
may exceed 43°C (109°F). This could cause irritation or injury to your airway.
 The time required for the CPAP System to warm from the minimum storage
temperature between uses until the CPAP System is ready for its intended use
when the ambient temperature is 20
℃
is at least 1h, and
 The time required for the CPAP System to cool from the maximum storage
temperature between uses until the CPAP System is ready for its intended
use when the ambient temperature is 20
℃
(68°F) is at least 1h.
 The device is not used beyond the specified temperature range.