Resvent iBreeze Series User manual

Contents

iBreeze CPAP Systems User Manual
1 Welcome
The iBreeze CPAP Systems contains CPAP and APAP Modes. They are both
continuous positive airway pressure devices.
The iBreeze CPAP Systems include the following models:
iBreeze 20C Breeze 20C Pro iBreeze 20A iBreeze 20A Pro.
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 Use
CPAP systems delivery positive airway pressure therapy for the
treatment of Obstructive Sleep Apnea (OSA) in spontaneously breathing patients
weighting over 30kg (66lbs), it is for use in the home, hospital, or institutional
environment.
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 20 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 CPAP
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 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 Pneumothorax.
The use of positive airway pressure therapy may be temporarily contraindicated if you
exhibit signs of a sinus or middle ear.
Note: In either case above, it can only be determined by a competent physician
whether to use CPAP device.

iBreeze CPAP Systems User Manual
User qualifications
The person operating the device by the instruction in the user s manual is referred as
erson receiving the therapy. Always perform
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
CAUTION: Indicate the possibility of damage to the device.
WARNING:
This manual serves as a reference. The instructions in this manual are not intended
device.
This device is not intended for life-supporting device.
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 functioned 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.
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 device is not used exceed the specified temperature range.
Do not operate the device in direct sunlight or near a heating appliance because
these conditions can increase the temperature of the air coming out of the device.
Contact your health care professional if symptoms of sleep apnea recur.
If you notice any unexplained changes in the performance of this device, if it is
making unusual or harsh sounds, if it has been dropped or mishandled, if water is

iBreeze CPAP Systems User Manual
spilled into the enclosure, or if the enclosure is broken, disconnect the power cord
and discontinue use. Contact your home care provider.
Repairs and adjustments must be performed by Resvent authorized service
personnel only. Unauthorized service could cause injury, invalidate the warranty, or
result in costly damage.
Do not use any accessories, detachable parts, and materials not recommended by
Resvent. Incompatible parts or accessories can result in degraded performance.
The Health Industry Manufacturers Association recommends that a minimum
separation of 16cm be maintained between a wireless phone and a pacemaker to
avoid potential interference with the pacemaker.
Use only power cords supplied by Resvent for this device. Use of power cords not
supplied by Resvent may cause overheating or damage to the device and may
result in increased emissions or decreased immunity of the equipment or system.
The device should not be used while stacked or in close approximation to other
non-approved devices.
Use only approved cables and accessories. Misuse may affect EMC performance
and should be avoided.
Inspect the tubing for damage or wear. Discard and replace the tubing as
necessary.
Periodically inspect electrical cords and cables for damage or signs of wear.
Discontinue use and replace if damaged.
To avoid electrical shock, always unplug the power cord from the wall outlet before
cleaning the device. DO NOT immerse the device in any fluids.
Be sure to route the power cord to the outlet in a way that will prevent the cord from
being tripped over or interfered with by chairs or other furniture.
This device is activated when the power cord is connected.
For safe operation when using a humidifier, the humidifier must always be
positioned below the breathing circuit connection at the mask. The humidifier must
be level for proper operation.
Nebulization or humidification can increase the resistance of breathing system
filters and the operator must monitor the breathing system filter frequently for
increased resistance and blockage to ensure the delivery of the therapeutic
pressure.
Please check whether there is water in the device before use. The maximum fill
level is 290 mL.
Failure to use a mask or accessory that minimizes re-breathing of carbon dioxide or
permits spontaneous breathing can cause asphyxiation.
Do not connect breathing tubes or accessories with any humidifier and ventilator
that are not specified for use with these breathing tubes or accessories.
Do not cover or heat the breathing tube with anything influent the patient end
temperature.
Do not use this device outside the specified ambient temperature range or humidity
range. The humidity performance of the device can be compromised when used
outside the specified ambient temperature range or humidity range.
Parts of the equipment are not serviced or maintained while in use with the patient.
The PATIENT is an intended OPERATOR.
The Patient can safely use therapy functions of the equipment and this equipment
shall not be serviced or maintained while in use with the patient.
Please first check the breathing tube is connected correctly to avoid strangulation
risk due to breathing tube and hoses when used.
Do not pull or stretch the tubing. This could result in circuit leaks.