Indications For Use; Contraindications; Warnings - Yuwell YH-550 User Manual

1. Indications for use

The YH-550 self-adjusting device and YH-350 are indicated for the treatment of Obstructive Sleep
Apnea (OSA) in patients weighing more than 66 lb (30 kg). They are intended for home use only.
YH-550 and YH-350 consist of main device, water tank and power adapter. Mask and air tube are
purchased. Mask and air tube are type BF applied part. The patient is an intended operator.

2. Contraindications

Positive airway pressure therapy may be contraindicated in some patients with the following pre-
existing conditions:
Severe bullous lung disease, pneumothorax, pathologically low blood pressure, dehydration,
cerebrospinal fluid leak, recent cranial surgery, or trauma

3. Warnings

y Do not maintain the device while it is in use, otherwise it may lead to unacceptable risk.
y Do not modify this equipment without authorization of the manufacturer or open this device by
yourself, contact YUWELL when the device need to be repaired.
y This device cannot be used for life support. It may be shut down by turning off the electricity, but
no unacceptable risk will happen.
y The device can't be used in the environment where the air is mixed with flammable anesthetic
gases or nitrous oxide gases. (Non-AP and Non-APG series PAP)
y The sources of oxygen must be located more than 1 m from the BreathCare PAP to avoid the risk
of fire and burns.
y Supplemental oxygen must not be used while smoking or in the presence of an open flame.
y 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 will not accumulate within the device enclosure or create a risk of fire.
y Make sure that you arrange the cables and air tube so that they will not twist around the head or
neck. Otherwise it may result in strangulation.
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y If you notice any unexplained change in the performance of the device, if it is making unusual
sounds, if the device or the power supply are dropped or mishandled, or if the enclosure is broken,
discontinue use and power off the equipment, then contact your provider or YUWELL Service
Center.
y Do not place the device where it can be bumped or where someone is likely to trip over the power
cord.
y Do not block the air tube and/or air inlet of the device while in operation otherwise it could cause
overheating of the device.
y Keep the area around the device dry, clean and clear of anything (e.g. clothes, bedding, lint,
dust or direct sunlight) that could block the air inlet, cover the power supply unit, affect patients'
breathing or reduce the life of device.
y Place the device on the stable table. Placing device on the soft, out of flatness surface is forbidden.
y Keep device far away from water.
y Make sure the power cord and plug are in good condition and the equipment is not damaged.
y Keep the power cord away from hot surfaces.
y Beware of electrocution. Do not immerse the device, power supply or power cord in water. If liquids
are spilled into or onto the device. Unplug the device and let the parts dry naturally and contact
YUWELL Service Center.
y Always unplug the device before cleaning and make sure that all parts are dry before plugging it
back in.
y This device cannot be used for multiple patients.
y Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
y Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
y Portable RF communications equipment (including peripherals such as antenna cables and
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