HiFent BPAP HF User Manual

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Shenyang RMS Medical Tech Co.,Ltd

Noninvasive Ventilator

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RoHS

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Ingress protection

Warnings

● Before using this instrument, please read the manual carefully.

● Do not use this instrument for life support.

● The instrument produces a positive airway pressure when it outputs the gas, andif positive airway
pressure has side effects to the patients, it must be considered tohandle.

● This instrument must be used and set parameters under guidance of professionaldoctors.

● Do not replace doctor's advice with recommends in the manual.

● This instrument can only use water chamber, Heated breathing tube, nasal cannulasand other
accessories provided by RMS Medical. Use of unapproved accessories may affect the functionality
of the instrument or cause a danger.

● The water chamber, Heated breathing tube,nasal cannula and other accessoriesprovided by our
instrument,it can only be used for this instrument, otherwise it mayaffect the function of other
equipments or cause danger.

● In case of power failure or machine malfunction, remove the nasal cannulas andclose the oxygen
input.

● To ensure its electromagnetic compatibility, this instrument must be installed,debugged and used
according to provisions in attached documents.

● Portable and mobile RF communication equipment may affect this instrument'selectromagnetic
compatibility. In case of such event, please contact our staff forsolutions.

● This instrument can only be connected using cables mentioned in the attacheddocument. Use of
unapproved accessories and cables for connecting theinstrument may result in increased emission
or reduced immunity.

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● Do not place this instrument near to or stacked with other equipment. If it is necessary to place this instrument
near to or stacked with other equipment, inspection and observation must be conducted to ensure that it can
operate normally in such location.The instrument should be placed in a well-ventilated area and not on the soft
surface.

● Do not use the instrument when it is surrounded by flammable and/or anesthetic gases.

● Stop using the instrument if it has visible external damage, a liquid has entered into the instrument or the outlet
gas is over-temperature or there is abnormal noise.

● The over-use of Heated breathing tubeand nasal cannula can cause infections and other injuries.

● When the instrument is used under specified ambient temperature and humidity conditions, the temperature of
outlet gas isless than 43℃.。

● In ventilation mode, the outlet gas may be harmful to the human body, when the room temperature exceeds 35°C.

● In humidification mode, the temperature and humidity will be affected when the ambient temperature exceeds
the specified temperature range of 18 ° C ~ 28 ° C.

● When the instrument is used beyond the specified ambient conditions (temperature, humidity etc.), the instrument
performance will be affected and even damaged and may cause body injuries.

● When the atmospheric pressure exceeds the specified range, using the ventilator may cause the set pressure to
differ from the actual pressure

● AC input should be within ±10% of the rated voltage. AC input beyond this range may cause damage to the
instrument.

● When exposed in an environment of electrocautery, electrosurgery, defibrillation, X-rays (γ-rays), infrared radiation
andtransient electromagnetic fields, including magnetic resonance (MRI) and radio interference, the instrument
may be interfered.

● When the instrument is blocking, covering or heating the outlet tube,air inlet port may cause overheating or even
damage to the instrument.

● When the instrument is connected to oxygen,it may cause higher output oxygen concentration if the output tube
is blocked.

● The ventilation holes are at the bottom of the water chamber. When moving the humidifier, do not touch the
bottom to prevent body injuries.

● Pressure and differential pressure sensors are installed inside the device. Pay attention to prevent water from

flowing backwards and causing damage.

● Do not move the instrument, place it upside down or tilt it when there is water in the humidification cup, so as to

prevent water from flowing back into the instrument which will cause damages to the instrument. Above the
humidification cup, label awarning label “Do not Tilt the Instrument When There is Water!” to have attentions.

● When the instrument is not in use, pull the plug.

● Do not open the inside of instrument,should be repaired by the authorized maintainer.

● When the treatment instrument is beyond its service life, please contact your dealer or RMS Medical for
disposition instead of discarding it arbitrarily.

● Adding other components to the respiratory ventilation system will cause the exhalation pressure at the
connection port of the patient to increase.

● Do not use antistatic or conductive hoses or tubes.

● The sensor's raw data collected by the ventilator is anti-interference processed by the median average filtering
method.

● The high-pressure gas must be connected to medical oxygen, and fresh gas cannot be used.

● It is recommended to measure the oxygen concentration at the patient's delivery end.

● The nasal cannula, Heated breathing tube, water chamber, mask, etc. equipped with the ventilator are products
registered separately by manufacturers with medical device qualifications. When using them, please refer to their
own instructions.

● Note:Above mentioned are general warnings and precautions.Detailed special warnings,notes and remarks are
shown in the manual.

Preface

BPAP H series ventilator is a breathing ventilation device that can use both non-invasivemask ventilation
and high-flow humidified airflow. Please read and understand thismanual carefully before use.

The non-invasive ventilator must be set and used for treatment parameters under theguidance of a
professional doctor.

Medical information

This product's non-invasive positive pressure ventilation mode (Ventilation mode for short) can be used
for adult patients with insufficiency of breathing, such as those who do not rely on invasive ventilation
support, to provide ventilation assistance and respiratory support; has a high-flow heating and
humidification mode (high flow mode for short) The product can be usedfor humidification and oxygen
therapy in adults with spontaneous breathing.

This product is not intended for life support, can be used in home environments, and can also be used in
medical institutions. This product needs to be used under the guidance of a professional doctor.

★ Heartbeat or breathing stops;
★ Weak spontaneous breathing and coma;
★ High risk of aspiration, inability to remove oropharyngeal and upper respiratory secretions,and poor

respiratory protection;

★ Combined with other organ failure (unstable hemodynamic indicators, unstable arrhythmia,perforation
/ hemorrhage of digestive tract, severe brain disease, etc.)

★ Undrained pneumothorax;
★ Neck and facial trauma, burns and deformities;
★ Recent face, neck, oral cavity, pharyngeal cavity, esophagus and stomach surgery;
★ upper airway obstruction;
★ Obviously uncooperative or extremely nervous;
★ Severe hypoxemia (PaO2 <45mmHg), severe acidosis (pH ≤7.20);
★ severe infection;
★ Airway secretions or sputum disorders;
★ Not recommended by other clinicians.

Note: It is a relative contraindication. In such patients, the pros and cons of NPPV (non-invasivepositive
pressure ventilation) need to be carefully weighed, then decide whether to apply NPPV;

->Adverse reactions

If the patient has abnormal chest pain, dyspnea or severe headache or other adverse reactions,please
contact the clinician immediately.

During the use of the ventilator, the following adverse reactions may occur:

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Instrument Information

->Instrument Components

Instrument.Water chamber.Heated breathing tube.mask or nasal cannula. The instrument

->Components and Functions

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BPAP H

/

Display screen

Buttons

High Pressure Oxygen Inlet

Oxygen Inlet

Power Port

Water Chamber

Water Chamber - for dew poit and

reference point of temperature

->Connect the water bag

Hang sterile water bag onto the instrument's high position whenuse the Water
chamber, insert the inlet needle into the rubber plug of water bag, and open the

bag's vents. The Water chamber will be added with water automaticallyaccording
to a fixed level.

->Warnings:

Please use a medical treatment and no more than 2000ml of sterilized water.

After connecting into the water bag, check whether the water is flowing into the

Water chamberand kept below the water line. In case of any problem, replace

the Water chamber.

Make sure water in the Water chamber and water bag will not run out during

use. Otherwise it will cause the Water chamber to run dry and affect the

humidification effect.

When the Water chamber run dry,please replace Water chamber to avoid

Water chamberdamage.

->Connect the heating tubes

In Ventilation mode: Connect the mask, Heated breathing tube
and gas outlet of the ventilator.
In High Flow mode: Connect the nasal cannula, Water chamber

and Heated breathing tube to the gas outlet of the ventilator.

->Warnings:

Please check the Heated breathing tube before connection. If it is damaged or bent, please replace the Heated
breathing tube.The human body should not be in contact with the Heated breathing tube for a long time,

otherwise it may cause danger or personal injury.

The Heated breathing tube should not be close to any heating body, and should not cover anything,
otherwise it may cause danger or personal injury.

The Heated breathing tube should be kept away from all kinds of objects with electronic radiation, as
well as

various wires and wires to prevent interference.

->Connect to the oxygen source

Ventilator can be connected to external oxygen to max flow 80L/min, but not to over current flow.

Connect the outlet of oxygen source tothe inlet port of device, ensure the proper assembly.

System Assembly

! Warnings: when the Water chamber and Heated breathing tube are not installed well, do not open
the

－＞Fill Water chamber

★ Depress the hand guard to insert the Water chamber into the instrument,
making it closely connected tothe instrument's interfaces, and then, the
hand guardis rebounded back into place.

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BPAP HF/BPAP HE/BPAP HO BPAP HP/BPAP H

->Connect to the power

Connect the power adapter to the power port on the back of the
instrument and then, insert the AC connector into the AC socket.
The instrument's screen lights up, which means it is powered properly.

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