1. Introduction
1.1 Intended use
The BIPAP is Bi-level continuous positive airway pressure device that mainly used for home care and clinical treatment of obstructive sleep apnea-hypopnea syndrome (OSAHS) or respiratory insufficiency.
This device is to be used only under the instruction of a licensed health care professional. Your home care provider will make the correct pressure settings according to your health care professional's prescription. The device can deliver CPAP or Bi-level therapy. In Bi-level, you can set both the IPAP (inspiratory positive airway pressure) and the EPAP (expiratory positive airway pressure).
The humidifier cooperates with the host to provide the user with a air of suitable temperature and humidity to avoid drying of user's nasal mucosa and make comfort treatment. The host controls the humidifier's turning on/off, the principle of which is to heat the water in the chamber and make the air inhaled by the user with suitable temperature and humidity.
1.2 Application
BIPAP is applicable to the clinical treatment of adult OSAHS patients. It does not apply to children or the users that can not safely use on physical, sensory and intellectual without auxiliary and supervision.
1.3 Warnings & Cautions and Contraindications
1.3.1 Warnings
Warnings indicate the possibility of injury to the user or the operator. please read it carefully before using it.
The Instructions is for reference. It cannot supersede the professional medical's guidance for the use of the device. This device is not intended for life support.
This device may be influenced or disturbed under below environment:
The electromagnetic fields exceed 3V/m under the EN60601-1-2 test conditions.
Operation of high frequency device (diathermy).
(Electric shock) defibrillator, or short-wave therapeutic device.
Radiation (Such as x-ray, CT).
Electromagnetic field (Such as MRI).
Use Beyond circuit accessories or the accessories recommended by medical Professional.
Do not wear the mask and headgear for more than a few minutes while the device is not operating.
Keep the device dry, the tubing and mask smooth.
If you notice any damager of the device or any unexplained performances such as unusual harsh sounds, please disconnect the power supply, empty the water in the chamber and stop using the device. Then you can contact your home care provider or the manufacturer.
CPAP devices have the potential to allow rebreathing of exhaled air.
To reduce this potential, observe the following:
- Use Beyond circuit accessories.
- Do not wear the mask and headgear for more than a few minutes while the device is not operating.
- Do not block or try to seal the vent holes in the exhalation port.
This device is not recommend to use with the oxygen , Sources of oxygen must be located more than1 m from the equipment to avoid fire hazard.
Do not operate this device in the presence of a flammable anaesthetic mixture in combination with oxygen or air, or in the presence of nitrous oxide.
Keep away from toxic or hazardous steam.
Do not use this device if the room temperature is higher than 35 ºC, otherwise the temperature of the air flow may exceed 41ºC,this is could cause your airway damage.
Do not use this device under direct sunlight or near to heating equipment, otherwise the temperature of the output will increase.
To avoid electrical shock, disconnect the power cord before cleaning. DO NOT immerse the device in any fluids.
Contact your health care professional if symptoms of sleep apnea recur.
Check power cable and accessories regularly.
Disconnect the power supply before checking the device.
When using this device make sure the position of the mask is higher than the host, otherwise the condensed water in the tubing may flow into the user's nose which cause suffocation.
Stop using this device if the humidifier is damaged.
Do not touch the heater plate before it cools down after disconnecting the power supply.
Do not add water with a temperature above 35ºC.
Do not splash the water into the device when installing the water chamber.
Do keep the device can't be touched by children, to avoid stranglehold or asphyxia by the tube.
Appliance coupler is considered as disconnect device, please do not place the equipment in a difficultly operation position.
Do not modify this equipment without authorization of the manufacture.
Do not position next to a curtain that blocks the flow of cooling air, thereby causing the equipment to overheat.
Do not block the gas INTAKE PORT, thereby interfering with therapy.
The proper placement and positioning of the MASK on the face is critical to the consistent operation of this equipment.
1.3.2 Cautions
Cautions indicate it may damage the device,please read it carefully.
Do not wear the mask until the device is running normally.
Do not operate the device beyond the range of non-operating temperature. If the device was exposed at a too-high or too-low temperature previously, make it return to the room temperature before use.
Do not immerse the device in any liquid, or let any liquid enter into the device or the filter at the air inlet.
The condensated water may damage the device. Make sure the device reach the room temperature before use.
A properly good fitted filter is required during the normalrunning.
The tar generated by smoking gathering on the device shell will lead to device failure.
If any liquid splashes on the heater plate, disconnect the power supply,use it until it get completely dry.
Take preventive measures to avoid device damages due to water.
Only the distilled or pure water can be used in the water chamber. Other liquid may damage the humidifier and device, even endanger the user.
Do not exceed the maximum water level marked on the water chamber.
Do not splash the water into the device when installing the water chamber.
Do not tilt the device to avoid the water flowing back into the device. If it happens, please disconnect the power and stop using it.
1.3.3 Contraindications
Clinicians should know the device can provide a pressure up to 25cmH2O, when evaluating relative risks and benefits of using the device. In case of any single fault, the max pressure should not be more than 30cm H20. Studies have shown that some patients with the following circumstances may not be suitable for the treatment of this
device.
Bullous lung disease
Pneumothorax
Pneumomediastinum
Serious lack of effective circulating blood volume with shock
The one in a coma or disturbance of consciousness and unable to cooperate with or accept the mask treatment
Lots of respiratory secretions and coughing, weak breathing independently
Pathological hypotension
Pneumothorax when using nasal continuous positive airway pressure.
Be careful when making prescriptions for the following susceptible patients with the treatment of the Sleep Apnoea Breathing Therapy Equipment: cerebrospinal fluid (CSF) leakage, cribriform plate malformation, brain trauma history and / or pneumothorax. (Chest 1989;96:1425-1426)
Those with symptoms of sinusitis or otitis media is not suitable to adopt the positive airway pressure therapy. The patient with upper airway obstruction and the alcoholics is also not suitable to adopt the positive airway pressure therapy. In case of any questions about the treatment, please contact your doctor.
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