CE certification YH830 CPAP Bi-level with independent humidifier non-invasive ventilator

Product DescriptionSpecification
Product Name :
YH-830 MOBILE VENTILATORS BI-LEVEL
Weight:
1500g
Operating temp:
5-35℃
Relative Humidity:
10%-90%
Mode:
CPAP, S, T, ST
VGPS Pressure:
4-30 cm H2O
Adjustments:
Trigger, Cycle, Sloop
Power Supply:
Input: AC 100-240V, 50-60 Hz, 1.8A MaxOutput: DC 24V, 3.33A
Packing & Delivery
Package
One carton Package
Packing: Each carton contains 1set machine
Package Size :1 PCS/CTN48.5×32.5×21.5cm
N.W.(kg):1.6
G.W.(kg):4.4


Loading and delivery
Land transport
Air transport
Express
Ocean shipping

FAQ
1.What is a ventilator, and what does it do?
* During the Wuhan epidemic, China provided more than 14,000 non-invasive ventilators, of which 60% were from yuwell. There are
mainly three models of YH-730, YH-830, and YH-830 mobile , yuwell Breathcare products is bilevel devices, the difference isunder.
* • Noninvasive ventilation (NIV) is a form of mechanical ventilation where air is delivered to the patient through a mask or
mouthpiece.
* • Invasive ventilation is used when sufficient ventilation cannot be achieved using non-invasive methods; air is delivered
through a tube inserted into the trachea either by intubation or tracheotomy.
* • Bilevel devices are non-invasive only and deliver two distinct pressures, one for inhalation and the second for exhalation;
the change in pressures leads to flow of air in and out of the lungs.2. Can yuwell bilevel device treat COVID-19?
* • Yes, according to the US FDA official website March 24 EUA guidelines for ventilator
* Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act are met, I am authorizing
the emergency use of ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing
devices modified for use as ventilators (collectively referred to as “ventilators”), ventilator tubing connectors, and
ventilator accessories4 that FDA determines meet the criteria for safety, performance and labeling set forth in Section II and
Appendix A for emergency use in healthcare settings to treat patients during the COVID-19 pandemic, contingent upon submission
of a request from the sponsor of a ventilator, ventilator tubing connector, or ventilator accessory as described in Section II
and pursuant to the Conditions of Authorization in Section IV of this letter. Ventilators, ventilator tubing connectors, and
ventilator accessories that have been authorized will be added to this letter of authorization in Appendix B (referred to in
this letter as “authorized ventilators, ventilator tubing connectors, and ventilator accessories”).
3. How does Yuwell bilevel enter clinical settings？
* • On the standby page, press and hold the start button and the knob at the same time to enter the clinical menu interface toadjust the parameters, and also in the treatment interface, press the start button and the knob at the same time to enter the
parameter setting interface to adjust the parameters.4. How to set clinical parameters?* • Depending on the situation of different patients, we recommend clinicians to set it up, we cannot give clinical opinions.


5.How about the productivity of your factory and how long you can deliver？
*about 15 days for 1-500 units, about 25 days for 1000 units