Comen AX400 Anesthesia Machine – Use as Invasive Ventilator
Anesthesia machine used as ventilator for the treatment of respiratory failure caused by COVID-19
As we continue to respond to medical supply demands from around the world, we observed an unprecedented demand and shortage of ICU ventilators. As the supply chain of ventilators is spread out in different countries, many manufacturers have expressed concern that they are not able to provide continuous production. To mitigate the supply shortage of ventilators, the U.S. FDA has issued a guideline that suggests anesthesia gas machines can be used if ICU ventilators are not available.
Solution
Anesthesia machine, also known as anesthesia ventilator, integrates anesthesia evaporation system and ventilator system to help patients "mechanically control breathing under general anesthesia. It is essentially a "ventilator with anesthesia function". However, compared to the ventilator, the anesthesia machine is equipped with breathing monitoring and anesthesia detection; it has a more complex structure and more diverse functions, which requires higher technical skills of anesthesiologist.
COVID-19 broke out globally and there was a serious shortage of ventilator. The US FDA advocates
using anesthesia machines as ventilators to relieve medical pressure, which has been clinically verified and approved in many countries. The following is our plan to use the anesthesia machine as ventilator.
When an anesthesia machine is used as a ventilator, the ventilator tube (with a condensate bottle) is used to connect the patient. It is necessary to connect abacterial filter device on the exhalation and inhalation sides of the anesthesia machine and a humidifier on the inhalation side. To prevent repeated absorption of carbon dioxide, soda lime needs to be replaced regularly.
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The UK set up field hospitals
source: https://www.iqiyi.com/v_19rwn8hsn4.html
Makeshift field hospital set up in New York also prepared anesthesia machine.
source: https://new.qq.com/omn/20200406/20200406A0PT3800.html
USE CASES
According to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia(Trial Version 7), respiratory support is needed for patients with severe and critical symptoms.
Ventilation mode that is also available on anesthesia machines
HFNC solution
1、Precise and Reliable Ventilator
- Digital flow valve and precise dual flow sensing technology, more accurate control, faster response
- SIMV/ SIMV + PS help simplify the work of caring for spontaneous breathing patients when weaning
- Advanced PSV Ventilation (with apnea backup) make patients with spontaneous breathing more comfortable
- PRVC mode, gives you the best of both worlds: the benefits of pressure controlled ventilation and
- a consistent tidal volume. More suitable for laparoscopic, thoracoscopic and patients with lung compliance changes
- Automatic compensation maintain accurate tidal volumes, and ensure that what you set is what you get
Comprehensive respiratory mechanical parameters monitor, real-time waveforms display, optimizing clinical decision
- Electronic PEEP function
2、Excellent Breathing Circuit
- High integration, small and compact design,
- greatly reduces the potential for leaks and misconnects
- Material: PPSU, fully autoclavable at 134°C and nature latex free
- By-pass function, available for canister exchange during surgeries
- Easy removal-no tools required,convenient for clean and maintenance
- One hand installation to CO 2 canister, fast and healthy
- Faster response-ideal for low flow anesthesia
3、Modular Design
- BIS / AG / CO 2 module optional
- Automatically identify CO 2 , N 2 O and 5 Anesthetic Gases
- Support CO 2 , N 2 O, anesthesia gas waveform display, support MAC value display
- Monitoring modules can be shared with our modular monitor, cost effective
- Support real-time O 2 concentration monitoring
- BIS value display and EEG waveform display once plug in the BIS module
- Sample gas conncet with AGSS port design
4、Mechanical Flowmete
- Individual flow controls with dual flow tubes providesimple, precise control, facilitate easy and accurateminimal / low flow anesthesia
- 3 gas with 6 tubes flowmeter optiona
5、AGSS, Effective Removal of Anesthesia Gas from the Working Area (Optional)
- We know anesthetic gas is harmful to us, e.g. causing nausea,dizziness, headaches, fatigue, and irritability, as well as sterility,miscarriages, birth defects, cancer, liver and kidney disease
- Anesthesia waste gas in the operating room is always plaguingthe construction of laminar flow operating room
- In order to better protect the health of workers and solve thepollution in the laminar flow operating room, Comen adopts theleading technology in this field and has developed a closed-type active scavenging system, and solve your worries
6、Clear and Intuitive User Interface
- Large touch control screen design
- The setting and measured value of ventilation displayed on the same screen helps make the management of gas delivery more safe and effective
- Comprehensive monitoring, multi-selectable displays, e.g. 4 waveforms, anesthesia gas monitoring and big font display
- 2000 event records of settings, technical and physiologic alarm
- Intelligent alarm management
Product Certificate
Due to the short market supply, manufacturing capacity and bottleneck, please contact us for current ventilator products availability, specs, and pricing. Please note, price and availabilities change each day, consult our team for the most recent updates.
References: Additional FDA EUA announcements
FDA Policy for Modifications to FDA-Cleared Devices: FDA does not intend to object to limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.815 , for the duration of the declared public health emergency.
Modifications to FDA-Cleared Indications, Claims, or Functionality: For the duration of the public health emergency, to help foster the wider availability of devices for patients in need of ventilatory support, FDA does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of these devices, without prior submission of a premarket notification where the modification will not create an undue risk in light of the public health emergency.
“I am waiving the following requirements for authorized ventilators, ventilator tubing connectors, and ventilator accessories during the duration of this EUA:
- Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the authorized ventilators, ventilator tubing connectors, and ventilator accessories listed in Appendix B that are used in accordance with this EUA; and
- Registration and listing requirements, including the requirements under 21 CFR Part 807.”
*Additional information may be found at: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff, March 22 2020, URL: https://www.fda.gov/media/136318/download ; March 24, URL: https://www.fda.gov/media/136423/download
*FDA would find it helpful if such manufacturers (whether foreign or domestic) send FDA the following information to [email protected]; FDA believes this information will be valuable in assessing whether the device would be able to meet the EUA requirements.
