General description
1.1 Application Scope and Main Features
New Bright A6 anesthesia machine is necessary anesthesia equipment in the surgical room, whose main function is to provide O2 for the patients, and help them to inhale anesthetic and manage the respiration.This product is suitable for the inspiration anesthesia of patients and the respiratory management in a surgery. This product is suitable for children of more than 4 years old and adults; there is no absolute contraindications but the relative contraindications which are as fallows: patients with pneumothorax and mediastinal emphysema and those who are not operated a chest drainage, and those who suffer severe pulmonary hemorrhage, bullae of lung, hypovolemic shock, acute myocardial infarction.
New Bright A6 anesthesia machine is equipped with precise specified anesthesia evaporator, safety device which can avoid anoxic, and also necessary alarm system. During the process of anesthesia, pneumatic and electronic motion control anesthesia ventilator controlled by microcomputer can manage the patients’ respiration. All the connecting parts employ standard interfaces . Efficient and big soda lime absorber can reduce the repeated inspiration maximatily at large.
1.2 Working Environment
The New Bright A6 anesthesia machine belongs to the Class I internal power supply B-type application part of general medical equipment defined in GB 9706.1-2020 "Medical electrical equipment - Part 1: General requirements for basic safety and basic performance"
:this is the symbol to represent Type B application device.
The machine is normal equipment which is IPX0, but It can work continuously.
The machine is not explosion-proof equipment, so please DO NOT operate the machine in the circumstance with explosive or flammable gases.
The environment of normal using and the test conditions of working:
—— Environment Temperature:10 ～ 40 ℃ ;
—— Relative Humidity:≤80 % ;
—— Atmospheric Pressure:96kPa ～ 104kPa;
—— Gas Supply:O2: Range of pressure input: 280kPa～600kPa,rated pressure 400kPa;
N2O:Range of pressure input: 280kPa～600kPa,rated pressure 400kPa ;
—— Power Supply: AC 220 V,50Hz Single phase AC power supply with good protective grounding.
Power input:100 VA
——Specification of Fuses: The section of network power: RF1-20 F2AL250V;
Emergency battery:5RF/ F5AL250V.
——Specification of Emergency battery:DC14.8V-2.2AH
1.3 Electromagnetic compatibility requirements
This anesthesia ventilator should not be used in the environment with strong radiation and strong electromagnetic interference, e.g. MRI. Otherwise, the performance of the device will be influenced adversely in various degree.
2 Structure Feature and Working Principle
The anesthesia machine consists of rack, flow meters, anesthesia evaporator, anesthesia breathing circuit and AV-2000A ventilator.
2.1 Main Unit
The anesthesia machine uses compressed O2, N2O(Nitrous Oxide gas) which come from gas cylinder or central gas system in the hospital. In order to ensure the safe use of the machine, the machine is also equipped with backup O2 source interface. Pressure of all the gases should be 280kPa～600kPa. There are filters at the entrance of the gas source in order to prevent bigger than100μm entering into the working system of the machine.
The gas source inlet pipeline joint of anesthesia machine are dedicated to the same kind of gas and are not interchangeable, which can prevent the wrong gas connection. The various gas source nozzles and gas source pipes are all marked with corresponding logos. The oxygen pipe is marked with “O2”, the nitrous oxide pipe is marked with “N2O”, and the air pipe is marked with “Air”.
After compressed O2 enters into the machine, O2 and N2O mixed into one gas which will be divided into five gases. The first gas is connected to the pressure monitoring device to monitor the input gas supply pressure. The second will lead to the fresh gas outlet after being connected to the fast oxygen supply valve; the third enters into the flow meter after being decompressed again;the fourth will be connected to the anesthesia ventilator, and will become the driving gas of the ventilator;the fifth is connected to the safety valve (exhaust pressure greater than 600kPa) to prevent danger caused by excessive output pressure when customers use medical gas pipeline systems for ventilation.
After the compressed nitrous oxide enters into the anesthesia machine, it will respectively be decompressed again and then will enter into the flow meter,the other way is connected to the safety valve (with an exhaust pressure greater than 600kPa) to prevent the customer from using the medical gas pipeline system for ventilation, which may cause danger due to excessive output pressure.
The flow meter adjusts all the gases and transports the mixed gas to the anesthesia evaporator, and then the mixed gases, together with anesthetic will be sent to the anesthesia breathing circuit by fresh gas outlet.The other route is transported to ACGO, while only one route is ventilated.
A pressure adjuster must be used when using cylinder. The output pressure should be 400KPa. The pressure adjuster can ensure the stability of the output pressure when inlet pressure is 1000kpa and the pressure from the output port is not more than 8kpa.There is safety valve on the output end of the adjuster, if there is malfunction or if the output pressure is too high because of man-made reason, the safety valve will exhaust gas automatically to make the output pressure reach rated value. The exhaust pressure of the safety valve is no less than twice as much as the rated input pressure.
2.2 Anesthesia breathing circuit
Anesthesia breathing circuit, is a kind of gas path device connected to the patients. The main function is to deliver the anesthesia mixed gas to the patient, and meanwhile, the patient can complete regular respiration like inhaling oxygen and exhaling CO2 via it. It has two modes: Auto and Manual. In auto mode, the patients’ respiration is controlled by the machine; while In the manual mode, the patients’ respiration is controlled by doctor through the way of pressing leather bag that connected to the circuit.
2.3 Anesthesia Ventilator
The anesthesia ventilator uses AV-2000A gas driving and Electrical control ventilator
Driving anesthesia ventilator working pressure is 300kPa, flow ≤ 200L/min.
The oxygen which drives the anesthesia ventilator will form a certain volume of gas through flow regulating valve, which passes the ventilation circuit to drive the movement of the folding bag ,thus doing mechanical ventilation to patients. The maximum Anesthesia ventilator inspiratory flow ≤ 60L/min, maximum pressure ≤ 6kPa.
The anesthesia ventilator adopts high-speed electromagnetic valve, high sensitivity flow sensor, pressure sensor and single-chip control system and it can work stably 10s after turning it on. The ventilator could ventilate patient mechanically according to the set frequency, I/E ratio and tidal volume when the anesthetic takes effect and patients lose conscience to breathe themselves; the anesthesia ventilator will be together with patients’ synchronous breathing when the patient has conscience to breathe himself after operation.
If anesthetic breathing circuit stays in “manual control” state, the anesthesia ventilator could also monitor and show the tidal volume, ventilation frequency and airway pressure etc. Although it doesn’t take part in the role of breathing control.
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