Specification: AX400

SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD

No.2 of FIYATA Timepiece Building, Nanhuan Avenue, Gongming
sub-district, Guangming New District, Shenzhen, P.R. China
Tel: +86-755-26408879
Fax:+86-755-26431232
Email: [email protected]
Web: www.comen.com

2021 V 2.2
 Anesthesia Machine
AX400

Technical Specification supporting capacity 20kg

Physical Characteristics Operational
Size 773.5mm×1380mm×598mm dimensions 465mm×275mm
Weight 90kg Dimensions with
Entire Machine Additional Accessory 472mm×248mm×380mm
Maximum Bearing Interface:
Weight 160kg USB port
Screen Size: 8.4” TFT touch screen RJ45
Resolution 800 × 600 3 auxiliary power output
Handrail Length 412mm AC power interface
Caster wheel 4 wheels 5” brakes; Equal-potential grounding
Optional module slot 1 terminal
number DB9 interface
Operation Environment
Features
Working Temp 10~40°C
Drawers: Size: 416mm×395mm×170mm
Humidity ≤93%
Bearing Weight: 1Kg
Power Supply 100-240V~, 50/60Hz±1Hz
Gas-bag Sway Brace: Length: 320mm; Height: 240mm
Battery Type Rechargeable Lithium-ion battery
Anesthesia process Open, semi closed, closed circuit
Battery Capacity 4400mAh, 11.1VDC
Patients Adult, pediatric
Battery Recharging
Mode Manual, Mechanical, Standby
Time 4 hours for charging
Compliance Compliance Correction
Battery backup 2 hours for continuous working
Configuration Possibility of configuration
Trace Waveforms: Pressure-time; Flow
observation
rate-time; Capacity-time; ET
Optional Bypass; Heating; Oxygen sensor;
EtCO2 concentration
ACGO; AGSS; BIS; CPB;
Optional: Pressure-volume Loops;
MASIMO EtCO2 (sidestream);
Flow-volume Loops; Pressure- flow
MASIMO EtCO2 (mainstream);
Loops
MASIMO AG (sidestream);
Top Plate
Respironics EtCO2 (mainstream);
Maximum supporting
capacity 50kg
Ventilator Specification
Operational
Ventilation Modes
dimensions 535mm×235mm
VCV/VC Volume-Controlled Ventilation with
Dimensions with
tidal volume compensation
Additional Accessory 508mm×313mm×380mm
Others Manual and automatic ventilation
Workbench
Maximum
Optional PCV/VPC, SIMV-VC, PSV/ CPAP, Ventilator Monitoring Ranges
SIMV-PC, PRVC, SIMV-PRVC, PSVPro TV (Inspiratory tidal
Ventilation principle Chronometric, volumetric and volume) 0~3000 mL
barometric TV (Expiratory tidal
Ventilation Electronically controlled& volume) 0~3000 mL
pneumatically driven MV (Per-minute
Driven gas O2(air: optional) ventilation amount) 0~100 L/min
Breathing circuit FiO2 (Oxygen
volume 1000 ml + bag concentration) 18~100%
Ventilator Setting ranges Airway pressure -20~120cmH2O
Monitoring Tidal volume, Inspiratory, expiratory PEEP 0~70cmH2O
parameter flow, minute volume, frequency, Ppeak
pressure (Pmean, Pplat, Ppeak, (Airway pressure) -20~120 cmH2O
PEEP), Oxygen, CO2, N2O and Pmean
halogenated expiratory (Mean pressure) -20~120cmH2O
concentration, Pressure, oxygen, Pplat
CO2, N2O and Halogen numerical (Platform pressure) 0~120cmH2O
values, compliance and patient I: E (Inspiratory-
resistance expiratory ratio) 4:1~1:12
Tidal volume range 15 ~1500 mL Freq
MV (Per-minute (Respiratory rate) 0~120 bpm
ventilation amount) 0~100 L/min Compl (Compliance) 0~300 mL/cmH2O
Pressure range Resistance 0~600 cmH2O/(s/L)
(limit) 10~100 cmH2O EtCO2
Pressure range MASIMO EtCO2 0~190mmHg, 0~25% (at 760mmHg)
(support) 3~60cmH2O (sidestream); Accuracy: ± (0.3KPa+4% of
Respiratory rate 4~100bpm MASIMO EtCO2 reading). 0~190mmHg, 0~25% (at
Inspiratory (mainstream) 760mmHg) Accuracy: ± (0.3%KPa
/Expiratory ratio Respironics EtCO2 +4% of reading). 0~150mmHg,
(I: E) range 4:1~1:10 (mainstream) 0~19.7% (at 760mmHg)
Apnea I: E 4:1~1:8 Accuracy: 0~5.3%: ±0.3%.
Apnea time 10~30s 5.4~9.2%: ±5% of reading.
Apnea pressure 3~60cmH2O 9.3~13.2%: ±8% of reading.
Freq. Min. (Min. 13.3~19.7%: ±10% of reading;
frequency for apnea- 2-60 bpm NMT
ventilation) stimulus output Pulse Width: 200us;
Inspiratory pause OFF, 5~60% of inspiratory time accuracy: ±10%;
Inspiratory time 0.2~5s Stimulate current range:
Inspiratory pressure 5~70cmH2O 0mA~80mA; Step size 5mA;
PEEP OFF, 3~30cmH2O Accuracy: ±5% or ±2mA( whichever
Trigger pressure -20~-1cmH2O is greater)
Trigger window 5~90% Maximum skin impedance: 5KΩ
Trigger flow 0.2~15 L/ min ST mode ST-Ratio: 0%~200%;
Flush oxygen 25~75 L/ min Measurement interval: manual, 1s,
Inspiratory stop level 5~80% 10s, 20s, 30s
Pressure slope 0~2.0s TOF mode TOF-Count:0~4
 TOF-Ratio: 0%~200% Pressure range at 0.28~0.6 MPa
TOF-T1%:0%~150% inlet
Measurement interval: Manual, Peak gas flow >100 L/min
12s, 15s, 20s, 30s, 1min, 2min, Flow valve range 3~100 L/min
5min, 10min, 15min, 30min, 60min Flow compensation
PTC mode PTC-Count: 0~20; Measurement range 200 mL/min to 18 L/min
interval: Manual; Inspiratory flow Maximum inspiratory flow shall not
DBS mode be smaller than 120L/min when gas
DBS-Count: 0~2; supply pressure is 280KPa.
DBS-Ratio: 0~200%; Range of flow valve 3~100 L/min
Measurement interval: Manual, Pressure limitation Controlled by the electronic relief
15s, 20s, 30s, 1min, 2min, 5min, Controlling means for valve fitted inside the ventilator.
10min, 15min, 30min, 60min ventilator Controlled by the mechanical relief
TET mode Physiological rigidity mode, valve fitted inside the ventilator.
provides 50Hz and 0.2ms pulse
stimulation Ventilator accuracy
Block recovery Off、1、2、3、4、5%、10%、 Control accuracy
20%、30%、40%、50%、60%、 TV 15~60 ml: ±10ml.
70%、80%、90%、100%
60~210 ml: ±15ml.
AG 210~1500 ml: ±7% of set value.
MASIMO AG SEV: 0~25% PCV Inspiratory pressure: ±2.5cmH2O or
DES: 0~25%
±7% of set value, whichever the
HAL/ ISO/ ENF: 0~25%
greater.
N2O: 0~100%
Limiting pressure: ±2.5cmH2O or
O2: 0~100%
±7% of set value, whichever the
CO2: 0~25% (0~190mmHg)
greater.
Accuracy:
PEEP: OFF: undefined; 3~30cmH2O:
SEV: 0~1%: ± 0.15%; 1~5%: ±0.2%;
±2.0cmH2O, or ±8% of set value,
5~8%: ±0.4%;
whichever is the greater.
DES: 0~1%: ± 0.15%; 1~5%: ±0.2%;
Supporting pressure: ±2.5cmH2O or
5~10%: ±0.4%;10~15%: ± 0.6%;
±7% of set value, whichever the
15~18%: ±1%;
greater.
ISO, ENF, HAL: 0~1%: ±0.15%;
Apnea pressure: ±2.5cmH2O or ±7%
1~5vol %: ±0.2%;
of set value, whichever the greater.
N2O: ± (2% + 2% of the reading)
Trigger pressure: ±2.0cmH2O.
O2: 0~25%: ±1%; 25~80%: ±2%;
Freq ±1 bpm or ±5% of set value,
80~100%: ±3%;
whichever is the greater.
CO2: 0~15%: ± (0.2% + 2% of the
I: E 2: 1~1: 4: ±10% of reading value;
reading); 15~25%: unspecified
Other ranges: ±25% of reading
Anesthesia depth value.
BIS 0.0~100.0
Apnea I: E 2: 1~1: 4: ±10% of set value;
SQI 0.0~100.0%
Other ranges: ±25% of set value.
EMG 0~100dB
Tpause In the range of 20%~60%: ±15% of
ESR 0.0~100.0%
set value;
Ventilator Performance
Other ranges: undefined.
Inspiratory time ±0.2s MV 0 L/min~30 L/min: ±1 L/min or
Inspiratory pause 20%~60%: ±15% of set value; ±15% of set value, whichever is
Other ranges: undefined. greater; Others: undefined.
Trigger window ±10% Compliance 0 ml/cmH2O~250 ml/cmH2O: ±0.5
Trigger flow rate ±1 L/ min ml/cmH2O or ± 15% of reading
Inspiratory stop level ±10% value, whichever is greater.
O2/ N2O/ Air flow 10~100% of the full scale: ±10% of Other ranges: undefined.
control the reading value. Other ranges: Resistance 0 cmH2O/(L/s)~20 cmH2O/(L/s): ±
undefined. 10 cmH2O/(L/s)；20
Total flow control Air balance gas: ≤±3% cmH2O/(L/s)~500 cmH2O/(L/s)：±
N2O balance gas: ≤±3% 50% of reading value; Other ranges:
Backup flow control Pure Oxygen flow rate is 0~10 undefined.
L/min: ≤±3%; Others: undefined. Oxygen sensor ±3%
Auxiliary flow control 10~100% of the full scale: ±10% of O2/ N2O/ Air flow 10~100% of the full scale: ±10% of
the reading value. Other ranges: control the reading value. Other ranges:
undefined. undefined.
Monitoring accuracy Total flow control Air balance gas: ≤±3%
TV 0~60ml: ±10 ml; 60ml ~ 3000ml: ± N2O balance gas: ≤±3%
(expiratory) 20ml or ± 7% of reading value, Backup flow control Pure Oxygen flow rate is 0~10
whichever is greater; Others: L/min: ≤±3%; Others: undefined.
undefined. Auxiliary flow control 10~100% of the full scale: ±10% of
TV 60ml ~ 3000ml: ± 20ml or ± 7% of the reading value. Other ranges:
(Inspiratory) reading value, whichever is greater; undefined.
Others: undefined. Alarm Settings
Paw -20 cmH2O~120 cmH2O: ±2.0 Tidal volume
cmH2O or ± 4% of set value, (expiratory) High: 5~1600 ml
whichever is greater; Others: Low: 0 ~1595 ml
undefined. MV High: 2~100L/min
PEEP 0 cmH2O~70 cmH2O: ±2.0 cmH2O Low: 0 ~98L/min
or ± 4% of set value, whichever is Inspired oxygen High: 20~105%
greater; Others: undefined. Low: 18 ~ 103%
Pmean -20 cmH2O~120 cmH2O: ±2.0 Ppeak High: 2 ~100cmH2O
cmH2O or ± 4% of setting value, Low: 0 ~98cmH2O
whichever is greater. Apnea alarm Two (2) triggering conditions are
Others: undefined. satisfied simultaneously:
Pplat 0 cmH2O~120 cmH2O: ±2.0 cmH2O 1. Airway pressure is continuously
or ± 4% of set value, whichever is lower than (PEEP +3) cmH2O for
greater; Others: undefined. more than 30 seconds.
Freq ±1 bpm or ±5% of set value, 2. Expiratory tidal volume is
whichever is the greater. continuously lower than 10ml for
I: E 2: 1~1: 4: ±10% of reading value. more than 30 seconds.
4: 1~2: 1 and 1: 4~1: 12: ±25% of Increase the set values of tidal
setting value; Others: undefined. volume and respiratory frequency
or set it to Manual/spontaneous
mode.
Alarm Audible and visual alarm; breathing circuit in mechanical
Alarm access Easy access by shortcut mode
Flowmeter Volume of CO2
Type Mechanical flowmeter canister 2000ml
N2O range 0 ~10 L/min Water Trap 7mL, easy to be disassembled
Air range 0 ~10 L/min Feature Heated at 134 degree, removable,
O2 range 0 ~10 L/min easy to dismantle and sterilize
Total flow control Air balance gas: 21~100%
N2O balance gas: Gas Monitoring
25~100% Carbon Dioxide (CO2) Modules
Gas Supply Type Mainstream ETCO2, Sidestream
Pipeline gasses O2 ETCO2
Optional O2, Air; O2, N2O; O2, N2O, Air Method Infrared absorption
Backup Display Numeric and curve displayed in
gas-cylinder gasses O2, N2O, Air screen
Pipeline gas Alarm delay 1~10s (step size: 1s)
connection NIST Sweep 6.25 mm/s,12.5 mm/s
Backup cylinder Anesthetic Agent (AG) Module
connection YOKE-CGA Maximum sound
pressure for low
Pressure range at alarm 79dB
inlet 280~600 kPa Measurement type Side stream
Filter 60-80um Module type Phasin ISA AG module
Features Switch easily to the other gas Accuracy ±10ml/min or ±10%, whichever is
without interrupting the ventilation greater
Auxiliary gas supply O2(optional) Monitored CO2, N2O, AA, MAC, Paramagnetic
parameters O2 and BIS
Breathing Circuit Specification Active AGSS
System Pressure Gauge Feature High flow, low vacuum
Range -20~100 cmH2O Size 535mm×120mm×155mm
Accuracy ± (4% of full scales reading + 4% of Weight 2.2kg
reading) Applies ISO 80601-2-13 and YY 0635-2
Adjustable Pressure Limiting (APL)valve Pressure relief device Atmospheric pressure
Range 1~75 cmH2O compensation port
Tactile knob Connector ISO9170-2 or BS6834 standard
indication at >30 cmH2O connector
Accuracy: ±1.0 cmH2O Flow of suction 50-80L/min
Minimum opening Resistance 0.75KPa ,75L/min
pressure 0.3 cmH2O (dry), 0.5 cmH2O Filter Stainless steel mesh, with pore size
(humid) of 60~100μm
Breathing Circuit Parameters ACGO
Compliance ≤4mL/100Pa Connector Taper coaxial fitting of 22mm
Automatically compensates for (outside) and 15 (inside)
compression loss within the Back pressure
generated at the rear
end of anesthesia
≦2kPa
vaporizer and the front- Power (No isolation transformer)
end of ACGO during External AC power supply
quick oxygen charging Input voltage 100~240 V~/ 100~120V~
Flush O2 Input current 3.5~8.5 A/8.5 A
100% fast oxygen Input frequency 50/60 Hz
Vaporizer Leakage current < 500μA
Brand Drager Vaporizer with Auxiliary output supply
Locking interlocking system (Optional: Output voltage 100~240 V~/ 100~120V~
Two vaporizers) Anesthesia Output frequency 50/60 Hz
Automatic machine able to automatic Shipment (Freight)
recognition recognize halogenated gases Package size 1230*930*1610 mm
Gross Weight 181.5 kg

*Notice: Specifications subject to changes without prior

notice. All rights reserved by COMEN