Technical Specifications - A9800 Anesthesia Workstation Physical Specifications Ventilator Operating Dimensions Specifications Height Width Depth (without YOKE) Weight (basic unit) 1410mm 920mm 760mm Approximately 130kg Modes of ventilation – standard Standby, Manual, VCV; Demo Top Shelf Weight limit Width Depth Modes of ventilation – Options 25kg/55Ib 650mm 380mm PCV, SIMV-VC, SIMV-PC, PCV-VG, PS(with Apnea backup) Work surface Height Width Depth 850mm 630mm 320mm Ventilator parameter ranges Tidal volume range 20 to 1500mL (volume control modes) 5 to 1500mL (pressure Flip-up side tray Height Weight limit Width Depth control modes) 850mm 12kg 265mm 330mm Incremental settings increments of 5mL(Set Vt below 100mL) or 10mL(when Drawers (internal dimensions) Quantity Height Width Depth between 3 130mm 490mm 350mm 100 Vt and 1000mL) or 50mL(when set Vt bigger than 1000mL) Pressure (Pmax) range Casters Diameter Brakes set 125mm Individual locking front casters 10 - 70 cmH2O (volume control modes) Pressure (ΔP) range 3 to 50 cmH2O (increments of 1 Cylinder(optional) Interface Type Number cmH2O) PISS E Maximum 3 cylinders (SIMV-VC, SIMV-PC, and PS modes) Pressure (PTARGET) 5 to 70 cmH2O range (increments of 1 cmH2O) (PCV and SIMV-PC vent mode) Page 1 of 9 Technical Specifications - A9800 Anesthesia Workstation (increments of 1 cmH2O) Rate 4 to 100 breaths per (VCV, PCV, SIMV-VC, minute for VCV, PCV, SIMV-PC, PCV-VG and PCV-VG; PS vent modes) 2 to 100 breaths per minute for SIMV-VC Ventilator performance and SIMV-PC; Pressure range at inlet 2 to 60 breaths per 280kPa to 600kPa/ 40.6psig to 87psig minute for PS vent mode (increments Peak gas flow of 1 breath per minute) ≥90 L/min + fresh gas flow Inspiratory/expiratory 4:1~1:8 Ventilator monitoring ratio (increments of 0.5) Expiratory minute (VCV, PCV and volume range 0L~30L PCV-VG vent modes) Expiratory tidal volume Inspiratory time 0.2s~5 seconds 0 mL~3000mL range (increments of 0.1 seconds) O2% 18%~100% SIMV-PC vent modes) Peak pressure (Ppeak) -20cmH2O~99cmH2O OFF, 5%~60% Mean pressure (Pmean) -20cmH2O~99cmH2O Plat pressure (Pplat) -20cmH2O~99cmH2O PEEP -20cmH2O~ (SIMV-VC and Inspiratory Pause Time (VCV and SIMV-VC vent modes) Flow trigger 1 L/min~15L/min (SIMV-VC, SIMV-PC 99cmH2O and PS vent modes) Frequency TSLOPE (Inspiratory 0s~2 seconds Slope Time) (increments of 0.1 0~110 breaths per minute seconds) Trend chart (PCV, SIMV-VC, Continuous trend information together with time SIMV-PC and PS vent discrete events are stored and shown in the table, modes) including Ppeak, Pplat, Pmean, PEEP, Freq, VT, MV, FiO2, etCO2, FiCO2, Agent1, Agent2, N2O, Positive End Expiratory Pressure (PEEP) MAC, FG-O2, FG-Air and FG-N2O. The left page Type Integrated, shall include the 10 parameters and the remains electronically controlled shall be in the right page. OFF, 3 to 30 cmH2O Trend table Range Page 2 of 9 Technical Specifications - A9800 Anesthesia Workstation The Setting shall include the patient type, the vent mode and all the setting parameters. The Monitor shall include all Insp. HAL the Low: OFF, 0.1-8.3% High: 0.1-8.4% monitor parameters in the trend data. The machine shall remember the last 8 hours Insp. ISO High: 0.1-8.4% trend data, and the interval shall be 30 seconds. Delivery/monitoring accuracy Volume delivery Low: OFF, 0.1-8.3% Insp. ENF Low: OFF, 0.1-9.8% High: 0.1-9.9% < 100 mL = better than 10 mL > 100 mL = better than Insp. DES High: 0.1-21.9% 10% Pressure delivery ±10% or ±3cmH2O Low: OFF, 0.1-21.8% Insp. SEV Low: OFF, 0.1-9.8% High: 0.1-9.9% PEEP delivery ±2cmH2O or ±10% Apnea alarm Volume monitoring Mechanical ventilation < 100 mL = better than ON: 10 mL Vt< 10 mL breath or > 100 mL = better Pmean<1 cmH2O than10% measured in 30 seconds when Pressure monitoring ±10% or ±3cmH2O Frequency≥6 Vt < 10 mL breath or Alarm settings Minute volume (MVexp) Pmean<1 cmH2O Low: 0 to 20 L/min measured in 35 High:1 to 25 L/min seconds when Frequency<6 Low airway pressure 0~70cmH2O Mechanical ventilation OFF: High pressure 10cmH2O~80cmH2O < 10 mL breath measured in 60 High Breath Rate 8-60bpm seconds Inspired oxygen (FiO2) Low: 18 to 99% Sustained airway Mechanical ventilation High: 21 to 100% pressure ON: Paw>PEEP add 10 exhalant CO2 (etCO2) Low: OFF, 0.1-9.8% or cmH2O measured over OFF, 1-74 mmHg 15 seconds High: 0.1-9.9% or Continuously 1-75mmHg Mechanical ventilation OFF: Inspired CO2 (FiCO2) High: 0.1-1.4% or Paw>10 cmH2O 1-10 mmHg measured over 15 Page 3 of 9 Technical Specifications - A9800 Anesthesia Workstation seconds Continuously Subatmospheric Paw < -2 cmH2O ExpAgent2) Display graphics pressure Waveform of P-T, F-T, V-T, CO2-T, Paw-V Loop, V-Flow Loop Alarm silence 120 to 0 seconds countdown timer Communication ports RS-232 serial port(DB9); Ventilator components RJ45 connector, 100-Base-TX, support HL7 communication Flow transducer Type protocol; fixed orifice USB. (honeycomb) Integrated safety functions Location Installed in breathing In case of electricity and battery failure, manual system ventilation, gas delivery and agent delivery are possible. Oxygen Sensor Positive pressure relief valve opens at about Type Galvanic fuel cell Life Cycle proximately 12 months 85cmH2O. (Dependent on usage) Anesthetic agent delivery Color active matrix TFT Delivery with Touch screen Vaporizer A9040/A9050 15 inch diagonal Type Halothane, Enflurane, Ventilator Screen Display type Display size Isoflurane, Sevoflurane, Pixel format Display parameters 1024×768 Number of positions 2 All settings and alarm Third parking position Optional parameters(including Mounting Selectatec○R manifold VT, Freq., I:E, TINSP, with interlocks PEEP, FreqMIN, TP, Trigger, PTARGET, ΔP, TSLOPE, PEAK, Gas monitor(optional) MEAN,PLAT, FiO2, FiCO2, etCO2, MAC, Type InspAgent1, main stream / side stream ExpAgent1, InspAgent2, Module Page 4 of 9 IRMA CO2; IRMA AX+ Technical Specifications - A9800 Anesthesia Workstation Operating Monitor Gas CO2 Measurement range 0-15 vol% ISA CO2: 0 to 50℃ Accuracy 0-15 vol% ISA AX+: 5 to 50℃ (Standard conditions) ± (0.2 vol% + 2 % of ISA CO2; ISA AX+ IRMA CO2: 0 to 40℃ IRMA AX+: 10 to 40℃ reading) Storage -20 to 70℃ Humidity 10 - 95%(operating, Anesthesia Gas Module Monitor Gases non-condensing), 5 - CO2,N2O,HAL,ISO,ENF SEV;DES 100%(storage, condensing) Measurement range CO2: 0-15 vol% N2O: 0-100 vol% Atm.pres. 525 - 1200 hPa(4572m) HAL, ISO, ENF: 0-8 vol% Calibration Warm-up time No routine calibration is SEV: 0-10 vol% required. DES: 0-22 vol% 20 sec, full Accuracy (Standard conditions) specifications within 60s CO2 0-10 vol% ±(0.2 vol% + 2 % of reading) Rise Time 10-15 vol% ±(0.3 vol% < 350 ms, typically + 2 % of reading) Total system response < 3 sec time N2O ±(2 vol% + 2 % of reading) Breath detect Adaptive threshold, minimum 1vol% change HAL, ISO, ENF in CO2 concentration. Respiratory rate 0 - 150 bpm ± 1 bpm ±(0.15 vol% + 5 % of reading) SEV ±(0.15 vol% + 5 % of reading) Compensation Automatic for atmospheric pressure, DES temperature and ±(0.15 vol% + 5 % of reading) spectral interference Airway adapters (main stream) Adult/Pediatric 6 mL dead space Infant 1 mL dead space Electrical specifications Power and battery backup Power input CO2 Module 100-240V, 50/60Hz, Max. 10A Page 5 of 9 Technical Specifications - A9800 Anesthesia Workstation of N2O with reduction in Battery type Internal re-chargeable, O2 pressure sealed lead acid, Backup power 24VDC, 4AH Supply failure alarm Range: 185 to 215 kPa Demonstrated battery O2 flush Range: 25 to 75 L/min backup time under Charge time typical operating Flowmeter (Electronic) conditions is 120 O2 ranges 0 to 10 L/min; minutes when fully N2O ranges 0 to 10 L/min charged Air ranges 0 to 12 L/min Approximately Integrated safety functions 8hours(in running status O2 and N2O Ratio regulating valve or standby mode) guarantees a minimum O2 concentration of 21% in an O2/N2O mixture. Power cord 5m/16.4ft N2O cut-off if O2 fresh gas valve is closed or if O2 flow is less than 0.2 L/min. Outlets 4 outlets on back, 1.5A Total flow tube Range Pneumatic specifications Auxiliary common gas outlet(optional) Connector ISO 22mm OD and 0-15SLM Air/O2 blender with flowmeter Flow Range 1-15L/min O2 concentration 21%-100% Flow indicator Flow tube 15mm ID Auxiliary gas output(optional) Gas supply Gas type Pipeline input range O2, N2O, Air Gas Oxygen Pressure 280-600kPa Flow rate Max.90L/min 280kPa to 600kPa /41psi to 87psi Breathing circuit Pipeline connections NIST/DISS Cylinder input O2, N2O, Air pin index specifications yokes (PISS) Primary regulator 250kPa/36psig CO2 absorbent canister nominal output Absorbent capacity O2 controls Ports and connectors Method Proportionate decrease Exhalation Page 6 of 9 3000mL 22mm OD ISO 15mm Technical Specifications - A9800 Anesthesia Workstation ID taper Circuit volume 6.9 L Vent Mode (including absorber and Inhalation Bag port 22mm OD ISO 15mm bellows) ID taper 5.4 L Bag Mode 22mm OD Expiratory resistance 0.57 kPa under manual condition Airway pressure gauge Scale range –20 to 100 cmH2O Inspiratory resistance Bag-to-Ventilator switch Type 0.36 kPa under manual condition Manual lever with signal feedback Expiratory resistance 0.47 kPa under automatic Control Controls ventilator and direction of breathing Inspiratory resistance gas within the circuit under automatic 0.35 kPa Integrated Adjustable Pressure Limit (APL) valve Note: According to ISO8835-2, test under peak Range 0 to 70 cmH2O With patient circuit and wye piece added Tactile knob 10 cmH2O and above Heating system(optional) indication at flow 60L/min, fresh gas 10L/min. Temperature 32-40℃ fmainnmainmainMaintaine Adjustment range of 0 to 30 cmH2O (0 to rotation 180°) 30 to 70 cmH2O (180 to 288°) dMaintainedMaintainedMainta Materials ined Controlled to 31 All materials in contact with exhaled patient gases – 35°C are autoclaveable, except mechanical pressure gauge and O2 cell. Accuracy <30 cmH2O:±3 All materials in contact with patient gas are free of cmH2O; natural rubber latex. ≥30 cmH2O:±15% of set value; Anesthetic gas scavenging Breathing circuit parameters Compliance in Bag 3.15 mL /cmH2O mode Mechanical Automatically ventilation mode compensates for System(AGSS) Size 445×142×95 (height x width x depth) compression losses within the absorber and Weight 2.25Kg Type of disposal Low-flow disposal bellows assembly Page 7 of 9 Technical Specifications - A9800 Anesthesia Workstation system system (non-condensing) Extract flow 35L/min~50L/min Barometric Pressure relief device Pressure compensation System storage opening to the Temperature –10 to 60℃ Relative Humidity 15 to 90% 53 to 106kPa atmosphere Filter Stainless screen with ( non-condensing) hole diameter of 150μm Barometric Spillage <100mL/min Electromagnetic compatibility Immunity Max. constant flow 50 to 106kPa 50L/min Complies with all requirements of EN 60601-1-2 Max. intermittent flow 35L/min Emissions CISPR 11 group 1 class B Directive 93/42/EEC Environmental specifications System operation Temperature 10 to 40℃ Relative Humidity 15 to 90% CE mark in this manua product with CE mark. Concerning Medical Devices Concerning Medical Devices Oricare Inc. Address: 1900 AM Drive Quakertown, PA 18951 USA Tel: +1-215-538-2470 Fax: +1-215-538-2578 E-mail: info@oricaremed.com Page 8 of 9 Technical Specifications - A9800 Anesthesia Workstation Page 9 of 9