Edan Elite Series Patient Monitor Product Specifications
A.1 Classification
| Classification | Details |
| Anti-electroshock type | Class I equipment and internal powered equipment |
| EMC type | Group I, Class A |
| Anti-electroshock degree | ECG (RESP), TEMP, IBP, C.O. CF; SpO2, NIBP, CO2, AG BF |
| Ingress Protection | IPX1 |
| Disinfection/sterilization method | Refer to Chapter Care and Cleaning for details. |
| Working system | Continuous operation equipment |
| Compliant with Safety Standards | IEC 60601-1:1988+A1+A2, EN 60601-1:1990+A1+A2, IEC/EN 60601-1-2:2001+A1, ISO_9919, ISO 21647, IEC/EN 60601-2-27, IEC/EN 60601-2-30, IEC/EN 60601-2-34, IEC/EN 60601-2-49, ANSI/AAMI_SP10, IEC/EN 60601-2-25, AAMI/ANSI_EC13, EN12470-4 EN1060-1 EN1060-3, EN1060-4 |
A.2 Physical Specifications
| Product | Dimension | Max Weight | Comments |
| elite V8 | 425 mm (L) × 245 mm (W)× 382 mm (H) | <14 kg | Including batteries, XM module and recorder, without options |
| XM module | 188 mm (L) × 81.5 mm (W)× 120 mm (H) | <1 kg | Without accessories |
| V-IBP module | 134 mm (L) × 38 mm (W)× 102 mm (H) | <0.2 kg | Without accessories |
| V-C.O. module | 134 mm (L) × 38 mm (W)× 102 mm (H) | <0.2 kg | Without accessories |
| V-CO2 module (mainstream) | 134 mm (L) × 38 mm (W)× 102 mm (H) | <0.2 kg | Without accessories |
| V-CO2 module (sidestream) | 134 mm (L) × 84 mm (W)× 102 mm (H) | <0.65 kg | Without accessories |
| V-AG module (mainstream) | 134 mm (L) × 38 mm (W)× 102 mm (H) | <0.2 kg | Without accessories |
| V-AG module (sidestream) | 134 mm (L) × 84 mm (W)× 102 mm (H) | <0.65 kg | Without accessories |
| V-SpO2 module | 134 mm (L) × 38 mm (W)× 102 mm (H) | <0.2 kg | Without accessories |
| PAM | 503 mm (L) × 170 mm (W)× 148 mm (H) | <2.5 kg | Without accessories |
A.3 Environmental Specifications
The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges. When the monitor and related products have differing environmental specifications, the effective range for the combined products is that range which is common to the specifications for all products.
| Main unit, PAM, XM module, V-SpO2 module, V-IBP module, V-C.O. module, Recorder | |
| Temperature | |
| Working | +0°C~+40°C |
| Transport and Storage | -20°C ~ +55°C |
| Humidity | |
| Working | 15% ~ 95% (non-condensing) |
| Transport and Storage | 15%~95% (non-condensing) |
| Altitude | |
| Working | 860hPa ~ 1060hPa |
| Transport and Storage | 700hPa~1060hPa |
| Power Supply | 100V-240V~, 50Hz/60Hz, 1.8A~0.75A. Pmax=180VA FUSE: T3.15AH250VP |
| V-CO2 module (sidestream) | |
| Temperature | |
| Working | +5°C~+35°C |
| Transport and Storage | -20°C ~ +55°C |
| Humidity | |
| Working | 10% ~ 90% (non-condensing) |
| Transport and Storage | 10% ~ 90% (non-condensing) |
| Altitude | |
| Working | 530hPa~1066hPa |
| Transport and Storage | 530hPa~1066hPa |
| V-CO2 module (mainstream) | |
| Temperature | |
| Working | +0°C~+40°C |
| Transport and Storage | -20°C~+55°C |
| Humidity | |
| Working | 10% ~ 90% (non-condensing) |
| Transport and Storage | 10% ~ 90% (non-condensing) |
| Altitude | |
| Working | 530hPa~1066hPa |
| Transport and Storage | 530hPa~1066hPa |
| V-AG module (sidestream) | |
| Temperature | |
| Working | +5°C~+40°C |
| Transport and Storage | -20°C ~ +55°C |
| Humidity | |
| Working | 10% ~ 95% (non-condensing) |
| Transport and Storage | 10% ~ 95% (non-condensing) |
| Altitude | |
| Working | 525hPa ~ 1200hPa |
| Transport and Storage | 500hPa ~ 1200hPa |
| V-AG module (mainstream) | |
| Temperature | |
| Working | +10°C~+40°C |
| Transport and Storage | -20°C ~ +55°C |
| Humidity | |
| Working | 10% ~ 95% (non-condensing) |
| Transport and Storage | 10% ~ 95% (non-condensing) |
| Altitude | |
| Working | 525hPa ~ 1200hPa |
| Transport and Storage | 500hPa ~ 1200hPa |
A.4 Leakage Current
| Applied Part | Normal Condition | Single Fault Condition | |
| Earth Leakage Current | <0.5 mA | <1 mA | |
| Enclosure Leakage Current | <0.1 mA | <0.5 mA | |
| Patient Leakage Current | CF | AC: <0.01 mA DC: <0.01 mA | AC: <0.05 mA DC: <0.05 mA |
| BF | AC: <0.1 mA DC: <0.01 mA | AC: <0.5 mA DC: <0.05 mA | |
| Patient Leakage Current (Mains on Applied Parts) | CF | <0.05 mA | |
| BF | AC: <0.01 mA DC: <0.01 mA | AC: <0.05 mA DC: <0.05 mA | |
| Patient Auxiliary Current | CF | AC: <0.1 mA DC: <0.01 mA | AC: <0.5 mA DC: <0.05 mA |
| BF | AC: <0.1 mA DC: <0.01 mA | AC: <0.5 mA DC: <0.05 mA |
A.5 Display
| Display | Messages |
| Display screen: 17 inch color TFT, touch screen is configurable Resolution: 1280 × 1024 | A maximum of 12 waveforms One power LED One physiological alarm LED One technical alarm LED One alarm mute LED One charge LED |
A.6 Battery
| Attribute | Details |
| Number | 2 |
| Capacity | 4.2 Ah |
| Nominal Voltage | 14.8 V DC |
| Operating Time | 120 min (with 2 new, fully charged batteries, at 25°C, typical configuration (continuous SpO2 measurement and NIBP automatic measurement mode at interval of 15 minutes, ECG/TEMP module connected, recording at interval of 10 minutes, brightness set to "1")) 90 min (with 2 new, fully charged batteries, at 25°C, typical configuration (continuous SpO2 measurement and NIBP automatic measurement mode at interval of 15 minutes, ECG/TEMP module connected, sidestream CO2 and sidestream AG modules connected, recording at interval of 10 minutes, brightness set to "1")) |
| Charge Time | 4.2 Ah 350 min (Monitor is on or in standby mode.) |
A.7 Recorder
| Attribute | Details |
| Record Width | 48 mm |
| Paper Speed | 12.5mm/s, 25 mm/s, 50 mm/s |
| Trace | 1/2/3 optional |
| Recording types | Continuous real-time recording 8 second real-time recording Parameter alarm recording Trend recording Titration table recording Frozen waveform recording |
A.8 Review
| Review Type | Details |
| Trend Review | Short: 1 hr, at 1 second resolution Long: 150 hrs, at 1 min. resolution |
| Review | 1200 sets of NIBP measurement data |
A.9 ECG
| Attribute | Details |
| Lead Mode | 3-Lead: I, II, III 5-Lead: I, II, III, aVR, aVL, aVF, V 12-Lead: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 |
| Lead naming style | AHA, IEC |
| Display Sensitivity | 1.25mm/mV (×0.125), 2.5mm/mV (×0.25), 5mm/mV (×0.5), 10mm/mV (×1), 20mm/mV (×2), 40mm/mV (×4), AUTO gain |
| Sweep | 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s |
| Bandwidth (-3dB) | Diagnosis: 0.05Hz ~ 150Hz Monitor: 0.5Hz ~ 40Hz Surgery: 1Hz ~ 20Hz |
| CMRR (Common Mode Rejection Ratio) | Diagnosis: >95dB (the Notch filter is off) Monitor: >105dB (the Notch filter is on) Surgery: >105dB (the Notch filter is on) |
| Notch | In diagnosis, monitor and surgery modes: 50Hz/60Hz (Notch filter can be turned on or off manually) |
| Differential Impedance | Input: >5ΜΩ |
| Input Signal Range | ±8mV PP |
| Accuracy of Input Signal Reproduction | The total error and frequency response comply with ANSI/AAMI EC13:2002, Sect. 4.2.9.8. |
| Electrode Offset Potential Tolerance | ±500mV |
| Auxiliary Current (Leads off detection) | Active electrode: <100nA Reference electrode: <900nA |
| Input Offset Current | ≤0.1μΑ |
| Recovery time after Defibrillation | <5s |
| Leakage current of patient | <10μΑ |
| Scale signal | 1mVPP, accuracy is ±5% |
| System noise | <30µVPP |
| Sampling frequency | 1000Hz |
| Sampling channel switch time | <80μs |
| A/D precision | 24 Bits |
| ESU Protection | Incision mode: 300W Congelation mode: 100W Restore time: ≤10s Meets the requirements of ANSI/AAMI EC13: 2002 Sect. 4.1.2.1 a) |
| Noise Suppression of Electrotome | Tested according to the test method in EC13: 2002 Sect.5.2.9.14, it complies with ANSI/AAMI EC13:2002 Sect.4.2.9.14. |
| Pace Pulse | Pulse indicator: Pulse is marked if the requirements of ANSI/AAMI EC13:2002, Sect. 4.1.4.1 are met: Amplitude: ±2 mV ~ °700 mV Width: 0.1 ms ~2 ms Ascending time: 10 µs ~ 100 με |
| Pulse Rejection | Pulse is rejected if the requirements of ANSI/AAMI EC13-2002, Sect. 4.1.4.1 are met: Amplitude: ±2 mV ~ °700 mV Width: 0.1 ms ~2 ms Ascending time: 10 µs ~100 με |
| Minimum input slew rate (lead II) | >2.5V/S |
Heart Rate
| Attribute | Details |
| HR Calculation | |
| Range | ADU: 15 bpm ~ 300 bpm PED/NEO: 15 bpm ~ 350 bpm |
| Accuracy | ±1% or 1 bpm, whichever is greater |
| Resolution | 1 bpm |
| Sensibility | ≥300 µVPP |
| PVC | |
| Range | ADU: 0~300 PVCs/ min PED/NEO: 0~350 PVCs/min |
| Resolution | 1 PVCs/min |
| ST value | |
| Range | -2.0 mV ~ +2.0 mV |
| Accuracy | -0.8 mV ~ +0.8 mV: ±0.02 mV or 10%, whichever is greater. Beyond this range: not specified. |
| Resolution | 0.01 mV |
| HR Averaging Method | Method 1: Normally, heart rate is computed by excluding the minimum and maximum values from the 12 most recent RR intervals and averaging the residual 10 RR intervals. Method 2: If each of three consecutive RR intervals is greater than 1200ms, then the four most recent RR intervals are averaged to compute the HR. |
| Range of Sinus and SV Rhythm | Tachy: ADU: 120 bpm ~ 300 bpm, PED/NEO: 160 bpm ~ 350 bpm Normal: ADU: 41 bpm ~ 119 bpm, PED/NEO: 61 bpm ~159 bpm Brady: ADU: 15 bpm ~ 40 bpm, PED/NEO: 15 bpm ~ 60 bpm |
| Range of Ventricular Rhythm | Ventricular Tachycardia: The interval of 5 consecutive ventricular beats is less than 600 ms Ventricular Rhythm: The interval of 5 consecutive ventricular beats ranges from 600 ms to 1000 ms Ventricular Bradycardia: The interval of 5 consecutive ventricular beats is more than 1000 ms |
| Startup time for Tachycardia | Ventricular Tachycardia 1 mV 206bpm: Gain 1.0: 10 s, Gain 0.5: 10 s, Gain 2.0: 10 s Ventricular Tachycardia 2 mV 195bpm: Gain 1.0: 10 s, Gain 0.5: 10 s, Gain 2.0: 10 s |
| Response time of Heart Rate Meter to Change in HR | HR range: 80 bpm ~ 120 bpm Range : 7s ~ 8s, average is 7.5s HR range: 80bpm ~ 40bpm Range : 7s ~8s, average is 7.5s |
| Tall T-wave Rejection | Exceeds ANSI/AAMI EC13-2002 Sect. 4.1.2.1 c) minimum recommended 1.2mV T-Wave amplitude |
| Accuracy of Heart Rate Meter and Response to Irregular Rhythm | Complied with ANSI/AAMI EC13-2002 Sect.4.1.2.1 e), the HR value after 20 seconds of stabilization is displayed as follows: Ventricular bigeminy: 80bpm±1bpm Slow alternating ventricular bigeminy: 60bpm±1bpm Rapid alternating ventricular bigeminy: 120bpm°1bpm Bidirectional systoles: 91bpm±1bpm |
| Arrhythmia analyses | Non-Paced Patient: ASYSTOLE, VFIB/VTAC, COUPLET, VT>2, BIGEMINY, TRIGEMINY, VENT Paced Patient: Ron T, TACHY, BRADY, PNC, PNP, IRR, VBRADY |
12-lead ECG Synchronization Analysis
| Attribute | Details |
| Average parameters of heart beat | Heart rate (bpm) Time limit of P wave (ms) PR interval (ms) QRS interval (ms) QT/QTC (ms) P-QRS-T AXIS |
A.10 RESP
| Attribute | Details |
| Method | Impedance between RA-LL, RA-LA |
| Measurement lead | Options are lead I and II. The default is lead II. |
| Respiration excitation waveform | Sinusoid, 62.8kHz(±10%), <300μΑ |
| Measuring Sensitivity | 200 to 4500 baseline impedance: 0.3Ω |
| Differential input impendence | > 2.5ΜΩ |
| Waveform bandwidth | 0.2Hz ~ 2.5Hz (-3dB) |
| Baseline Impedance Range | 200Ω ~ 2500Ω (no leads cables resistance) 2200Ω ~ 4500Ω (leads cables 1ΚΩ resistance) |
| Noise | <0.1 Ω (3/5-lead monitoring) <0.2 Ω (12-lead monitoring) |
| Maximum dynamic range | Baseline impedance: 500Ω Variable impedance: 3Ω No clipping |
| RR Measuring Range: | Adult: 0 rpm ~120rpm Neo/Ped: 0 rpm ~150rpm |
| Resolution | 1 rpm |
| Accuracy | ±2 rpm |
| Gain Selection | ×0.25, ×0.5, x1, x2, x3, x4, ×5 |
| Apnea Alarm Time Setup | 10s, 15s, 20s, 25s, 30s, 35s, 40s |
A.11 NIBP
| Attribute | Details |
| Technique | Oscillometry |
| Mode | Manual, Auto, Continuous |
| Measuring interval in AUTO Mode | 1/2/3/4/5/10/15/30/60/90/120/240/480 min |
| Continuous | 5min, interval is 5s |
| Measuring type | SYS, DIA, MAP |
| Measuring Range | Adult mode: SYS: 40 mmHg ~ 270 mmHg, DIA: 10 mmHg ~ 215 mmHg, MAP: 20 mmHg ~ 235 mmHg Pediatric mode: SYS: 40 mmHg ~ 200 mmHg, DIA: 10 mmHg ~ 150 mmHg, MAP: 20 mmHg ~ 165 mmHg Neonatal mode: SYS: 40 mmHg ~ 135 mmHg, DIA: 10 mmHg ~ 100 mmHg, MAP: 20 mmHg ~ 110 mmHg |
| Alarm Type | SYS, DIA, МАР |
| Cuff pressure measuring range | 0 mmHg ~ 300 mmHg |
| Pressure resolution | 1mmHg |
| Maximum mean error | ±5mmHg |
| Maximum standard deviation | 8mmHg |
| Maximum measuring period | Adult/Pediatric: 120s Neonate: 90s |
| Typical measuring period | 30s ~ 45s (depend on HR/motion disturbance) |
| Overpressure protection (Dual overpressure protection) | Adult: 297±3mmHg Pediatric: 240±3mmHg Neonatal: 147±3mmHg |
| PR Measuring range | 40 bpm ~240bpm |
| Accuracy | ±3bpm or 3.5%, whichever is greater |
A.12 SpO2
| Attribute | Details |
| Measuring Range | 0 ~ 100 % |
| Alarm Range | 0 ~ 100 % |
| Resolution | 1 % |
| Accuracy | Adult/Pediatric: ±2% (70%~100% SpO2) Undefined (0~69% SpO2) Neonate: ±3% (70%~100% SpO2) Undefined (0~69% SpO2) |
| Pulse Rate | |
| Measuring Range | 25 bpm ~ 300 bpm |
| Alarm Range | 30 bpm ~ 300 bpm |
| Resolution | 1 bpm |
| Accuracy | ±2bpm |
| Data update period | 1s |
| Wave length | Red light: 660±3 nm Infrared light: 905±5 nm |
| Emitted light energy | Less than 15 mW |
| Nellcor module | |
| Measuring Range | 1%~100% |
| Alarm Range | 1%~100% |
| Resolution | 1% |
| Data update period | 1s |
Accuracy
| Sensor Type | Accuracy |
| MAX-A, MAX-AL, MAX-N, MAX-I, MAX-FAST | ± 2 (70% ~ 100% SpO2) |
| OxiCliq A, OxiCliq P, OxiCliq N (Adult), OxiCliq N (Neonate), OxiCliq I | ± 2.5 (70%~100% SpO2) |
| D-YS (Infant to Adult), DS-100A, OXI-A/N, OXI-P/I | ±3(70% ~ 100% SpO2) |
| D-YS (including D-YSE ear clip), D-YS (including D-YSPD spotclip) | ±3.5(70%~100% SpO2) |
| * When the sensor is used on neonates as recommended, the specified accuracy range increases by ±1 compared with that used on adults. | |
| Pulse Rate | |
| Measuring Range | 20bpm ~ 300bpm |
| Resolution | 1bpm |
| Accuracy | ± 3bpm (20bpm ~ 250bpm) |
| Sensor | Wave length: approximately 660 and 900nm Emitted light energy: <15mW |
A.13 TEMP
| Attribute | Details |
| Channel | 2 |
| Sensor type | YSI-10K and YSI-2.252K |
| Technique | Thermal resistance |
| Position | Skin, oral cavity, rectum |
| Measuring Range | 0 °C ~ 50 °C(32 °F ~ 122 °F) |
| Resolution | 0.1°C (0.1 °F) |
| Accuracy (Without sensor) | ±0.1°C or ±0.2 °F |
| Refresh Time | Every 1s ~ 2s |
A.14 IBP
| Attribute | Details |
| Technique | Direct invasive measurement |
| Pressure measuring range | -50 to +300 mmHg |
| Resolution | 1 mmHg |
| Accuracy (without sensor) | ±2% or ±1 mmHg, whichever is greater |
| Pressure sensor | Sensitivity: 5 (µV/V/mmHg) Impedance: 300 to 3000 Ω |
| Frequency response | d.c. to 12.5 or 40 Hz |
| Zero | Range: ±200 mmHg Accuracy: ±1 mmHg |
| Measuring range | Art: 0 mmHg to +300 mmHg PA: -6 to +120mmHg CVP/RAP/LAP/ICP: -10 to +40 mmHg P1/P2: -50 to +300 mmHg |
| Volume displacement of MSI | 4.5 x 10-4 in³ / 100 mmHg |
A.15 CO2
| Attribute | Details |
| Applicable Patient Type | Adult, pediatric and neonatal patients |
| Technique | Infra-red Absorption Technique |
| Unit | mmHg, %, Kpa |
| Measuring Range | EtCO2: 0 mmHg ~ 150 mmHg FiCO2: 3 mmHg ~50 mmHg AwRR: 0 rpm ~ 150 rpm (Mainstream) / 2 rpm ~ 150 rpm (Sidestream) |
| Resolution | EtCO2: 1mmHg FiCO2: 1mmHg AwRR: 1 rpm |
| EtCO2 Accuracy | ± 2 mmHg, 0 to 40 mmHg ±5% of reading, 41 to 70 mmHg ±8% of reading, 71 to 100 mmHg ± 10% of reading, 101 to 150 mmHg |
| AwRR Accuracy | ± 1 rpm |
| Sample Gas Flowrate | 50±10 ml/min |
| O2 Compensation | |
| Range | 0~100% |
| Resolution | 1% |
| Default | 16% |
| Stability | |
| Short Term Drift | Drift over 4 hours < 0.8 mmHg |
| Long Term Drift | 120 hours |
| Initialization time | It displays the value within 15s and meets the requirement for measurement accuracy within 2min. (Mainstream) It displays the value within 20s and meets the requirement for measurement accuracy within 2min. (Sidestream) |
| Response time | 60ms (Mainstream) 3s (Sidestream) |
| Calibration | Not required. |
| Barometric pressure compensation | User setup |
| Alarm Type | EtCO2, FiCO2, AwRR |
| Apnea Alarm Delay | 10s, 15s, 20s, 25s, 30s, 35s, 40s; default value is 20s. |
Interfering Gas and Vapor Effects on EtCO2 Measurement Values
| Gas or vapor | Gas level (%) | Quantitative effect/Comments |
| Dry and Saturated Gas | 0-40 mmHg: ± 1 mmHg additional error 41 – 70 mmHg: ± 2.5% additional error 71 – 100 mmHg: ± 4% additional error 101 - 150 mmHg: ± 5% additional error *Additional worst case error when compensation for PB, O2, N2O, anesthetic agents, or helium is correctly selected for the actual fractional gas constituents present. |
|
| Desflurane: | The presence of desflurane in the exhaled breath at concentrations greater than 5% will positively bias Carbon Dioxide values by up to an additional 3 mmHg at 38mmHg. | |
| Xenon: | The presence of Xenon in the exhaled breath will negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38mmHg. |
Barometric Pressure on EtCO2 Measurement Values:
| Quantitative effect | |
| Ambient Barometric, Operational | 0-40 mmHg: ± 1 mmHg additional error 41-70 mmHg: ± 2.5% additional error 71 – 100 mmHg: ± 4% additional error 101 - 150 mmHg: ± 5% additional error *Additional worst case error when compensation for PB, O2, N2O, anesthetic agents, or helium is correctly selected for the actual fractional gas constituents present. |
A.16 C.O.
| Attribute | Details |
| Technique | Thermodilution Technique |
| Measuring range | C.O.: 0.1 L/min ~ 20L/min TB: 23°C~43°C(73.4 ° F ~109.4 ° F) TI: Auto: -1°C~27°C(30.2 ° F ~80.6°F) Manual: 0°C ~ 27°C(32°F~80.6°F) |
| Resolution | C.O.: 0.1L/min TB, TI: ±0.1°C (+0.1 ° F) |
| Alarm Range | 23°C ~ 43°C (73.4°F~109.4°F) |
| Accuracy | C.O.: ±5% or ± 0.2 L/min TB: ±0.1°C TI: ±0.1°C |
| Output parameters | C.O. Hemodynamic Calculation |
| NOTE: At least 90% of the C.O. data should reside inside the bounded region, and the lower 95% confidence interval should not exceed 85%. | |
A.17 AG
A.17.1 Sidestream
| Module Type | Details |
| ISA AX+ Analyzer | Displaying the concentration of CO2, N2O, and two anaesthesia agent and identifying the anaesthesia agent automatically (portable module) |
| ISA OR+ Analyzer | Displaying the concentration of CO2, O2, N2O, and two anaesthesia agent and identifying the anaesthesia agent automatically (portable module) |
| Measurement Parameters | CO2, N2O, O2, Halothane (HAL), Isoflurane(ISO), Enflurane(ENF), Sevoflurane(SEV), Desflurane(DES), awRR, MAC | |||
| Measurement Principle | CO2, N2O, Anaesthesia Agent: infra-red absorption characteristic; O2: Paramagnetic method | |||
| Sampling Flow Rate | 50 ml/min | |||
| Work Mode | Measurement, Standby | |||
| Warm-up Time | < 20s | |||
| Typical Rise Time | CO2 ≤ 200ms O2 ≤ 350ms N2O ≤ 350ms O2 ≤ 450ms |
|||
| Primary Anaesthesia Agent Threshold | ≤ 0.15 vol% | |||
| Second Anaesthesia Agent Threshold | 0.2 vol% + 10% | |||
| Agent Identification Time | < 20 seconds (typically < 10 seconds) | |||
| Response Time | < 3 seconds | |||
| Standard Conditions | ||||
| GAS | Range | Accuracy | ||
| CO2 | 0 to 15 vol% 15 to 25 vol% |
±(0.2 vol% + 2% of reading) Unspecified |
||
| N2O | 0 to 100 vol% | ±(2 vol% + 2% of reading) | ||
| HAL, ENF, ISO | 0 to 8 vol% 8 to 25 vol% |
±(0.15 vol% + 5% of reading) Unspecified |
||
| SEV | 0 to 10 vol% 10 to 25 vol% |
±(0.15 vol% + 5% of reading) Unspecified |
||
| DES | 0 to 22 vol % 22 to 25 vol% |
±(0.15 vol% + 5% of reading) Unspecified |
||
| O2 | 0 to 100 vol% | ±(1 vol% + 2% of reading) | ||
| All Conditions | ||||
| GAS | Accuracy | |||
| CO2 | ±(0.3 vol% + 4% of reading) | |||
| N2O | ±(2 vol% + 4% of reading) | |||
| Agents | ±(0.2 vol% + 10% of reading) | |||
| Apnea Alarm Delay | 20s~40s | |||
| Alarm | Providing alarms of EtCO2, FiCO2, EtO2, FiO2, EtN2O, FiN2O, EtAA, FiAA, awRR | |||
| Interfering gas and vapor effects: | ||||
| Gas or Vapour | Gas Level | CO2 ISA CO2 | Agents ISA AX+ | N2O |
| N2O⁴) | 60 vol% | _2) | _1) | _1) |
| HAL⁴) | 4 vol% | _1) | _1) | _1) |
| ENF, ISO, SEV⁴) | 5 vol% | +8% of reading ³) | _1) | _1) |
| DES⁴) | 15 vol% | +12% of reading ³) | _1) | _1) |
| Xe(Xenon)⁴) | 80 vol% | -10% of reading ³) | _1) | _1) |
| He(Helium) ⁴) | 50 vol% | -6% of reading ³) | _1) | _1) |
| Metered Dose Inhaler Propellants⁴) | Not for use with metered dose inhaler propellants | |||
| C2H5OH(Ethanol) ⁴) | 0.3 vol% | _1) | _1) | _1) |
| C3H7OH (Isopropanol) ⁴) | 0.5 vol% | _1) | _1) | _1) |
| CH3COCH3 (Acetone) ⁴) | 1 vol% | _1) | _1) | _1) |
| CH4(Methane) ⁴) | 3 vol% | _1) | _1) | _1) |
| CO(Carbon monoxide) ⁵) | 1 vol% | _1) | _1) | _1) |
| NO(Nitrogen monoxide) | 0.02 vol% | _1) | _1) | _1) |
| O2⁵) | 100 vol% | _1&2) | _1&2) | _1) |
| Note 1: Negligible interference, effect included in the specification “Accuracy, all conditions" above. Note 2: Negligible interference with N2O / O2 concentrations correctly set, effect included in the specification "Accuracy, all conditions” above. Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2 readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50 vol% Helium, the actual measured CO2 concentration will typically be (1-0.06)*5.0 vol% =4.7 vol% CO2. Note 4: According to the EN ISO 21647 standard. Note 5: In addition to the EN ISO 21647 standard. |
||||
A.17.2 Mainstream
| Module Type | Details | |||
| IRMA AX+ | Displaying the concentration of CO2, N2O and two anaesthesia agent and indentifying two anaesthesia agent | |||
| Measurement Parameters | CO2, N2O, HAL, Isoflurane(ISO), Enflurane(ENF), Sevoflurane(SEV), Desflurane(DES), awRR, MAC | |||
| Measurement Principle | CO2, N2O, anaesthesia agent: infra-red absorption characteristic | |||
| Warm-up Time | Concentrations are reported and the automatic agent indentification is running within 10 seconds. Full accuracy within 20 seconds | |||
| Rise Time | CO2 ≤ 90ms N2O ≤ 300ms HAL, ISO, ENF, SEV, DES ≤ 300ms |
|||
| Primary Agent Threshold | 0.15 vol% | |||
| Secondary Agent Threshold | 0.2 vol% + 10% of total agent concentration | |||
| Agent Identification Time | < 20 seconds (typically < 10 seconds) | |||
| Response Time | < 1 second | |||
| Standard Conditions | ||||
| Gas | Range | Accuracy | ||
| CO2 | 0~10 vol% 10~15vol% 15~25 vol% |
±(0.2 vol% + 2% of reading) ±(0.3 vol% + 2% of reading) Unspecified |
||
| N2O | 0 to 100 vol% | ±(2 vol% + 2% of reading) | ||
| HAL | 0 to 8 vol% 8 to 25 vol% |
±(0.15 vol% + 5% of reading) Unspecified |
||
| ISO | ||||
| ENF | 0 to 10 vol% 10 to 25 vol% |
±(0.15 vol% + 5% of reading) Unspecified |
||
| SEV | ||||
| DES | 0 to 22 vol% 22 to 25 vol% |
±(0.15 vol% + 5% of reading) Unspecified |
||
| All Conditions | ||||
| GAS | Accuracy | |||
| CO2 | ±(0.3 vol% + 4% of reading) | |||
| N2O | ±(2 vol% + 4% of reading) | |||
| Agents | ±(0.2 vol% + 10% of reading) | |||
| Apnea Alarm Delay | 20s~40s | |||
| Alarm | Providing alarms of EtCO2, FiCO2, EtO2, FiO2, EtN2O, FiN2O, EtAA, FIAA, awRR | |||
| Interfering gas and vapour effects: | ||||
| Gas or vapour | Gas level | CO2 IRMA CO2 | Agents IRMA AX+ | N2O |
| N2O⁴) | 60 vol% | 1&2) | 1&2) | _1) |
| HAL⁴) | 4 vol% | _1) | _1) | _1) |
| ENF, ISO, SEV⁴) | 5 vol% | +8% of reading ³) | _1) | _1) |
| DES⁴) | 15 vol% | +12% of reading ³) | _1) | _1) |
| Xe(Xenon)⁴) | 80 vol% | -10% of reading ³) | _1) | _1) |
| He(Helium) ⁴) | 50 vol% | -6% of reading ³) | _1) | _1) |
| Metered dose inhaler propellants⁴) | Not for use with metered dose inhaler propellants | |||
| C2H5OH(Ethanol) ⁴) | 0.3 vol% | _1) | _1) | _1) |
| C3H7OH (Isopropanol) ⁴) | 0.5 vol% | _1) | _1) | _1) |
| CH3COCH3 (Acetone) ⁴) | 1 vol% | _1) | _1) | _1) |
| CH4(Methane) ⁴) | 3 vol% | _1) | _1) | _1) |
| CO(Carbon monoxide) ⁵) | 1 vol% | _1) | _1) | _1) |
| O2⁵) | 100 vol% | 1&2) | 1&2) | _1) |
A.18 Wireless Network
| Attribute | Details |
| Compliant with Standard and Directive | IEEE802.11b/g, R&TTE Directive (99/5/EEC) |
| Frequency Range | 2.412 GHz~2.462 GHz (America) 2.412 GHz~2.484 GHz (Japan) 2.412 GHz~2.472 GHz (ETSI) |
| Working frequency segment | Ch1 ~ 11 (America) Ch1~14 (Japan) Ch1 ~ 13 (ETSI) |
A.19 Interfaces
A.19.1 Analog Output
| Attribute | Details |
| Bandwidth (-3dB; reference frequency: 10Hz) | Diagnosis: 0.05Hz ~ 100Hz Monitor: 0.5Hz ~ 40Hz Surgery: 1Hz ~ 20Hz |
| Maximum Transmission Delay (Diagnosis Mode) | 500ms |
| Sensitivity | 1V/1mV±10% |
| PACE Rejection/ Enhancement | Not applicable. |
| Waveform Display | Consistent with the calculation leads. |
| Compliant with Standard and Directive | Complies with the requirements in terms of short circuit protection and leakage current in EN60601-1. |
| Output Impedance | <500Ω |
| Interface Type | PJ-365 socket, 3.5mm audio plug |
A.19.2 Defibrillator Synchronization
| Attribute | Details |
| Output Impedance | <500Ω |
| Maximum Time Delay | 35mS (R-wave peak to leading edge of pulse) |
| Waveform | Rectangular wave |
| Amplitude | High level: 3.5V ~ 5V, providing a maximum of 1mA output current; Low level: <0.5V, receiving a maximum of 5mA input current |
| Minimum Required R-wave Amplitude | 0.3mV |
| Pulse Width | 100mS±10% |
| Limited Current | 15mA rating |
| Rising and Falling Time | <1mS |
| Interface Type | BNC-SR-2P connector |
A.19.3 Nurse Call
| Attribute | Details |
| Drive Mode | Voltage Output |
| Power Supply | ≤12VDC, 200mA Max. |
| Contact Type | Normally open or contact (optional) |
| Interface Type | PJ-365 socket, 3.5mm audio plug |
A.19.4 USB Interfaces
| Attribute | Details |
| Number of USB Interfaces | Standard: 4; optional: 4 |
| Drive Mode | HOST interface, USB1.0/2.0 protocol |
| Power Supply | 5VDC, 500mA Max. |
| Interface Type | USB A-type port |
A.19.5 VGA Interface
| Attribute | Details |
| Number of VGA Interface | 1 |
| Horizontal Refreshing Rate | 63.49KHZ |
| Video Signal | 0.7 Vpp 75 Ohm, HSYNC/VSYNC signal TTL |
| Interface Type | DB-15 female receptacle |
A.19.6 DVI Interface
| Attribute | Details |
| *Auto drive is only applicable to DVI display. A HDMI-to-DVI tieline is required. | |
| Clock Rate | 108.0MHZ |
| DVI Video Signal | 1280×1024@85HZ; 4:3; |
| Interface Type | HDMI A-type port |
A.19.7 RS232 Interface
| Attribute | Details |
| Level | RS232 |
| Power Supply | +/-13.2V, 60mA Max. |
| Interface Type | DB-9 female receptacle |
A.19.8 PAM Interface
| Attribute | Details |
| *Only use link cable supplied by EDAN. | |
| Level | RS422 |
| Power Supply | ≤24VDC, 2A Max. |
| Interface Type | POWER USB port |
A.19.9 Network Interface
| Attribute | Details |
| Bandwidth | 10MHZ~100MHZ |
| Interface Type | Standard RJ-45 network interface |
