| GENERAL REQUIREMENTS | |
|---|---|
| Dimensions & Weight | 335 x 225 x 360 mm, 6.5 Kg with two batteries |
| Electrical | AC 100-240 VAC, 50-60 Hz • Rechargeable batteries: 15 VDC 3.2 Ah Lithium-ion |
| Battery Operation Time | 4.5 hours with one battery; 9 hours with two batteries |
| Battery Charge Time | > 2 hours with one battery; < 4 hours with two batteries |
| Shocks | 200 shocks with one new fully-charged battery at 230 J or 500 shocks with two new fully-charged batteries at 230 J |
| Software | Multilingual prompts and texts |
| Memory | Internal memory for ECG data, events and revision up to 10 hours |
| ENVIRONMENTAL CONDITIONS | |
|---|---|
| Temperature (Operational) | 10 – 40 °C |
| Temperature (Storage) | -20 ~ 50 °C |
| Humidity (Operational) | 30 – 75% |
| Humidity (Storage) | 10 – 95% |
| Applied Parts Type | :for ECG: CF defibrillation proof; for defibrillation and other modules BF defibrillation proof |
| Ingress Protection | IP4X |
| DEFIBRILLATION | |
|---|---|
| Waveform | Biphasic Truncated Exponential (BTE), HiCAP technology (Large storage capacitor) |
| Impedance | Compensated, range 25 – 200 Ohm |
| Charge Time | < 8 seconds for 230 J with fully charged batteries |
| AED MODE | |
|---|---|
| Energy | Preset energy at 200 J |
| Protocol | ERC 2021 CPR Guidelines with voice and text prompts |
| Shockable Rhythms | VF with amplitude > 0.15 mV and VT with rhythm >150 bpm |
| Sensitivity | Shockable rhythm-VF > 95%, Shockable rhythm-VT > 75% |
| Specificity | Normal sinusoidal rhythm > 99%, Asystole and other non-shockable rhythms > 99% |
| MANUAL MODE | |
|---|---|
| Energy Range | 1 – 230 J (from 1-10 J in 1 J steps; from 10 to 230 J in 10 J steps) |
| Â Keys | Multifunction trim knob. Charge and shock buttons directly on the front panel for Hands free defibrillation |
| Electrodes | Adult and pediatric reusable standard electrodes with charge/shock button; Adult and pediatric disposable multifunction electrodes |
| Paddles | Defibrillation mode Shock in sync or not sync with the ECG |
| DISPLAY | |
|---|---|
| Type | High resolution TFT color LCD 8.4’’ (800×600 dots) |
| Content | Working information, ECG waveform and value, HR, SpO2, EtCO2, TEMP, and NIBP values, information on filters, alarms and battery/ies charge status |
| Display Mode | 3-, 7-, 12-lead ECG can be visualized on screen |
| ECG | |
|---|---|
| Bandwidth | 0.05 – 120 Hz (-3 dB) in diagnostic mode • 0.6 – 40 Hz (-3 dB) in monitoring mode |
| CMRR | > 98 dB |
| Input Impedance | 50 Mohm |
| ECG Cable | 3-lead ECG cable (selectable I, II or III) – optional
5-lead ECG cable (I, II, III, aVL, aVF, aVR, V) – standard 10-lead ECG cable (I, II, III, aVL, aVF, aVR, V1…..V6) – optional |
| Gain | 2,5, 5, 10, 20, 40 mm/mV |
| Gain | 2,5, 5, 10, 20, 40 mm/mV |
| Speed | 5, 10, 25, 50 mm/s |
| Filters | 50-60 Hz, EMG filter, baseline |
| HR range | 20 – 300 bpm (~ 2%), digital readout on screen |
| Alarm | Minimum HR 20 bpm and maximum HR 250 bpm, customizable values |
| PRINTER | |
|---|---|
| Type | Integrated 3-channel thermal printer for ECG tracing, event information, and values of parameters, such as HR, SpO2, NIBP, etCO2, and TEMP |
| Printing speed | 5, 10, 25, 50 mm/s |
| Paper width | 58 mm |
| Working mode | Manual, automatic (12’’ pre- and post-shock recording) |
| SPO2 (OPTIONAL) | |
|---|---|
| SpO2 range | 0 – 100% |
| HR range | 30 – 250 bpm |
| Accuracy | 70 – 100% ~ 2% for adults with finger clip sensor |
| Alarm | Adjustable, min 50% |
| NIBP (OPTIONAL) | |
|---|---|
| Technique | Oscillometric |
| Accuracy | Meets ANSI/AAMI SP10-2002, EN IEC 80601-2-30 |
| Patient application | Adult/paediatric/neonatal |
| Systolic range | Adult: 40-260mmHg, paediatric: 40-160 mmHg, neonatal: 40-130 mmHg |
| MAP range | Adult: 26-220 mmHg, paediatric: 26-133 mmHg, neonatal: 26-110 mmHg |
| Diastolic range | Adult: 20-200 mmHg, paediatric: 20-120 mmHg, neonatal: 20-100 mmHg |
| PR range | 30-220 bpm |
| PR accuracy | ±2% or ±3 bpm |
| Operating modes | Manual, Long Term Automatic, Stat, Service |
| Intervals | In Automatic mode: 1, 2, 3, 4, 5, 10, 15, 30, 60, and 90 minutes |
| EXTERNAL PACEMAKER (OPTIONAL) | |
|---|---|
| Type | Rectangular wave |
| Operating mode | Permanent, on demand |
| Impulse rate | 30 – 170 bpm, adjustable in steps of 1 bpm |
| Impulse duration | 20, 30, 40 ms |
| Pulse current | 0 – 200 mA, adjustable in steps of 5 mA |
| EtCO2 (OPTIONAL) | |
|---|---|
| Measurement range | 0 to 150 mmHg, accuracy ±2% |
| Respiratory rate | 0 to 150 br/min, ± 1 br/min |
| Standard | IEC/EN 60601-2-4; IEC/EN 60601-1; IEC/EN 60601-1-2 |
| Marking | EC according to Dir. 93/42/EEC |
