| 1. Patient types | |
| Adult | |
| Pediatric ( 20kg) | |
| 2. Modes/therapy | |
| Standard | |
| HFT (high flow therapy), standard in V60 Plus* and optional V60 Plus activation key for V60* |
|
| CPAP (continuous positive airway pressure) | |
| S/T (spontaneous with timed backup) | |
| PCV (pressure control ventilation) | |
| AVAPS (average volume assured pressure support) | |
| Optional | |
| PPV (proportional pressure ventilation)** Auto-Trak+** |
|
| 3. Settings | |
| Settings | Range |
| Flow (HFT only) (V60 Plus only) | 10 – 80 l/min† |
| C-Flex | OFF, 1 – 3 |
| CPAP | 4 – 25 cmH 2 O |
| EPAP | 4 – 25 cmH 2 O |
| IPAP | 4 – 40 cmH 2 O |
| I-time (inspiratory time) | 0.30 – 3.00 sec |
| Max P (AVAPS maximum IPAP) | 6 – 40 cmH 2 O |
| Min P (AVAPS minimum IPAP) | 5 – 30 cmH 2 O |
| O2 (oxygen percent) | 21 – 100% |
| Ramp time | OFF, 5 – 45 min |
| Rate (respiratory rate) | 4 – 60 bpm |
| Rise (rise time) | 1 – 5 |
| Triggering and cycling | Auto-adaptive (Auto-Trak) |
| AVAPS target tidal volume | 200 – 2,000 ml btps |
| Max E | 0 – 100 cmH 2 O/I |
| Max R | 0 – 50 cmH 2 O/l/s |
| PPV% | 0 – 100% |
| Max P (maximum PPV pressure limit) | 5 – 40 cmH 2 O |
| Max V (maximum PPV volume limit) | 200 – 3,500 ml |
| 4. Modes/therapy with settings | 6. Alarms ‡ | ||||
| CPAP | S/T | PCV | AVAPS PPV** HFT* | Alarm | Adjustable range |
| Rate | Hi Rate (high respiratory rate alarm) 5 – 90 bpm | ||||
| I-time | Lo Rate (low respiratory rate alarm) 1 – 89 bpm | ||||
| CPAP | Hi V T (high tidal volume alarm) | 200 – 3,500 ml | |||
| EPAP | Lo V T (low tidal volume alarm) | Off, 5 – 1,500 ml | |||
| IPAP | HIP (high inspiratory pressure alarm) 5 – 50 cmH 2 O | ||||
| Rise | LIP (low inspiratory pressure alarm) OFF, 1 – 40 cmH 2 O | ||||
| Min P | Lo V E(low minute ventilation alarm) | OFF, 0.1 – 99 l/min | |||
| Max P | LIP T (low inspiratory pressure | 5 – 60 sec | |||
| Max V | delay time) | ||||
| Max E | ‡ Note: There are no patient parameter alarms available in HFT | ||||
| Max R | |||||
| PPV% | 7. Other settings | ||||
| O2 | Alarm volume | 1 – 10 (relative scale) | |||
| V (tidal volume) | Brightness | 1 – 5 (relative scale) | |||
| C-Flex | Exhalation port selection | • DEP (disposable | |||
| Ramp time | exhalation port) • Whisper Swivel |
||||
| Flow | • PEV (plateau exhalation valve) • Other |
||||
| 5. Monitored parameters ‡ | • None (no circuit exhalation port) |
||||
| Patient data window | Interface selection | ET/Trach, 1, 2, 3, Other | |||
| Breath phase/trigger indicator | Spont, timed, exhale | Screen lock | Off, On | ||
| PIP | 0 – 50 cmH 2O | Auto-Trak Plus** | Optional | ||
| Patient/total leak | 0 – 200 l/min btps | Trigger** | Normal, 1 – 7 | ||
| Patient trigger | 0 – 100% | E-cycle** | -2, -1, Normal, 1 – 6 | ||
| Respiratory rate | 0 – 90 bpm | ||||
| Ti/Ttot | 0 – 91% | 8. Environmental | |||
| Minute volume | 0 – 99.0 l/min btps | Temperature | |||
| Tidal volume | 0 – 3,500 ml btps | Operating conditions | +5 – +40oC | ||
| ‡ Note: There are no monitored parameters available in HFT | Storage conditions | -20 – +50oC | |||
| Waveform window ‡ | Relative humidity | ||||
| Pressure waveform | 0 – 50 cmH 2 O | Operating conditions | 15 – 95% (non-condensing) | ||
| Flow waveform | -240 – 240 l/min btps | Storage conditions | 10 – 95% (non-condensing) | ||
| Volume waveform | 0 – 3,500 ml btps | Barometric pressure | |||
| ‡ Note: Only a flow waveform is available in HFT | Operation | 79.9 – 101.1 kPa(600 – 765 mmHg) | |||
| Altitude | |||||
| Operation | 600 to 765 mmHg | ||||
| * Not available in the USA and may not be available in all markets. | (approximately -61 to 1951 m | ||||
| ** May not be available in all markets. | [-200 to 6400 ft)] | ||||
| relative to sea level) | |||||
| 9. Communication | EN 60601-1 | Medical electrical equipment – Part 1: | ||
| Philips IntelliBridge EC10 | General requirements for safety | |||
| Philips IntelliBridge EC40/80 | EN 60601-1-1 | Medical electrical equipment – Part 1-1: General requirements for safety; |
||
| Philips VueLink Open Interface | collateral standard | |||
| Respi-Link remote diagnostic system | EN 60601-1-4 | Medical electrical equipment – Part 1-4: | ||
| Bernoulli® management system | General requirements for safety;collateral standard | |||
| Capsule DataCaptor device interface driver | EN 60601-1-6 | Medical electrical equipment – Part 1-6: | ||
| GE Healthcare (Centricity TM Critical Care) | General requirements for safety; | |||
| Cerner CareAware® iBusTM | collateral standard | |||
| Other monitoring and patient information systems | EN 60601-1-8 | Medical electrical equipment – Part 1-8:General requirements for safety; | ||
| RS232 digital and analog | collateral standard | |||
| IEC 60601-2-12 | Medical electrical equipment – Part 2-12: Particular requirements for the safety of lung |
|||
| 10. Electrical | ventilators; critical care ventilators | |||
| External | WEEE recycling directive |
Compliant with the WEEE recycling directive | ||
| AC voltage | 100 – 240 VAC | 3rd edition standards | ||
| AC frequency | 50/60 Hz | IEC 60601-1; | Medical electrical equipment – Part 1: | |
| AC power | 300 VA | 2012, Ed. 3.1 | General requirements for basic safety | |
| Battery (optional) | and essential performance | |||
| Nominal voltage | 14.4 V | IEC 60601-1-6; 2013, Ed. 3.1 |
Medical electrical equipment – Part 1-6: General requirements for basic safety |
|
| Capacity | 11.0 Ah | and essential performance; collateral | ||
| Battery chemistry | Lithium-ion | standard: usability | ||
| Operating time | 6 hours in normal | conditions | IEC 60601-1-8; 2012, Ed. 2.1 |
Medical electrical equipment – Part 1-8: General requirements for basic safety and essential requirements; collateral standard: alarm systems |
| 11. Physical | IEC 62366-1; 2015, Ed. 1.1 |
Medical devices – Application of usability engineering to medical devices |
||
| Weight | 11.7 kg (25.7 lb) with optional battery 10.6 kg (23.3 lb) without optional battery |
ISO 14971;2007 | Medical devices – Application of riskmanagement to medical devices | |
| Dimensions | 33.7 cm (13.3 in) height 39.4 cm (15.5 in) width |
EN ISO 14971; 2012 |
Medical devices – Application of risk management to medical devices |
|
| 42.9 cm (16.5 in) depth | ISO 80601-2-12; 2011 |
Medical electrical equipment – Particular requirements for basic safety and essential performance of critical care ventilators |
||
| 12. Regulatory compliance | IEC 60529; | Degrees of protection provided by | ||
| 2nd edition standards | 2013, Ed. 2.2 | enclosures (IP code) | ||
| CSA C22.2 No. 601.1 |
Medical electrical equipment – Part 1: General requirements for safety |
IEC 62304; 2015, Ed. 1.1 |
Medical device software – Software life cycle processes |
|
| EN 60529 | Degrees of ingress protection provided by | WEEE recycling | Compliant with the WEEE recycling directive | |
| enclosures (IPX1@zero degrees tilt) | ||||
| directive | ||||
