استفاده جهت بزرگسالان و اطفال (حداقل حجم جاری 20 میلی لیتر)
مجهز به صفحه نمايش لمسي رنگي 12اينچ
سهولت کار با دستگاه به دلیل مشخصات فیزیکی مناسب
استفاده بصورت تهاجمی و غیرتهاجمی
تنظیم اتوماتیک پارامترهای تنفسی با تعیین IBW
دارای مدهای متداول و پیشرفته فشاري، حجمي و حجمی – فشاری
قابلیت نمایش منحنی ها و لوپ هاي تنفسی و مقادیر عددی
حفظ و نگهداری اطلاعات به مدت 72 ساعت
داراي آلارم هاي قابل تنظيم و هوشمند
قابلیت کارکرد با باتری داخلی تا 2 ساعت
جبران سازی خودکار نشتی هوا
جبران سازي خودکار Compliance مسیرهای هوایی
داراي تريگر فشاري و فلويي
| Rev | Revision Date | Description of Revision | Prepared by | Review | Review |
| 4 | Initial Release | ||||
| 5 | Adding some monitoring parameters, performing procedures and configuration setting | N. Rahmati | A.Mehrnam | H. AzizZadeh | |
| 6 | 95/12/22 | Adding VBS compliance and resistance, Correcting some parameters value and list of related standards | N. Rahmati | A.Mehrnam | H. AzizZadeh |
| 7 | 96/01/28 | Adding display size, device dimensions and battery specification | N. Rahmati | A.Mehrnam | H. AzizZadeh |
| 8 | 96/06/07 | Correcting setting range of “Peak Flow” | N.Rahmati | A.H. Mehrnam | H. AzizZadeh |
| 9 | 97/07/23 | Changing Ve to MV, editing the range of Air and Oxygen inlet pressure and adding air inlet pressure | N. Rahmati | A.H. Mehrnam | H. AzizZadeh |
| 10 | 97/08/22 | Editing battery information | N. Rahmati | A.H. Mehrnam | H. AzizZadeh |
| 11 | 97/10/17 | Adding transport humidity and temperature | N. Rahmati | A.H. Mehrnam | H. AzizZadeh |
| 12 | 98/01/24 | Adding apnea rate, changing the title of “SPAP” mode into “Bi- level”, adding Bi- level mode settings and changing operating temperature | N. Rahmati | A.H. Mehrnam | H. AzizZadeh |
| 13 | 98/10/10 | Deleting “sigh” and adding trend resolution | N. Rahmati | A.H. Mehrnam | H. AzizZadeh |
| 14 | 98/12/03 | Editing some details in monitoring parameters. | Z.Khalili | A.H. Mehrnam | H. AzizZadeh |
| 15 | 98/12/27 | Editing some details in NIV,
Deleting “Base Flow” from Additional Setting; Renaming P-CMV &V-CMV modes. |
Z.Khalili | A.H. Mehrnam | H. AzizZadeh |
| 16 | 99/05/04 | Editing the range of setting and monitoring “peak flow” and editing some details in NIV | N. Rahamti | A.H. Mehrnam | H. AzizZadeh |
| 17 | 99/09/05 | Editing some details and adding Dual Control option, APRV mode | Z.Khalili | A.H. Mehrnam | H. AzizZadeh |
| 18 | 1400/04/13 | Modify the duration of inhalation and the maximum number of breath in each minute. | Z.Khalili | A.H. Mehrnam | H. AzizZadeh |
Project of ventilator design and manufacture RESPINA P1
Technical specification
The details of technical specification for RESPINA P1 project is defined in this document.
Reference documentations
- D49-A00 Project definition
- Folder containing user manual and service manual of high quality ventilators
- I49-A03 Applicable standards list
| Technical Specification | ||
| Ventilation Modes | Assisted Control Mandatory Ventilation | A/C |
| Synchronized Intermittent Mandatory Ventilation | SIMV | |
| Spontaneous Ventilation | SPONT | |
| Breath Types | Volume–controlled breaths | VCV, V–SIMV
(with Dual Control in the breath) |
| Pressure–controlled breaths | PCV, P–SIMV, PS | |
| Volume Targeted Pressure–controlled breaths (Pressure Regulated Volume Control) & (Volume Support) | PRVC–CMV, PRVC–SIMV, VS | |
| Dual Level PEEP breaths | APRV (with Auto Tlow) | |
| Patient Type | Patient Height | 42 – 250 cm |
| IBW (Ideal Body Weight ) | 5 – 200 Kg | |
| Gender | Male, Female | |
| VBS (Ventilator Breathing System) | Acceptable Compliance range | 0.5 – 5 ml/cmH2O |
| Acceptable Inspiratory Resistance range | 0 – 2.5 cmH2O.s/l | |
| Acceptable Expiratory Resistance range | 0 – 2.5 cmH2O.s/l | |
| Apnea Backup | Settings | On (Rate, Pcontrol,Ti); OFF |
| Breath triggering | Pressure triggering | (-2) – (-20) cmH2O |
| Flow triggering | 2 – 20 l/min | |
| Additional Setting | Respiratory Rate
Accuracy:±1 b/min or 4% wig |
2 – 150 b/min |
| Respiratory Rate in apnea mode
Accuracy:±1 b/min or 4% wig |
5 – 150 b/min | |
| Tidal Volume | 20 – 2000 ml
(Compliance & BTPS compensated) |
|
| PEEP / CPAP
Accuracy:±12% or ±(2cmH2O +4% Actual reading) wig |
0 – 40 cmH2O | |
| Pcontrol
Accuracy: ±12% or ±(2cmH2O +4% Actual reading) wig |
2 – 80 cmH2O | |
| Psupport
Accuracy: ±12% or ±(2cmH2O +4% Actual reading) wig |
0 –60 cmH2O | |
| Peak Flow
Accuracy: ±12% or ±(3 l/min +4% Actual reading) wig |
Mandatory
3– 120 l/min Spontaneous 1 –250/min |
|
| Leak Comp | On or Off | |
| Flow Patterns | Square, Dec | |
| NIV | On or Off
Available in PS, P-SIMV and APRV modes |
|
| I–Time (Ti)
Accuracy: ± 0.02 sec |
0.1 – 10.0 sec | |
| Pause (insp plateau)
Accuracy: ±0.02 sec |
0 – 75 % of Inspiratory time | |
| Rise time | Fast, Med, Slow | |
| Exhalation sensitivity
Accuracy: ±12% or ±(3 l/min +4% Actual reading) wig |
10–80 % of peak flow | |
| Oxygen (FiO2)
Accuracy (Delivery): ± (3 %) full scale |
21 – 100 % | |
| Nebulizer
Accuracy: ±10 s |
On or Off;
User selected duration (1–480 minutes) |
|
| Humidification Type | None, HME, Humidifier | |
| Compliance Compensation | On or Off | |
| Graph Settings | Waveforms: pressure, flow, volume
Loops: P/V , F/V |
|
| Trend Data | All parameters, 72 hours | |
| Trend Resolution | 6 seconds | |
| Selectable displaying measurements | 6 parameters | |
| Audio Settings | Audio Level | |
| APRV Mode Settings | Phigh
Accuracy:±12% or ±(2cmH2O +4% Actual reading) wig |
5 to 40 cmH2O |
| Plow
Accuracy: ±12% or ±(2cmH2O +4% Actual reading) wig |
0 to 37 cmH2O | |
| Thigh
Accuracy: ±0.02 sec |
1.0 to 29.8 sec | |
| Tlow
Accuracy: ±0.02 sec |
0.2 to 2.0 sec | |
| Monitored / Displayed Patient Values | Pressure Values | |
| Ppeak (peak pressure during a breath)
Accuracy: ±12% or ±(2cmH2O +4% Actual reading) wig |
0 – 120 cmH2O | |
| PEEP (pressure at end exhalation)
Accuracy: ±12% or ±(2cmH2O +4% Actual reading) wig |
0 – 120 cmH2O | |
| Pmean (averaged mean pressure)
Accuracy: ±12% or ±(2cmH2O +4% Actual reading) wig |
0 – 120 cmH2O | |
| PendInsp
Accuracy: ±12% or ±(2cmH2O +4% Actual reading) wig |
0 – 120 cmH2O | |
| Volume / Flow Values | ||
| Vte (expiratory tidal volume)
Accuracy: For 50–2000 ml: ± (4 ml + 15% Actual reading) For 20–49 ml: ± (7 ml + 15% Actual reading) |
0 – 3000 ml | |
| Vti
Accuracy: For 50–2000 ml: ± (4 ml + 15% Actual reading) For 20–49 ml: ± (7 ml + 15% Actual reading) |
0 – 3000 ml | |
| MV (exhaled minute volume)
Accuracy: : ±15 % of Actual reading or ±(0.3L/min) wig |
0 – 99 l/min | |
| MVSpont (spontaneous exhaled minute volume) Accuracy: : ±15 % of Actual reading or ±(0.3L/min) wig | 0 – 99 l/min | |
| Leak
Accuracy: ±12 % or ±(3% + 4% Actual reading) wig |
0 – 100% | |
| PF (peak inspiratory flow)
Accuracy: ±12% or ±(3 l/min +4% Actual reading) wig |
0 – 250 l/min | |
| PFe (peak expiratory flow)
Accuracy: ±12% or ±(3 l/min +4% Actual reading) wig |
0 – 250 l/min | |
| Time Values | ||
| Rate (measured mandatory and spontaneous breaths per minute)
Accuracy: ±1 b/min or 4% wig |
0 – 150 b/min | |
| Rate Sp.
Accuracy: ±1 b/min or 4% wig |
0 – 150 b/min | |
| Inspiration Time (Ti)
Accuracy: ± 0.2 sec |
0.1 – 99.9 sec | |
| Expiratory Time (Te)
Accuracy: ± 0.2 sec |
0.1 – 99.9 sec | |
| I:E, calculated only | 1:99 – 99:1 | |
| H:L | 1:599 – 299:1 | |
| Ti/Ttot
Accuracy: ±5% or ±1 wig |
1 – 99.9% | |
| Respiratory Mechanics | ||
| Cstat
(static compliance, lung stiffness) Accuracy: ±10% or ±4 ml/cmH2O wig |
0 – 250 ml/cmH2O | |
| Cdyn
(Dynamic compliance) |
0 – 250 ml/cmH2O | |
| Rinsp
(resistance of airways and tubes) |
0 – 1000 cmH2O/l/sec | |
| Rexp
(Expiratory resistance) |
0 – 1000 cmH2O/l/sec | |
| Auto PEEP (Actual PEEP – set PEEP)
Accuracy: ±12% or ±(2cmH2O +4% Actual reading) wig |
0 – 120 cmH2O | |
| Pplateau
Accuracy: ±12% or ±(2cmH2O +4% Actual reading) wig |
0 – 120 cmH2O | |
| RSBI
(Measured breathing rate divided by Insp tidal volume) (RR/Vt = RSBI) Accuracy: ±10% or ±40 b/min/l wig |
0 – 3000 b/min/l | |
| O2
Accuracy (Delivery): ±3 % Response time < 30 s |
15 – 103% | |
| P0.1
(The maximal slope of the airway pressure drop during the first 100 ms when the airway is occluded.) Accuracy: ± (2 cmH20 + 4%) |
-30 – 0 cmH2O | |
| NIF
(The maximum negative pressure generated during inspiration against an occluded airway) Accuracy: ± (2 cmH20 + 4%) |
-60 – 0 cmH2O | |
| P0.1/NIF | 0 – 100 % | |
| WOBimp
(Work of breathing) Accuracy: ± 10% Actual reading |
0 – 20 j/l | |
| RCe
(Expiratory time constant) |
0 – 99.9 Sec | |
| C20/C
(Compliance ratio) |
0.00 – 5.00 | |
| Real Time Curves | ||
| Pressure-Time , Flow-Time , Volume-Time | Pressure over time, Flow over time, Volume over time | |
| P–V Loop, F–V Loop | Pressure–volume loop, Flow–volume loop | |
| Performing Procedures | Inspiration-Hold | Pause the ventilator at end inspiration
Maximum allowable duration shall be 20 sec |
| Expiration-Hold | Pause the ventilator in expiration
Maximum allowable duration shall be 20 sec |
|
| Manual Breathing | Delivery a mandatory breath during the next expiratory breath in all mode | |
| P0.1 | The maximal slope of the airway pressure drop during the first 100ms while airway is occluded | |
| NIF | The maximum negative pressure generated during inspiration against an occluded airway | |
| Suction | This function allows breaths to be delivered with a 100% O2 concentration, before and after a tracheal suction maneuver.
20 – 120 s; Resolution: 10 |
|
| O2 100% | Delivers O2 100% for 2 minutes | |
| Standby | Places ventilator in standby mode | |
| Nebulizer | During the nebulization time, the nebulizer valve opens synchronous to inspiration to provide pressure for an external medication nebulizer | |
| Advanced features | Dual Control in the breath | Switching from Volume to Pressure control (and vice versa) during the inspiratory phase of each breath cycle (In square flow pattern).
Available in VCV and V-SIMV modes. |
| Auto Tlow | Automatically determination of Tlow to terminate expiration at an adjustable percentage of peak expiratory flow.
Available in APRV mode. |
|
| Active Exhalation Valve
(pressure relief in the inhalation phase) |
Available in all modes | |
| Configuration setting | Nebulizer | On or off, Duration: 1- 480 min, Resolution: 1
Accuracy: ±10 s |
| Humidification Type | None, HME, Humidifier | |
| Compliance Comp | On or Off | |
| Power and Gas Supply | AC input | 100 to 240 VAC (47 – 63 Hz) |
| Battery Backup (full charged battery) | Up to 1 hour and upgradable to 2 hours | |
| High pressure air inlet supply | clean oil-free and medical grade
2.4 – 6.0 bar, full performance 1.0 – 2.4 bar, degraded performance 0.0 – 0.8 bar, alarm situation |
|
| High pressure oxygen inlet supply | clean dry and oil–free medical grade oxygen
2.4 – 6.0 bar, full performance 1.0 – 2.4 bar, degraded performance 0.0 – 0.8 bar, alarm situation |
|
| Battery specification | Type | Two separate Li-Ion batteries |
| Voltage, Energy | 11.1 V, totally > 48 Wh | |
| Alarm System | Auditory alarm | Internal speakers |
| Visual alarm | In the TFT display | |
| Indicator | LED | |
| Types | Technical, Physiological, Messages | |
| Priorities | High, Medium, Low | |
| Environmental Data | Operating temperature | Battery operation: 5 – 40 °C
Mains operation, battery full charged: 5 – 35 °C Mains operation, battery charging: 5 – 30 °C |
| Storage and transport temperature | (-10) – 60 °C | |
| Operating Humidity | 15% – 95% non-condensing | |
| Storage and transport Humidity | 5% – 95% non-condensing | |
| Operating altitude | 11,000 ft (3,500 m) above sea level | |
| Physical Data | Width x depth x height (main case) | 45 x 35 x 29 cm |
| Weight | ≈ 12 Kg | |
| Noise Level | TBD | |
| Display | TFT Size | 12.1” wide, with Touch screen |
| Pressure Safety | Maximum limited pressure | 110 ±10 cmH2O |
| Maximum operating pressure | 80 cmH2O | |
| Compliance and Approvals | Classifications | Class I, Type BF, internally powered, drip–proof equipment for continuous operation
EMC related group and classification: I-B |
| Meets International Standards | EN 60601-1: 2006
EN 60601-1-2: 2015 EN 60601-1-8: 2007/ AC: 2010 ISO 80601-2-12: 2011 |
|