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Background and Identification
The Maquet CS300 IABP is a critical medical device intended for cardiogenic shock caused by any heart problems including heart attack, arrhythmia and myocarditis. It also benefits the patients who have heart surgery.
The Maquet CS300 features IntelliSense software that accelerates the device’s adaptation to heart rate and rhythm changes and automates the operations including pressure sensor and timing. It can be operated in auto mode, semi-auto mode and manual mode.
The Maquet CS300 IABP can be distinguished from other Maquet IABP models, including CS100 and CS100i, by its doppler and storage compartments, which are of different sizes and attached to CS300’s console. For the CS100 and CS100i, the doppler and storage compartments come in the same size on the surface of the cart part.
Size: (on Cart) 43.1” H x 22.3” D x 16.8” W (109 cm H x 56.6 cm D x 42.7 cm W)
Display: Color TFT Liquid Crystal Display (LCD) 8.3”(21cm)W x 6.2”(15.8cm)H
- ECG Trigger: Threshold dynamically adjusted by the system for high sensitivity and selectivity of the R-wave detection; Minimum = 120µV ± 20µV at a normal gain; 40µV at max. gain
- Pressure Trigger: Default trigger threshold is automatically adjusted to 38% of the systolic pulse height; 7 mm minimum
- Pacer A Trigger: R-wave detection (as above) except pacer blanking is extended to 100 ms
- Pacer V/A-V Trigger: V Pacer: fixed at a rate up to 185 bpm (no demand pacing)
- A-V Pacer: fixed at a rate up to 125 bpm (no demand pacing) with A-V intervals between 80-224 ms
- Mains Voltage: 100-120 VAC ± 10% or 220-240 VAC ± 10%
- Mains Frequency: 50/60 Hz ± 3 Hz
- Internal Battery: 24 VDC (nominal), 17.2 Amp-hour, approx. 3 hrs. @ 90 bpm
- Battery Type: Maintenance free; Sealed lead-acid
- Pressure Range: 0 to +300 mmHg
- Op. Temp.: 10°C - 40°C
- Op. Humidity: 5 - 95% (R.H.) non-condensing
- Op. Altitude: 0 - 12,000 feet (3,657 m); automatic altitude correction for IAB pressure
- ECG Leads: In Auto Operation Mode: I, II, III, External In Semi-Auto Mode: I, II, III, AVR, AVL, AVF, V, External (12 lead compatibility)
- ECG Gain (default): 1 V output per 1 mV input ±5% (waveform automatically scaled to occupy ECG display window)
- Gain (variable): 0.15 to 3.0 cm/mV ±20% (autoscaling disabled)
- Frequency Response: 0.5-12 Hz (display); 0.5-135 Hz (Output to External Monitor)
- Defibrillator Protection: Discharge level ≤ 360 J (trace returns to screen in 5 sec max)
- ESIS: Automatic suppression with internal ECG amplifier
FDA’s page regarding Maquet CS300