Caution (Ref. 201.7.9.2.9.101 Of En 60601-2-27:2014) - Progetti Rescue Life 9 Instructions For Use Manual

Defibrillator
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3 – ACQUISITION OF BIOMEDICAL PARAMETERS

3.1.6 CAUTION (REF. 201.7.9.2.9.101 OF EN 60601-2-27:2014)

Heart rate affection (ref. a9)
The heart rate may be affected by pacemaker pulses with an ineffective paced QRS pattern.
The heart rate will be affected by arrhythmia. When the defibrillation mode is set in "AED" or "ADV" the VF or
VT with heart rate more than 150 bpm rhythm are recommended as shockable.
Default settings (ref. a10):
- Alarms: all OFF, ECG HR alarm: min 30 bpm – max 250 bpm, SpO2 alarm: min 70%, EtCO2 alarm: max 120
mmHg, TEMP alarm: min 20°C – max 40°C.
- ECG gain: 10 mm/mV, sweep speed: 25 mm/s, filters: "MONITOR" mode, defibrillation mode: "MANUAL",
energy: 150 J, pace rate: 60 bpm, pace current: 50 mA.
Fault finding methods (ref. a12)
- In case of ECG base line fluctuation:
- Verify the disposable ECG electrodes placement;
- Make sure patient is not moving.
- In case of ECG with line noise:
- Verify that the electrodes are not touching metallic parts or grounded parts;
- Set filter as "MONITOR".
- In case of impedance error ("ATTACH PADS" message is shown on the display) verify the positioning of the
STANDARD DEFIBRILLATION ELECTRODES. If DISPOSABLE MULTIFUNCTION ELECTRODES are in use make
sure enough conductive gel is applied on each electrode.
- In case of SpO2 values missing, verify the positioning of the SPO2 sensor.
- In case of EtCO2 values missing verify the sensor positioning and check the tubing for obstructions.
PMK pulses rejected (ref. a13)
- 13.a - Rejects pace pulses alone from ± 2 mV to ± 700 mV and width of 0.1 ms to 2 ms;
- 13.b - Rejects pace pulses with normally paced QRS and T-wave range as per 13.a
PS interruption (ref. a14):
After interruption of SUPPLY MAINS more than 30 seconds the device continues to operate on the batteries
supply without loss of functionality or setup.
9
Rescue Life
– Instruction For Use
3-14
Rev.0.5 – 30/03/2022

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