Acutronic Medical Systems
fabian HFO with COVIDIEN etCO2 Microstream MicroPod V1.0 Guide
Guide
5 Pages
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Page 1
VENTILATION BEYOND LIMITS
ACUTRONIC etCO 2
Capnography feature in fabian HFO ®
ACUTRONIC’s fabian HFO is the first neonatal ventilator to integrate COVIDIEN’s Microstream technology to help improve patient saftety on mechanically ventilated newborns. Capnography is the non-invasive method for monitoring exhaled carbon dioxide and it gives an indication of the patient’s efficacy of ventilation. Microstream CO 2 is an innovative, advanced technology for sidestream capnography. It offers fast response time and a low flow rate that does not compete with the neonatal tidal volume, and in addition utilizes a light weight, low dead space airway adapter which does not exert torque on airway tubes. This new feature will allow clinicians to follow real-time waveforms and numeric values for etCO 2 directly on the fabian HFO screen. This will allow clinicians to assess the success of intubation during neonatal resuscitation faster and more reliably. It will also allow one to follow the respiratory trend continuously, which helps to intervene exactly, when it is needed – and non-invasively, which limits Arterial Blood Gas draws. Both, continuous and non-invasive information, further increase the patients comfort and safety. ACUTRONIC is aiming to provide further innovations, such as closed-loop, or near-closed-loop features – in combination with SpO 2 – in the future. ACUTRONIC – Ventilation Beyond Limits. More information: www.acutronic-medical.com or www.covidien.com
Rev. 1.0
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Technical Data Measuring Capabilities Displayed parameters
etCO 2 , FiCO 2 and respiratory rate
Measuring method
Dual-wavelength, non-dispersive infrared spectroscopy
Measuring capabilities
Adult, Pediatric and Neonatal sidestream
etCO 2 measuring range
0 mmHg to 99 mmHg and 0 mmHg to 150 mmHg (at sea level)
Power-up time:
Maximum 10 sec
Initialization time with self-test included:
Typically 30 sec, maximum 180 sec
Calibration
Every 12 months or 4.000 operating hours
Zeroing
Automatic
Sampling flow rate
50 ml/min (+15 ml/min or -7.5 ml/min)
Response time
Max. 4.3 sec (with a standard-length FilterLine)
Reporting resolution
0.1 mmHg
etCO 2 Accuracy (at sea level) 0 to 38 mmHg
± 2 mmHg
39 to 99 mmHg
± (5% of reading + 0.08 x (reading – 39 mmHg))
100 to 150 mmHg
± (5% of reading + 0.08 x (reading –39 mmHg))
Respiratory Rate Measuring range
0 bpm to 150 bpm
Accuracy
0 bpm to 40 bpm +1 bpm 71 bpm to 120 bpm +2 bpm 121 bpm to 150 bpm +3 bpm
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Compensation Atmospheric pressure
Automatic
Alarms
User-adjustable upper and lower alarm limit settings for etCO 2 and respiratory rate Upper alarm limit for FiCO 2
Product specifications Airway adapter dead space
< 0.5 ml (infant/neonatal)
Size (H x W x D)
93,9 mm x 70,0 mm x 50,3 mm
Weight
< 240 gr
Power source
Supplied by the ventilator via the communications cable
Connectors
Sidestream sampling port, Male luer sample exhaust port
Noise emission
Less than 45 dBA (measured at 1 meter)
Water Protection
IPX2 (per IEC 60529)
Environmental Requirements Temperature Range Operating:
0º C to +40º C
Storage:
-40º C to +70º C Relative Humidity Range
Operating:
10% to 95%
Storage:
10% to 95% non-condensing Atmospheric Pressure Range
Operating:
430 mmHg to 795 mmHg (57 kPa to 106 kPa)
Storage:
430 mmHg to 795 mmHg (57 kPa to 106 kPa)
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Standards Standards and Regulations designed to meet: EN 60601-1 UL 60601-1 CSA C22.2 No. 601-1-M90 EN 60601-1-1 Emission Class B Medical Device Directive / CE Mark EN 1789 applicable parts for medical devices EN ISO 14971 (risk mgmt standard) EN 980 (medical symbols) ISO 7137/DO-60 Emission Category M MIL-STD-810F Vibration Method 514.5, Helicopter-category 14 IEC 62304 IEC EN60529 /IPX2 BS EN ISO 21647 (including transport) Meets all applicable standards and regulations required to support a host monitor 510(k) submission.
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Microstream® MicroPod® option Ordering Information Part Number
Description
7227 etCO 2 MicroPod™ Module with Sidestream Microstream technology by Oridion Covidien (Includes 1m pod-comm cable and Sample Kit mixed Neonate) 7380
etCO 2 MicroPod™ Mounting Kit – Universal Includes cradle and clip for mounting on pole or standardized rail.
7376
CapnoLine H Inf/Neo, Nasal sampling for Infant/Neonates Box of 25 pcs.
7377
FilterLine™ H Set Aiway adapter for Infant/Neonates Box of 25 pcs.
Trademarks The following are trademarks of Oridion Medical 1987 Ltd.: Microstream MicroPod™ and FilterLine™. Rev. 1.0
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