Infinity MCable -Masimo SET

Transcription

1 Infinity MCable -Masimo SET Bring the advantages of Masimo s Signal Extraction Technology (SET ) to your pulse oximetry monitoring The noninvasive, motion-tolerant Infinity MCable -Masimo SET works with Infinity M540 patient monitor to provide reliable continuous readings during transport in the hospital and while stationary at the patient s bedside Detects desaturation events during low perfusion and through patient motion Part of the accessory portfolio of Infinity Acute Care System monitoring Helps reduce false alarms D Supports adult, pediatric and neonatal patients

2 02 Infinity MCable -Masimo SET Related Products Infinity M540 D Streamline workflows with a monitor that goes from bedside to transport in the push of a button Leave cables and modules attached to your patient and continue monitoring parameters and alarms in real time, while recording data during travel Use the Infinity M540 as a standalone monitor, or integrate it with hospital IT to access clinical information systems and data analysis applications Infinity Acute Care System Transform your clinical workflow with Infinity Acute Care System Its multiparameter monitor integrates with its networked medical-grade workstation, giving you real-time vital signs, access to clinical hospital systems and data management applications for a comprehensive range of patient information and powerful analysis tools at the point-of-care D D Infinity Gateway Suite Get the most out of your clinical information systems Integrate data from Dräger monitoring and therapy devices with lab results, entries in electronic medical records and clinical information systems across hospital departments Infinity Gateway applications, interfaces and developer tools enable you to exchange information for a more comprehensive view of your patients

3 Infinity MCable -Masimo SET 03 Technical Data Measuring Capabilities Measured parameters Measuring method Saturation (fraction of oxyhemoglobin to functional hemoglobin) and pulse (rate and curve), perfusion index Absorption spectrophotometry Measuring Accuracy Parameter display Measurement range SpO 2 : 1 to 100% Pulse Oximetry (SpO 2 ); Pulse Rate (PLS), Perfusion Index (PI) PLS: bpm PI: % Resolution SpO 2 : 1% Maximum update interval SpO 2 accuracy 1,2 with no motion (adult, pediatric) SpO 2 accuracy 1,2,3 with no motion (neonatal) Accuracy 4 with no motion SpO 2 accuracy 1,2,5 with motion (adult, pediatric) SpO 2 accuracy 1,2,3,5 with motion (neonatal) PLS accuracy 4 with motion Low perfusion accuracy 1,2 (adult, pediatric) PLS: 1 bpm PI: 001% 30 sec 70 to 100% LNCS DCI, LNCS DCIP, LNCS TF-I, LNCS YI (patient weight >3 kg), LNCS Adtx, LNCS Pdtx, LNCS Neo (on finger 6 ) ±2% LNCS TC-I ±35% 70 to 100% LNCS Neo (foot 6 ), LNCS NeoPt, LNCS YI (patient weight 1-3 kg, foot 7 ) ±3% LNCS Inf, LNCS Neo ±2% PLS ±3 bpm 70 to 100% LNCS DCI, LNCS DCIP, LNCS YI, LNCS Adtx, LNCS Pdtx ±3% 70 to 100% LNCS Inf, LNCS Neo, LNCS NeoPt ±3% ±5 bpm LNCS DCI, LNCS DCIP, LNCS TF-I, LNCS Adtx, LNCS Pdtx ±2% LNCS TC-I ±35% Low perfusion accuracy 1,2,3 LNCS (neonatal) Neo (foot 6 ), LNCS NeoPt ±3% Low perfusion PLS accuracy LNCS Inf, LNCS Neo (finger 6 ) ±2% ±3 bpm Perfusion index ±10% Interfering substances: Carboxyhemoglobin may erroneously increase measurement values The level of increase is approximately equal to the amount of carboxyhemoglobin present Dyes, or any substance containing dyes that change arterial pigmentation, may cause erroneous measurement values 1 Since pulse oximeter measurements are statistically distributed, only about two-thirds of those measurements can be expected to fall within ±1 Arms of the value measured by a co-oximeter 2 The Infinity MCable-Masimo SET pulse oximeter with adult sensors has been validated in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of % SpO 2 against a laboratory co-oximeter and ECG monitor This variation equals ±1 Arms of the value measured by a co-oximeter 3 Accuracy of saturation measurements on neonates is decreased by ±1 digit as compared to accuracy on adult patients to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood 4 The pulse rate accuracy has been validated on healthy adult volunteers during induced hypoxia studies in the range of % SpO 2 against a laboratory co-oximeter and ECG monitor This variation equals ±1 Arms of the pulse rate value measured by the ECG monitor 5 Motion defined as continuous rubbing and tapping motions at 2-4 Hz at amplitude of 1-2 cm and continuous random frequency motion between 1-5 Hz at amplitude of 2-3 cm 6 Sensor accuracy depends on the weight of the patient If the weight is less than 3 kg, the accuracy is ±3% For weights above 40 kg, the accuracy is ±2%

4 04 Infinity MCable -Masimo SET Technical Data 7 Sensor accuracy depends on the weight of the neonate If the weight exceeds 3 kg, the accuracy is ±2% For weights between 1 and 3 kg, the accuracy is ±3% (if the sensor is applied on the foot) The Infinity MCable-Masimo SET with LNCS-Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of % SpO 2 against a laboratory co-oximeter and ECG monitor This variation equals plus or minus one standard deviation The Infinity MCable-Masimo SET with LNCS-Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of % SpO 2 against a laboratory co-oximeter and ECG monitor This variation equals plus or minus one standard deviation The Infinity MCable-Masimo SET with LNCS-Neo and Neo Pt sensors has been validated for motion and no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of % SpO 2 against a laboratory co-oximeter and ECG monitor 1% has been added to the results to account for the effects of fetal hemoglobin Nominal wavelength Radiant power at 50 ma pulsed All LNCS sensors except tip clips: Red: 660 nm / IR: 905 nm All LNCS tip clip sensors: Red: 653 nm / IR: 880 nm LNCS TF-I: Red: 660 nm / IR: 880 nm 15 mw User-Selectable Settings Sensitivity Averaging FastSat Mode Normal, APOD, Max 2-4, 4-6, 8, 10, 12, 14, 16 sec On, Off Physical Specifications Size (H x W x D) 20 x 61 x 130 mm (08 x 24 x 51 in) Weight 012 kg (026 lbs) Cable length 300 mm (118 in) Monitor connector 7-pin connector Connectors Intermediate cable for sensor connection Protection against ingress of water IPX2 (per IEC 60529) Defibrillator protection Yes Environmental Requirements Temperature range Operating Storage Relative humidity Operating Storage Atmospheric pressure Operating Storage Electrical Specifications Power source 0 to 45 C (32 to 113 F) -40 to 70 C (-40 to 158 F) 10 to 95% 10 to 95%, with packaging 480 to 795 mmhg (64 to 106 kpa) 375 to 795 mmhg (50 to 106 kpa) Powered directly from the M540 Standards IEC : A1:2012 and applicable particular and collateral standards IEC :2007: Electromagnetic Compatibility ISO :2011 Pulse Oximeter Equipment The Infinity MCable-Masimo SET complies with the Medical Device Directive (MDD) 93/42/EEC and bears the CE mark

5 Infinity MCable -Masimo SET 05 Technical Data Masimo, Masimo SET and Signal Extraction Technology are registered trademarks of Masimo Corporation The Dräger name and logo, Infinity and MCable are registered trademarks of Dräger

6 06 Infinity MCable -Masimo SET Notes Not all products, features, or services are for sale in all countries Mentioned Trademarks are only registered in certain countries and not necessarily in the country in which this material is released Go to wwwdraegercom/trademarks to find the current status en-master HQ PP Subject to modifications 2017 Drägerwerk AG & Co KGaA CORPORATE HEADQUARTERS Drägerwerk AG & Co KGaA Moislinger Allee Lübeck, Germany wwwdraegercom Manufacturer: Draeger Medical Systems, Inc 3135 Quarry Road Telford, PA , USA Locate your Regional Sales Representative at: wwwdraegercom/contact REGION DACH Drägerwerk AG & Co KGaA Moislinger Allee Lübeck, Germany Tel Fax info@draegercom REGION EUROPE Drägerwerk AG & Co KGaA Moislinger Allee Lübeck, Germany Tel Fax info@draegercom REGION MIDDLE EAST, AFRICA Drägerwerk AG & Co KGaA Branch Office PO Box Dubai, United Arab Emirates Tel Fax contactuae@draegercom REGION ASIA PACIFIC Draeger Singapore Pte Ltd 25 International Business Park #04-20/21 German Centre Singapore Tel Fax asiapacific@draegercom REGION NORTH AMERICA Draeger, Inc 3135 Quarry Road Telford, PA , USA Tel DRAGER ( ) Fax infousa@draegercom REGION CENTRAL AND SOUTH AMERICA Dräger Panama S de RL Complejo Business Park, V tower, 10th floor Panama City Tel Fax contactcsa@draegercom