Flashback Technologies CipherOx CRI M1 Instructions For Use Manual Download Page 1

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PN 4047

Flashback M1 Compensatory Reserve

Monitor (Handheld)

with Flashback’s Patented CRI Technology

Instructions for Use

Version 1.0.2

May 2020

Flashback Technologies, Inc. | 1 Little West 12

Street, Suite 505

New York, NY, 10014 USA | flashbacktechnologies.com

Summary of Contents for CipherOx CRI M1

Page 1: ...shback M1 Compensatory Reserve Monitor Handheld with Flashback s Patented CRI Technology Instructions for Use Version 1 0 2 May 2020 Flashback Technologies Inc 1 Little West 12th Street Suite 505 New...

Page 2: ...o Software Symbols and Parameters 10 Parameters 10 Graphical Interface Symbols 10 Gauge 11 Trend 11 Sensor Status 11 Screen Status 12 Battery Status 12 Adjusting the Screen Brightness 12 Powering off...

Page 3: ...x CRI 19 Estimating CRI from Pulsatile Waveforms 20 Performance of CRI 20 Summary of Clinical Study 21 Background Information Regarding Use of CRI 21 Compensatory Reserve 21 Development of the Compens...

Page 4: ...ients with a finger thickness of 0 3 to 1 in hospital and pre hospital settings CRI trends with changes in intravascular volume relative to the individual patient s response to hypovolemia and should...

Page 5: ...d replace the sensor Do not use if any component of the device is visibly damaged Do not use if the battery door is broken or fails to close tightly as this may allow ingress or ESD damage to the devi...

Page 6: ...ying it to a patient The Model M1 is non sterile Do not sterilize autoclave or immerse the Model M1 in liquid Do not pour or spray any liquids into the device Do not use caustic or abrasive cleaning a...

Page 7: ...patient isolation from electrical shock UL Mark for Canada and the United States with respect to electric shock fire and mechanical hazards only in accordance with IEC 60601 1 AAMI ANSI 60601 1 and C...

Page 8: ...angle up to 60 from the vertical and ingress of solid foreign objects greater than or equal to 2 5 mm in diameter per IEC 60529 Do not expose the device to a magnetic resonance MR environment Conventi...

Page 9: ...he left side of the M1 with the Nonin logo facing up see Figure 2 Figure 2 Attaching the Nonin Sensor Using the Nonin Articulated Clip Sensor 1 Insert a finger preferably the index middle or ring fing...

Page 10: ...ually available within 5 to 20 seconds of sensor placement Figure 4 Power on the M1 Guide to Software Symbols and Parameters Parameters HR Heart Rate SpO2 Functional oxygen saturation of arterial hemo...

Page 11: ...ee Figure 6 If the sensor is not connected or there is no signal the trend will continue to move leaving empty space in the graph in order to indicate time has passed since data has been collected Fig...

Page 12: ...battery Less than 20 minutes of device use may remain The battery status indicator is only valid when an alkaline battery is used Adjusting the Screen Brightness The screen starts up in Normal brightn...

Page 13: ...displayed as _ Cleaning the Reusable Sensor Cautions Clean the sensor before applying it to a new patient Unplug the sensor from the M1 before cleaning Do not sterilize autoclave or immerse the senso...

Page 14: ...household bleach containing less than 10 sodium hypochlorite Do not sterilize autoclave or immerse the M1 in liquid of any kind Do not pour or spray any liquids onto the M1 Do not sterilize with EtO D...

Page 15: ...Page 15 of 24 Nonin OEM III Specifications The M1 utilizes the internal Nonin OEM III module to generate SpO2 measurements...

Page 16: ...5 volt AA battery CRI is not displayed Ensure snug connection between M1 and sensor OR Ensure Sensor Status state bottom left corner of M1 display shows a completely green outline and does not displa...

Page 17: ...Group 1 The M1 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11...

Page 18: ...50 DC 27 450 FM 1 kHz Sine 5 Hz Deviation 28 710 745 780 Pulse 217 Hz 50 DC 9 810 870 930 Pulse 18 Hz 50 DC 28 1720 1845 1970 Pulse 18 Hz 50 DC 28 2450 28 5240 5500 5785 9 M1 Compliance The M1 is not...

Page 19: ...l the patient is already near collapse and at risk for poor tissue perfusion progressive acidosis and sudden unexpected hemodynamic decompensation The Compensatory Reserve Index CRI provides a single...

Page 20: ...case CRI is based on the IR PPG signal from the Nonin OEM III 8000AA Performance of CRI CRI is a new physiological monitoring parameter which trends with intravascular volume and can be used by clinic...

Page 21: ...tudied and observed how these parameters change in the setting of acute blood loss have long assumed that hypotension and other signs and symptoms of hemorrhagic shock mark the beginning of circulator...

Page 22: ...Figure 14 o Before intravascular volume loss 95 of CRI values were above 0 75 and 98 of CRI values were above 0 7 o Before intravascular volume loss the mean CRI value was 0 9 95 confidence 0 89 to 0...

Page 23: ...on CRI estimates 95 confidence Linear mixed model analysis with CRI as the outcome and intravascular volume changes as the predictor support the conclusion that CRI trends with changes in intravascul...

Page 24: ...ms CRI estimates are based on reference data collected in ideal conditions Progressive declines to low CRI values indicate measurements based on subjects in clinical studies exhibiting symptoms of inc...