Flashback Technologies M1 Instructions For Use Manual

Compensatory reserve monitor (handheld) with flashback’s patented cri technology

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PN 4047

Version 1.0.2

May 2020

Flashback M1 Compensatory Reserve

Monitor (Handheld)

with Flashback's Patented CRI Technology

Instructions for Use

Flashback Technologies, Inc. | 1 Little West 12

Street, Suite 505

New York, NY, 10014 USA | flashbacktechnologies.com

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Summary of Contents for Flashback Technologies M1

Page 1 © 2020 Flashback Technologies, Inc. PN 4047 Version 1.0.2 May 2020 Flashback M1 Compensatory Reserve Monitor (Handheld) with Flashback’s Patented CRI Technology Instructions for Use Flashback Technologies, Inc. | 1 Little West 12 Street, Suite 505 New York, NY, 10014 USA | flashbacktechnologies.com...
Page 2: Table Of Contents
Cautions ................................ 5 Guide to Symbols ............................7 Conventions Used in this Document ......................8 Getting Started with the M1 ......................... 9 Insert Battery ............................9 Attaching the Nonin Sensor ........................9 Using the Nonin Articulated Clip Sensor ....................9 Powering Up the M1 ..........................
Page 3 M1 Compliance ............................18 Nonin 8000AA Warranty ..........................18 M1 Warranty ............................... 18 M1 Data Sheet ............................19 The Compensatory Reserve Index (CRI) ...................... 19 Estimating CRI from Pulsatile Waveforms ....................20 Performance of CRI ..........................20 Summary of Clinical Study .......................... 21 Background Information Regarding Use of CRI ..................
Page 4: Overview
Flashback Technologies’ Compensatory Reserve Index (CRI™). The model M1 is made up of the M1 device and a Nonin 8000AA Sensor (1-meter cable). The Flashback M1 is intended for use in hospitals and ground ambulances, it is not intended for use in homes.
Page 5: Warnings
• The Model M1 can only be powered by battery when used in patient care. The USB connection is only for use by authorized Flashback technicians. Use by end users will void the warranty.
Page 6 Anemia or low hemoglobin concentrations o Sensor not at heart level • The Model M1 may not work when circulation is reduced. Warm or rub the finger, or re- position the device. • The Model M1 display will display dashes when there is no valid sensor data for an extended period.
Page 7: Guide To Symbols
device should not be used again until the source of the excessive heat is mitigated (battery compartment short or otherwise). Guide to Symbols Symbol Definition of Symbol Follow Instructions for Use Caution! Nonin 8000AA Sensor Type BF Applied Part (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 CAN/CSA-C22.2 No.
Page 8: Conventions Used In This Document
Symbol Definition of Symbol Storage/shipping atmospheric temperature range Medical prescription required Protected from water falling as a spray at any angle up to 60° from the vertical and IP33 ingress of solid foreign objects greater than or equal to 2.5 mm in diameter per IEC 60529.
Page 9: Getting Started With The M1
Attaching the Nonin Sensor Attach the Nonin sensor to the device by inserting the black end of the sensor into the DB9 connection on the 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.
Page 10: Powering Up The M1
, and CRI values are displayed below their labels defined above. No signal information will be available on the M1 until the sensor is connected to the unit and the sensor is applied to a fingertip. Dashes are displayed when no signal is available.
Page 11: Gauge
Gauge The “Gauge” to the right of the screen displays the current CRI reading in a bar chart and increments in 10ths. Trend The “Trend” graph to the left of the screen displays up to 20 minutes of the most recent CRI trend values. The trend value is updated every 5 seconds with the average CRI over the last minute.
Page 12: Screen Status
Each press will cycle the brightness mode. Using the lowest acceptable brightness level will prolong battery life. Powering off the M1 The device can be powered off by pressing and holding the power button for approximately 5 seconds, or until the device shuts down.
Page 13: Battery Replacement
Battery Replacement The M1 uses one 1.5 volt AA battery. The battery compartment can be opened by pulling outward from the indentation on back of the device (see Figure 7). The old battery may be removed by turning the device with the opening facing down and tapping the device lightly on your hand to shake the battery free.
Page 14: Cleaning The M1
Cleaning the M1 If the body of the M1 needs to be cleaned, gently wipe the surfaces with a soft cloth dampened with a mild detergent or a 10% bleach/90% water solution (household bleach [containing less than 10% sodium hypochlorite]).
Page 15: Nonin Oem Iii Specifications
Nonin OEM III Specifications The M1 utilizes the internal Nonin OEM III module to generate SpO measurements. Page 15 of 24...
Page 16: Flashback Technical Support
Electromagnetic Compatibility The M1 is suitable for the electromagnetic environment of typical prehospital or hospital settings. During the immunity testing described below the M1 continued to sense, calculate and display the percentage of the saturation of peripheral oxygen (SpO ) within ±2% of simulator set point, heart rate (HR) in beats per minute within ±...
Page 17: Emissions
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the M1 System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Page 18: M1 Compliance
Compliant). Metal loops are integrated in the case to attach the device to a litter, rail, or other object. Opening the case of the M1 will void its warranty and the device will stop functioning. The user cannot patch or modify the device. The device will maintain its compliancy throughout its service life.
Page 19: M1 Data Sheet
M1 Data Sheet Length Width Height Dimensions 3.5” 2.5” 1” 88mm 64mm 25mm Ounces Grams Weight 113.4g Display Daylight readable TFT-color, 2.4” The Compensatory Reserve Index (CRI) Healthy human organ systems are dynamically coupled and physiologically stable. Compensatory mechanisms (e.g. preload, baroreflexes, respiration, etc.), which serve to maintain physiological stability in the setting of acute blood loss, vary in effectiveness among individuals: Some patients reach Cardiovascular (CV) collapse after relatively little blood loss (<1 liter);...
Page 20: Estimating Cri From Pulsatile Waveforms
Estimating CRI from Pulsatile Waveforms Pulsatile physiological waveforms (BP, PPG, etc.) encode significant information about the state of the cardiopulmonary system. Flashback’s data analytics technology is capable of generating accurate models from noisy high dimensional datasets like the LBNP reference database. This dataset allows us to calculate reference CRI values for each subject from known LBNP (mmHg), and our analytics system uses these and accompanying sensor data to create a mapping from waveforms to CRI estimates (see Figure 10Figure 10).
Page 21: Summary Of Clinical Study
In the same study, CRI was able to capture the varying risk resulting from patients with different tolerances to total volume loss, by accurately calculating lower values at lower absolute loss volumes for patients with lower tolerance (S. Moulton, et al. 2017). Figure 12 - CRI in patients with different tolerances to total volume loss Summary of Clinical Study Background Information Regarding Use of CRI...
Page 22: Clinical Validation Of Cri
To characterize the relationship of CRI to significant blood loss and to support regulatory clearance, Flashback Technologies conducted a prospective validation study that enrolled 42 healthy volunteers (19 to 36) undergoing stepwise removal and replacement of approximately 20% of total blood volume while in the supine position at rest (non-motion).
Page 23 There is no significant effect associated with using CRI estimates from different M1 devices (95% confidence). o Turning an M1 device on and off has no significant effect 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 intravascular volume.
Page 24: Conclusions
19-36 years under supine, non-motion conditions. Clinical Use Considerations Clinical users of the M1 should understand the basic principles regarding the derivation of the CRI value as well as the strengths and limitations of research conducted to date. As noted above, in normal volunteers under laboratory conditions, CRI was found to correlate closely with changes in intravascular blood volume (up to ~ 20% of blood volume loss).

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