Flashback Technologies M1 Manual de usuario

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 12th Street, Suite 505

New York, NY, 10014 USA | flashbacktechnologies.com

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Table of Contents 
Overview.......................................................................................................................................................4 
Indications for Use........................................................................................................................................4 
Contraindications..........................................................................................................................................4 
Warnings.......................................................................................................................................................5 
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...............................................................................................................................10 
Guide to 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 the M1...................................................................................................................................12 
Battery Replacement ..................................................................................................................................13 
Software Version.........................................................................................................................................13 
Cleaning the Reusable Sensor.....................................................................................................................13 
Cleaning the M1..........................................................................................................................................14 
Nonin 8000AA Articulated Sensor Specifications .......................................................................................14 
Nonin OEM III Specifications.......................................................................................................................15 
Flashback Technical Support.......................................................................................................................16 
Troubleshooting..........................................................................................................................................16 
Calibration...................................................................................................................................................16 
Electromagnetic Compatibility....................................................................................................................16 
Emissions.................................................................................................................................................17 
Immunity.................................................................................................................................................17 

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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 ......................................................................................21 
Compensatory Reserve.......................................................................................................................21 
Development of the Compensatory Reserve Index (CRI) ...................................................................21 
Clinical Validation of CRI .....................................................................................................................22 
Conclusions .........................................................................................................................................24 
Clinical Use Considerations.........................................................................................................................24 
References ..................................................................................................................................................24 
 
 

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Caution: Federal (USA) law restricts sale by or on order of a physician.

Overview

Flashback Technologies’ M1 Compensatory Reserve Monitor (Handheld) calculates and displays the

percentage of the saturation of peripheral oxygen (SpO2), heart rate (HR) in beats per minute, and

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.

READ AND UNDERSTAND THE ENTIRE INSTRUCTIONS FOR USE BEFORE USING THE M1.

These instructions for use are intended for qualified medical providers.

Indications for Use

The M1 is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial

hemoglobin (SpO2), pulse rate (measured by an SpO2sensor), and the Compensatory Reserve Index (CRI),

which trends changes in intravascular volume relative to the individual patient’s response to hypovolemia.

For patients 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 only be used by qualified medical providers as an adjunct to rather than as a

replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the

supine position under non-motion conditions and without cardiovascular disease. CRI has not been

studied in trauma patients.

Contraindications

•Warning: MR-unsafe!

oDo not expose the device to a magnetic resonance (MR) environment.

oThe device may present a risk of projectile injury due to the presence of

ferromagnetic materials that can be attracted by the MR magnet core.

oThermal injury and burns may occur due to the metal components of the device

that can heat during MR scanning.

oThe device may generate artifacts in the MR image.

oThe device may not function properly due to the strong magnetic and

radiofrequency fields generated by the MR scanner.

oDo not use the M1 in an MR environment or in an explosive atmosphere, or on

infant or neonatal patients.

•The device is not defibrillation proof per IEC 60601-1.

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Warnings

•The M1 is only indicated for use with the Nonin Model 8000AA adult articulated sensor (1-meter

cable).

•Inspect the sensor application site at least every 10 minutes to ensure correct sensor alignment,

skin integrity, and that the sensor temperature does not exceed 42˚C. Patient sensitivity to the

sensor may vary due to medical status or skin condition.

•Avoid excessive pressure to the sensor application site as this may cause damage to the skin

beneath the sensor.

•ADJUNCT WARNING: This device is intended only as an adjunct in patient assessment. It must be

used in conjunction with other methods of assessing clinical signs and symptoms.

•General operationof the Model M1 may be affected by the use of a high-frequency electrosurgical

unit (ESU).

•The use of accessories other than those specified in these instructions may result in increased

electromagnetic emission and/or decreased immunity of this device.

•Keep the device away from young children. Small items such as the battery door, and battery are

choking hazards.

Cautions

•The Model M1 has no audible alarms. Do not use the M1 as an unattended SpO2monitor.

•To prevent degraded SpO2performance and/or patient injury, verify sensor and pulse oximeter

compatibility before use. Only the Nonin Model 8000AA adult articulated sensor with 1-meter

cable should be used with the M1.

•Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately

and 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 device.

•The battery compartment should be inspected periodically for dust and fluid ingress, and any

contaminants removed with a dry cloth.

•The battery compartment door should be closed when operating the device to ensure battery

terminals are not exposed during usage.

•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.

•This equipment complies with IEC 60601-1-2:2014 for electromagnetic compatibility. This

standard is designed to provide reasonable protection against harmful interference in a typical

medical installation. However, because of the proliferation of radio-frequency transmitting

equipment and other sources of electrical noise in healthcare and other environments, it is

possible that high levels of such interference due to close proximity or strength of a source might

disrupt the performance of this device. Medical electrical equipment needs special precautions

regarding EMC, and all equipment must be installed and put into service according to the EMC

information specified in this manual.

•Portable and mobile RF communications equipment may affect medical electrical equipment.

•A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or probe.

•Factors that may degrade M1 device performance or affect the accuracy of the measurements

provided include the following:

Page 6of 24

oDo not apply the sensor on the same arm as a blood pressure cuff, arterial catheter or

infusion line(s) (IVs)

oFinger is outside recommended size range or patient weight range

oCardiogreen and other intravascular dyes

oPoor pulse quality

oArtificial nails or fingernail polish

oExcessive ambient light

oVenous pulsations

oImproperly applied device

oExcessive motion

oCarboxyhemoglobin

oDysfunctional hemoglobin

oMoisture in the sensor or device

oImproperly applied sensor

oMethemoglobin

oHigh-frequency electrosurgical interference

oResidue (e.g., dried blood, dirt, grease, oil) in the light path

oIncorrect sensor type

oCardiovascular dyes

oAnemia or low hemoglobin concentrations

oSensor 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. No readings or poor readings will prevent data updates.

•In some circumstances, the Model M1 may interpret motion as good pulse quality. Minimize

patient motion as much as possible.

•Clean the Model M1 before applying 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 agents, or any cleaning products containing ammonium

chloride or isopropyl alcohol.

•This Model M1 is a precision electronic instrument and must be repaired by qualified technical

professionals. Field repair of the device is not possible. Do not attempt to open the case or repair

the electronics. Opening the case will damage the device and void the warranty.

•Batteries may leak or explode if used or disposed of improperly. Remove the battery from the M1

if the device will be stored for more than 30 days.

•A power supply is not included with this ME Equipment and therefore should not be used as an

ME System.

•Follow local, state, or national governing ordinances and recycling instructions regarding disposal

or recycling of the device and device components.

•Care should be taken to avoid device contact with the patient, other than the Nonin Model

8000AA fingertip sensor.

•The operator should briefly touch the device (less than one second) to ensure that it is not

overheating, before handling the device. If the external temperature of the device is greater than

48˚C, the device should immediately be turned off and the sensor removed from the patient. The

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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. 60601.1.

Serial Number

Battery Orientation

Lot Number

Storage/shipping temperature range (wait 8 hours before using if device has been

in this range)

Storage/shipping humidity range (wait 8 hours before using if device has been in

this range)

Page 8of 24

Symbol

Definition of Symbol

Storage/shipping atmospheric temperature range

Medical prescription required

IP33

Protected from water falling as a spray at any 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

Conventions Used in this Document

Additional information, tips, and hints are listed with a blue, circular, “ i ” icon.

Notices are listed with a yellow, triangular, exclamation point icon.

Page 9of 24

Getting Started with the M1

Insert Battery

Insert a 1.5V AA battery into the battery compartment located on the back of

the unit. The battery compartment can be opened by pulling outward from the

indentation on back of the device. The battery should be replaced with the

negative side (-) pressed upon the battery contact containing a spring (see Figure

1). Close the battery compartment door to secure the battery. A fresh alkaline

battery should power the device for at least 8 hours of continuous use.

Figure 1 - Insert Battery

Use only an IEC LR06 1.5V AA battery. Usage of a similar sized battery containing a

different voltage could damage the device.

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. Insert a finger (preferably the index, middle, or ring finger) into

the Adult Articulated Finger Clip Sensor (Figure 1) until the end

of the finger reaches the finger stop. Keep the fingernail facing

the sensor top (as shown in Figure 1). Ensure that long

fingernails do not interfere with proper finger position.

2. For the best results when using the sensor for data collection,

secure the sensor cable independently from the sensor with

medical tape, preferably around the base of the finger. Make

sure that the tape securing the cable does not restrict the blood

flow (see Figure 3).

Figure 3 - Insert finger into sensor

The thumb is not recommended for use with the Adult Articulated Finger Clip Sensor.

Note: Proper sensor placement is critical for good performance. If the sensor is not

positioned properly, light may bypass the tissue and result in inaccuracies.

Page 10 of 24

Powering Up the M1

On the top of the device, hold down the power button for approximately 1 second and release. The power

button is located on the top right of the device and is labeled with a “power” symbol (see Figure 4).

The readings for SpO2and HR will appear before CRI

and are usually available within 2 to 4 seconds of

sensor placement. The CRI reading is usually

available within 5 to 20 seconds of sensor

placement.

Figure 4 - Power on the M1

Guide to Software Symbols and Parameters

Parameters

Heart Rate

SpO2

Functional oxygen saturation of arterial hemoglobin (%SpO2)

CRI

Compensatory Reserve Index

HR, SpO2, 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.

Graphical Interface Symbols

Figure 5 - M1 graphical user interface and symbols

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