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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 (SpO
2
), 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 (SpO
2
), pulse rate (measured by an SpO
2
sensor), 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!
o
Do not expose the device to a magnetic resonance (MR) environment.
o
The device may present a risk of projectile injury due to the presence of
ferromagnetic materials that can be attracted by the MR magnet core.
o
Thermal injury and burns may occur due to the metal components of the device
that can heat during MR scanning.
o
The device may generate artifacts in the MR image.
o
The device may not function properly due to the strong magnetic and
radiofrequency fields generated by the MR scanner.
o
Do 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.
