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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 operation of 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 SpO
2
monitor.
• To prevent degraded SpO
2
performance 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:
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