Indications For Use; Warnings - Nonin LS1 Operator's Manual

Indications for Use

Indications for Use
The LifeSense II, Model LS1, capnography/pulse oximetry monitor is indicated for use in
simultaneously measuring, displaying, monitoring, and recording functional oxygen saturation of
arterial hemoglobin (SpO
poorly perfused adult, pediatric, and infant patients. It is intended for use in environments where
patients require continuous, non-invasive monitoring of these parameters by a healthcare
professional, including hospitals, long-term care, medical facilities, sleep laboratories, home
healthcare, subacute environments, and Emergency Medical Services (EMS), including patient
transport.
Contraindication: Do not use the monitor in an MR environment or in the presence of flammable anesthetics or gases.

Warnings

This system is not intended to be used simultaneously on multiple patients.
This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with other methods of
assessing clinical signs and symptoms.
The monitor is not classified as an apnea monitor.
This monitor is not intended for use with inhalation halogenated agents.
Verify all alarm settings and limits during system start-up to ensure that they are set as intended.
Before each use, it is the operator's responsibility to verify that the alarm limits are appropriate for the patient being monitored.
Ensure that all alarm volumes are audible in all situations. Do not cover or obstruct any speaker openings.
When turning on the monitor, verify that a beep is heard. If a beep is not heard, do not use the device. The speaker may not be
functioning properly.
Atmospheric pressure compensation occurs during system startup.
- An increase in the surrounding environment's atmospheric pressure may cause the system to display incorrect readings until
the system stabilizes.
- A decrease in the surrounding environment's atmospheric pressure may cause the system to not detect an occlusion when
the condition exists.
A hazard can exist if different presets are used on multiple LifeSense II monitors in one care area.
To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor, and accessories before use.
Never allow liquids to enter into or to be spilled onto the monitor. If liquid has penetrated into the monitor, it must be checked by
Nonin Technical Service.
This device is only defibrillation proof when used with Nonin-specified power supplies, cables, and accessories. To avoid
patient injury, only use Nonin-specified power supplies, cables, and accessories (see Accessories).
To avoid patient injury, use only Nonin-branded PureLight
the accuracy specifications of Nonin pulse oximeters. Using other manufacturers' sensors can result in improper pulse
oximeter performance.
Inspect the pulse oximeter sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity.
Patient sensitivity to sensors and/or adhesive strips 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.
Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.
Misuse or improper handling of the pulse oximeter sensor could damage the sensor or the cable, which may lead to inaccurate
readings. Never alter or modify the device or the sensor since this may affect the performance or accuracy.
), end tidal carbon dioxide (EtCO
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pulse oximeter sensors. These sensors are manufactured to meet
), respiration, and pulse rate of well or
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