Indications For Use; Warnings - Nonin LifeSense LS1-9R Operator's Manual

Indications for Use

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The LifeSense Model LS1-9R Capnography/Pulse Oximeter monitor is indicated for use in
simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin
(SpO ), end tidal carbon dioxide (EtCO
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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 (e.g.,
hospitals, medical facilities, post-operative care, within facility patient transport or home use.

Warnings

Do not use LifeSense in an MR environment or in the presence of flammable anesthetics or gases.
Do not use LifeSense during defibrillation.
LifeSense is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of
assessing clinical signs and symptoms.
LifeSense is not intended to be used as a primary diagnostic apnea monitor.
Verify all alarm settings and limits during system start up to ensure that they are set as intended.
A hazard can exist if different presets are used on multiple LifeSense monitors in one care area.
To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and accessories
before use.
No modifications to the device are allowed as it may affect device performance.
Inspect the pulse oximeter sensor application site at least every 6 to 8 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.
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.
Accessories marked "single-use" must be used on one patient only and be disposed of after usage.
To avoid patient injury, use only Nonin-branded PureLight
to meet the accuracy specifications of Nonin pulse oximeters. Using other manufacturers' sensors can result in
improper pulse oximeter performance.
Only use power supplies that either are supplied with LifeSense or specified by Nonin (see "Accessories").
When selecting a sensor application site use an extremity without a catheter, blood pressure cuff, or intravascular
infusion line.
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 sensor since this may affect the performance or accuracy.
If the LifeSense fails to respond as described, discontinue use and contact Nonin Technical Service.
Use only Nonin recommended accessories and replacement parts (see "Accessories").
), respiration, and pulse rate of well or poorly perfused
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pulse oximeter sensors. These sensors are manufactured
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