Warning: The Nox Sleep System is NOT certified to be used for continuous
monitoring where failure to operate can cause injuries or death of the patient.
Warning: External equipment and all auxiliary devices intended for connection to
signal input, signal output or other connectors shall comply with the relevant
product safety standards, e.g. IEC 60950-1 for IT equipment and the IEC 60601
series for medical electrical equipment, to prevent electric shocks. In addition, all
such combinations – systems – shall comply with the safety requirements stated in
the collateral standard IEC 60601-1-1 or the general standard IEC 60601-1, edition
3/3.1, clause 16. Any equipment not complying with the leakage current
requirements in IEC 60601-1 shall be kept outside the patient environment i.e. at
least 1.5 m from the patient support. Any person who connects external
equipment to signal input, signal output or other connectors has formed a system
and is therefore responsible for the system to comply with the requirements. If in
doubt, contact qualified medical technician or your local representative.
Warning: The Nox Sleep System is NOT certified to be used for continuous
monitoring where failure to operate can cause injuries or death of the patient.
Warning: Avoid excessive pressure to the sensor application site as this may cause
damage to the skin beneath the sensor.
Warning: To prevent improper performance and/or patient injury, verify
compatibility of the Nox A1 recorder, oximeter, sensor(s), and accessories before
use.
Warning: Before changing the batteries, make sure the oximeter is off and the
sensor is not applied to a digit.
Caution: The oximeter has motion tolerant software that minimizes the likelihood
of motion artifact being misinterpreted as good pulse quality. In some
circumstances, however, the device may still interpret motion as good pulse
quality.
Caution: To avoid the risk of confusing or misinterpreting patient data when
transmitting data via Bluetooth, verify that the oximeter is paired with the correct
Nox A1 recorder.
Caution: Do not fasten the pulse oximeter too tightly around the patient’s wrist.
Inaccurate readings and patient discomfort could result.
Caution: Do not use a damaged sensor. If the sensor is damaged in any way,
discontinue use immediately and replace the sensor.
Caution: The oximeter is designed to determine the percentage of arterial oxygen
saturation of functional hemoglobin. Factors that may degrade pulse oximeter
performance or affect the accuracy of the measurement include the following:
• excessive ambient light
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