SpO
2
Safety Information
5-12 EarlyVue VS30 Instructions for Use
• WARNING: MR-unsafe!
- Not for use with MRI applications.
- Do not expose the device to a magnetic resonance (MR) environment.
- The device may present a risk of projectile injury due to the presence of ferromagnetic
materials which can be attracted by the MR magnet core.
- Thermal injury and burns may occur due to the metal components of the device which can
heat during MR scanning.
- The device may generate artifacts in the MR image.
- The device may not function properly due to the strong magnetic and radio frequency fields
generated by the MR scanner.
• If your patient has a very low pulse rate or strong arrhythmia, pulse rate readings derived from
SpO
2
may cause nuisance alarms. Use the pleth wave and perfusion index to assess signal
quality. If necessary, use a different method to measure the patient’s pulse rate.
• The SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms are enabled only when the
monitor is in Interval or Continuous monitoring mode. If the monitor is not in Interval or
Continuous monitoring mode, these SpO
2
technical alarms will not sound.
• High/low alarms and Desat alarms may occur less often when the SpO2 Alarm Delay setting is
on. Check the patient frequently.
Caution
• Circulation constriction, skin irritations or lacerations can occur if the sensor is attached to one
location for too long. Inspect the application site every two to three hours to ensure skin quality
and correct optical alignment. If the skin quality changes, move the sensor to another site.
Change the application site at least every four hours.
• Sensors are not sterile and should not be used in a sterile environment.
• Applying the sensor too tightly results in venous pulsation. This can severely obstruct circulation
and lead to inaccurate measurements.
• Follow the sensor’s Instructions for Use; adhere to all warnings and cautions.
• Check that the light emitter and the photo-detector are directly opposite each other. All light
from the emitter must pass through the patient’s tissue.
• Nail polish or nail fungus on the application site may cause inaccurate results.
• Make sure that the sensor is the appropriate size. The sensor should not fall off, nor should it be
too tight.
• When applying the M1193A or M1193T neonatal sensor, do not over-tighten the strap.
• When using the M1195A infant finger sensor, select a finger or toe with a diameter of between 7
mm and 8 mm (0.27" and 0.31").
• If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight —
because the application site is too large or becomes too large due to edema — the excessive
pressure may cause venous congestion distally, leading to interstitial edema, hypoxaemia and
tissue malnutrition.
• For neonatal patients, place all sensor connectors and adapter cable connectors outside the
incubator. The humidity in the incubator can cause inaccurate measurements.
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