4
16. Failure to follow instructions and warnings may result in serious injury
or death.
Cautions
1. This equipment complies with International Standard EN 60601-1-2:
2014 for electromagnetic compatibility for medical electrical equipment
and/or systems. 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,
homecare and other environments, it is possible that high levels of
interference due to close proximity or strength of a source might
disrupt the device’s performance.
2. Radios and cell phones or similar devices can affect the wireless
connection of the system and must be kept at least 2 meters (6.5 feet)
away from the system.
3. If Aulisa GA1001 Digital Vital Sign Monitoring System fails to respond
as described, discontinue use until the situation is corrected by
qualified personnel.
4. Cardiogreen and other intravascular dyes may affect the accuracy of
SpO
2
measurements.
5. The sensor might not work on cold extremities due to reduced
circulation. Warm or rub the foot to increase circulation or reposition
the sensor.
6. Aulisa GA1001 Digital Vital Sign Monitoring System might misinterpret
motion as good pulse quality. Minimize motion of the monitored site.
7. Excessive ambient light may affect the accuracy of the measurement.
8. Inspect and relocate the sensor application site at least every 10 hours
to ensure correct sensor alignment and skin integrity. Patient sensitivity
to sensors may vary due to medical status or skin condition.
9. Do not place liquids on top of the device.
10. Do not immerse the device or any of the components in any liquids.
11. Do not use caustic or abrasive cleaning agents on the device.
12. Do not gas sterilize or autoclave this pulse oximetry system.
13. Batteries might leak or explode if used or disposed of improperly.
14. Follow local governing ordinances and recycling instructions regarding
disposal or recycling of the device and device components, including
batteries.
15. Do not subject the system to extreme hot or cold temperatures,
humidity, or direct sunlight.
16. Do not fasten the Infant Oximeter Module too tightly around the
patient’s foot. Inaccurate readings and patient discomfort could result.
