3
Precautions for Use
Contraindications
1. Do not use any part of this system in an MRI environment.
2. Explosion Hazard: Do not use this system in an explosive atmosphere
or in the presence of flammable anesthetics or gases.
3. This device is not a replacement for a caregiver.
Warnings
1. This system is intended only as an adjunct in patient assessment. It
must be used in conjunction with other methods of assessing clinical
signs and symptoms.
2. A functional tester
cannot be used to assess the accuracy of a pulse
oximeter probe or a pulse oximeter monitor. Pulse oximeters do not
require calibration.
3. Oximeter readings may be affected by the use of an electrosurgical
unit.
4. As with all medical equipment, carefully route all cables to reduce the
possibility of entanglement, strangulation or injury to the patient.
5. Be careful with small parts that can be removed from the device and
swallowed, such as port covers. They are hazardous to children.
6. Excessive pressure to the sensor application site for prolonged periods
may cause damage to the skin beneath the sensor.
7. Do not use a damaged sensor. If the sensor is damaged in any way,
discontinue use immediately and replace the sensor.
8. Do not use in or around water or any other liquid when AC power
adaptor is used.
9. Only use Aulisa GA1001 Digital Vital Sign Monitoring System with
Charging Adaptors provided by Aulisa.
10. Aulisa GA1001 Digital Vital Sign Monitoring System is designed to
determine functional oxygen saturation, the percentage of arterial
oxygen saturation of functional hemoglobin (SpO
2
). Significant levels of
dysfunctional hemoglobin, such as methemoglobin, might affect the
accuracy of the measurement.
11. Anemia may affect the accuracy of the measurement.
12. Use Aulisa GA1001 Digital Vital Sign Monitoring System only when the
components are installed within the specified distances from the
monitored patient
– approximately 10 meters (32.8 feet) spherical
radius from the Infant Oximeter Module to the Display Unit. Moving
outside this range may cause missing, lost, and/or inaccurate data.
13. Loss of monitoring can result if any objects hinder the pulse
measurement. Ensure that no blood flow restrictors (e.g., blood
pressure cuff) hinder pulse measurements.
14. This product is not a substitution for physician supervision.
15. Always refer to Instructions For Use for full warnings and instructions.
