6
10.
Do not use this device if it is damaged in any way. Discontinue using it
immediately and replace a new one.
11.
Do not use in or around water or any other liquid when AC power adaptor is
used.
12.
Only use this device with charging adaptors provided by Aulisa.
13.
This device is designed to determine functional oxygen saturation, the
percentage of arterial oxygen saturation of functional hemoglobin. Significant
levels of dysfunctional hemoglobin, such as methemoglobin, might affect the
accuracy of the measurement.
14.
Use this device only when it is within the specified distances, approximately
32.8 feet (10 meters) spherical radius to Guardian Angel® Rx Digital Vital Sign
Monitoring System. Moving outside this range may cause missing, lost, and/or
inaccurate data.
15.
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.
16.
This device is not a substitution for physician supervision.
17.
Always refer to Instructions For Use for full warnings and instructions.
18.
Failure to follow instructions and warnings may result in serious injury or death.
Cautions
1.
This device complies with International Standard IEC 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 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
this device and must be kept at least 6.5 feet (2 meters) away from it.
3.
If this device 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.
This device might not work on cold extremities due to reduced circulation.
Warm or rub the foot to increase circulation or reposition the sensor.
6.
This device might misinterpret motion as good pulse quality. Minimize motion
