80-0078-00-MO-RevD 2018-08-02 SunTech CT50 User Manual | 6
1. General Introduction
1.1 Intended Use
The CT50 vital signs monitor is intended to be used for monitoring, displaying, reviewing, storing and sending alarms
regarding multiple physiological patient parameters, including pulse oxygen saturation (SpO
2
), pulse rate (PR), non-
invasive blood pressure (NIBP), and temperature (Temp).
The CT50 vital signs monitor is intended to be used in outpatient departments, emergency treatment rooms, low-
acuity areas of hospitals, community clinics, private clinics, and other medical institutions. It is not intended for
helicopter transport, hospital ambulance or home use.
Warning: The monitor is intended for use only by clinical professionals or under their guidance. It must only
be used by persons who have received adequate training in its use. Anyone unauthorized or untrained must
not perform any operations on it.
1.2 Restrictions for use
• Do not use the monitor and the SpO
2
sensor during magnetic resonance imaging (MRI). Induced current
could cause burns.
• Operating high frequency electrosurgical equipment in the vicinity of the monitor may produce
interference and cause incorrect measurements.
• The following factors may influence the accuracy of SPO
2
measurements:
• exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light
source), bilirubin lamps, fluorescent lights, infrared heating lamps or direct sunlight (exposure to
excessive illumination can be corrected by covering the sensor with a dark or opaque material);
• the presence of an MRI device;
• excessive patient movement;
• intravascular dyes such as indocyanine green or methylene blue;
• significant levels of dysfunctional hemoglobin (such as carboxyhemoglobin or methemoglobin);
• incorrect sensor application or use;
• placement of a sensor on an extremity with a blood pressure cuff, arterial catheter or
intravascular line; and
• low perfusion.
• Do not use the SpO
2
sensor on the same limb being used for NIBP measurement. This may result in
inaccurate SpO
2
reading due to blocked blood flow during cuff inflation.
• Do not measure SpO
2
on a finger painted with nail polish. This may result in unreliable measurements.
▪ Do not measure NIBP on patients with sickle-cell disease or any condition in which skin damage has
occurred or is expected.
▪ Use clinical judgment to decide whether to perform frequent Auto BP measurements on patients with
severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff.
▪ Use clinical judgment to decide whether to perform Auto BP measurements on patients with
thrombasthemia.