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2 Equipment Introduction
2.1 Intended Use
The VS 9/VS 9A/VS 9C/VS 8/VS 8A/VS 8C Vital Signs Monitors are intended for
monitoring, displaying, reviewing, storing, alarming, and transferring of multiple
physiological parameters including Temperature (Temp), Pulse Oxygen Saturation
(SpO
2
), Pulse Rate (PR), Respiration Rate (RR), Non-invasive Blood Pressure (NIBP), Carbon
Dioxide (CO
2
). All the parameters can be monitored on single adult, pediatric, and
neonatal patients.
The monitors are to be used in healthcare facilities by clinical professionals or under their
guidance. They should only be used by persons who have received adequate training in
their use. VS 9/VS 9A/VS 9C/VS 8/VS 8A/VS 8C Vital Signs Monitors are not intended for
helicopter transport, hospital ambulance, or home use.
• According to the conclusion of clinical evaluation and residual risk
evaluation, for the intended patients, there is no known side effects that can
occur during or after the use of the medical device. And there is no need for
the operator to make extra preparations. Thus, no residual risk associated
with using the medical device should be disclosed due to the risk
management report.
2.2 Intended Users
The VS Series Monitors are to be used in healthcare facilities by clinical professionals or
under their guidance. They should only be used by persons who have received adequate
training in their use.
2.3 Intended patient population
The VS 8/VS 8A/VS 8C/VS 9/VS 9A/VS 9C Vital Signs Monitors are applicable for single
adult, pediatric, and neonatal patients.
2.4 Intended Medical conditions
The VS Series Monitors are expected to be used in medical institutions, and its
application fields include: emergency care, internal medicine and surgical care, neonatal
care, elderly care, Ambulance Surgical Center, postoperative recovery, Physician Office.
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