Mindray V Series - Indications for Use; Applied Parts

V Series Operating Instructions xxvii
Indications for Use Introduction
Indications for Use
The V Series Monitoring System is intended for intra hospital use under the direct supervision of a
licensed healthcare practitioner.The Indications for Use for the V 12/V 21 include the continuous
monitoring of the following human physiological parameters:
• ECG waveform derived from 3, 5 and 12 lead measurements
• Heart Rate
• ST Segment Analysis
• Arrhythmia Detection
• 12-lead ECG interpretation
• QT Analysis
• Pulse Oximetry (SpO
2
)
• Pulse Rate (PR)
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP)
• Cardiac Output (C.O.)
• Respiratory Gases (O
2
, CO
2
)
• Respiration Rate (RESP)
• Anesthetic Gases (Iso, Enf, Sev, Hal, Des, N
2
O)
• Temperature ( TEMP)
• Bispectral Index (BIS)
The V 12/V 21 Monitor has the capability of performing IV Drug and Hemodynamic Calculations and
interfacing with network devices.
The target populations are adult, pediatric and neonate with the exception of:
• Arrhythmia detection, ST Segment Analysis and QT Analysis, for which the target populations are
adult and pediatric only,
• IV Drug Calculations for which the target population is adult only
• Cardiac Output for which the target population are adult and pediatric only, and
• Bispectral Index (BIS) for which the target population are adult and pediatric only.
Applied Parts
The applied parts of the V 12/V 21 are:
• ECG electrodes and leadwire,
• SpO
2
sensor and cable,
• NIBP tubing and cuff,
• Temp probes and cable,
• IBP/ICP transducer and cable,
• C.O. sensor and cable,
• CO
2
watertrap, mask, and sampling line,
• BIS sensor