Patient Safety; Indications And Usage - Novametrix Medical Systems 515B User Manual

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Indications and Usage

Rev. 02

Patient Safety

Pulse oximetry is a non-invasive method of monitoring the oxygen saturation of arterial blood.
Pulse oximeters display oxygen saturation of functional hemoglobin and therefore the accuracy
may be interfered with by carboxyhemoglobin or other dyshemoglobins present in significant
concentrations. Oxygen saturation monitoring is intended to be used in a variety of clinical
situations, including, but not limited to respiratory therapy, anesthesia, intensive care, and
emergency.
The Model 515B/C Pulse Oximeter has electrically isolated inputs. Patient leakage current
flowing from the instrument to ground is limited to less than 10 µA at 120 V, 60 Hz. Patient
isolation is greater than 10 MΩ, 2500 V rms at 60 Hz. For maximum patient and operator safety,
the following procedures are recommended;
• Failure of Operation: If the monitor fails to respond as described, do not use until the
situation has been corrected by qualified personnel.
• Keep the monitor and its accessories clean.
• Do not operate the monitor when it is wet due to spills or condensation.
• Do not operate the monitor if it appears to have been dropped or damaged.
• Connect the line cord only to a grounded hospital grade outlet. The Model 515B/C
should be connected to the same electrical circuit as other equipment in use on the
patient. Outlets on the same circuit can be identified by the hospital's engineering
department.
The Model 515B/C is intended to be used for monitoring functional oxygen saturation and
pulse rate in circumstances where it is desirable to monitor patient oxygenation. The monitor is
designed to monitor all patients including adult, pediatric, and neonatal. The Model 515B/C is
not intended for any other purpose.
NOTE: Components of this product and its associated accessories which may have patient
contact are free of latex.
Model 515B/C User's Manual
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