ergoline ergoselect 4, Руководство оператора

Страница: 26 / 96

5 Applied Parts
24 ergoselect 4 / 5
5.3.2 Intended Purpose
The ergoline SpO2 pulse oximetry module is used for the
non-invasive measurement of functional oxygen saturation
in human arterial blood (SpO2) at rest and during dynamic
exercise.
The medical device is intended for use in professional
healthcare institutions for inpatient and outpatient care.
The signal is acquired on the intact skin of adult patients.
5.3.3 Safety Information
The following factors may have an influence on the accu-
racy of the oxygen saturation readings:
• interference from electrosurgical devices
• arterial catheter, blood pressure cuffs, intravascular line, etc.
• moisture in the sensor
• incorrect sensor application
• wrong sensor type
• weak pulse
• venous pulsations
• anemia or low hemoglobin concentrations
• arterial dyes
• artificial fingernails and dark nail polish
The SpO2 module is not designed for operation in the
vicinity of MRT, NMRI or X-ray systems and may not be
used in such environments.
Measurements taken at the wrong site or with the wrong
type of sensor may cause it to incorrectly measure SpO2.
The sensor cable may strangulate parts of the body or the
finger clip sensor may cause skin integrity problems, etc.
Only sensors and accessories approved by ergoline may be
combined with the SpO2 module. Sensors and accessories
must be in perfect condition. Using other sensors and
accessories may adversely affect the proper functioning
and cause biocompatibility issues.
Taking medicine or other preparations which change blood
color, the administration of intravascular dyes (e.g, methy-
lene blue or indocyanine green) as well as significant levels
of dysfunctional hemoglobin may considerably falsify the
measurements.