TuffSat User’s Guide and Service Manual
4-2
Electromagnetic compatibility (EMC)
The TuffSat pulse oximeter complies with the requirements of EN 60601-1-2:
Electromagnetic compatibility – Requirements and tests.
Emissions:
EN 55011 Group I, Class B
The oximeter was tested at room temperature while operating on battery power
using alkaline batteries.
Electromagnetic effects
Electromagnetic interference, including interference from portable and mobile
radio frequency (RF) communications equipment, can affect this monitor.
Indications that the oximeter is experiencing electromagnetic interference include
the following:
•
Variations in the display (pleth bar does not correlate to physiological signals).
•
Sudden increases or decreases in the pulse strength indicator that do not
correlate to the physiological condition of the patient.
•
Dashed messages that are not resolved by the instructions found in this
manual
when a valid physiological signal is present.
This interference may be intermittent and careful correlation between the effect
and its possible source is important. Indications of interference should not occur if
the monitor is used within its intended electromagnetic environment.
Software safety checks
The Datex-Ohmeda software design controls include performance of a risk analysis
using methods consistent with EN 1441 Medical devices – Risk analysis.
The TuffSat oximeter employs a watchdog timer, self-monitoring activities (stack
check, range check of inputs, etc.), and power-on self-tests (display checks and
calibration verification). The software continuously monitors the sensor and, if a
failure is detected, discontinues power to the sensor.
Summary of Contents for TuffSat
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