Masimo Testeur RD SedLine Mode D'emploi page 2

RD SedLine Tester
Reusable
PURPOSE
The RD SedLine™ Test Tool connects in place of the RD SedLine EEG sensor and allows testing of basic function and
patient safety of the SedLine® system.
The SedLine® system consists of 3 distinct components:
• A base monitor and display device (e.g. The Masimo® Root® Monitor).
• The SedLine Module, which connects to the monitor.
• The RD SedLine patient cable, which connects the SedLine module to the RD SedLine EEG Sensor.
Safety testing of the base monitor should be performed in accordance with the maintenance or service procedures for
that device. These instructions describe the additional tests required to verify the functional and safety characteristics
of the SedLine Module and RD SedLine patient cable.
WARNINGS, CAUTIONS AND NOTES
• The Tester should be free of visible defects. Never use a damaged product, or one with an open enclosure shell
or exposed electrical contacts.
• Failure to properly connect the Tester to the device or patient cable will result in intermittent readings,
inaccurate results or no reading.
• Functional Testers cannot be used to assess accuracy.
• The Tester is not to be used as a calibration tool.
INSTRUCTIONS
A. Functional Test
1. Connect the SedLine Module to the base monitor and attach the RD SedLine Patient Cable to the
SedLine Module.
2. Set the monitor to display SedLine monitoring window on Root® or alternative monitoring device (consult the
monitor instruction manual if necessary).
3. Connect the RD SedLine Test Tool to the patient cable. Verify the following:
a. All electrodes show good connected status, and impedance in the range of 4.5 to 5.5 kΩ.
b. Adjust the EEG amplitude to 1 µV/mm observe for flat trace signals with approximately 2 mm peak-to-peak
baseline noise.
Failure to achieve these results may indicate a defect in the SedLine Module or patient cable.
B. Safety Test (Leakage Current)
1. Verify that the base monitor itself has passed safety testing in accordance with its maintenance/service
documentation.
2. Connect the SedLine Module to the base monitor, and attach the RD SedLine Patient Cable.
3. Connect the RD Sedine Test Tool to the patient cable.
4. The wire terminal on the RD SedLine Test Tool represents the "Applied Part". For purposes of this safety test, the
RD SedLine EEG Sensor is considered to be a single applied part. Connect the wire terminal to an appropriate
"Applied Part" terminal of a medical safety analyzer or leakage tester. (On many testers, this may be an ECG
electrode terminal, such as RL. Consult the analyzer/tester instruction manual if required.)
5. Follow the operating instructions for the analyzer/tester to perform a patient applied part leakage current test.
The following power conditions should be tested:
a. Normal Polarity: Normal, Open Neutral, Open Earth (Ground)
b. Reverse Polarity: Normal, Open Neutral, Open Earth (Ground)
Verify that the leakage current is less than 10 μA for all cases.
6. Follow the operating instructions for the analyzer/tester to perform a mains on applied part leakage current
test. The following power conditions should be tested:
a. Normal Polarity
b. Reverse Polarity
Verify that the leakage current is less than 20 μA for all cases.
7. Remove the tester from the device or cable.
D IREC TIO N S FO R US E
LATEX
Not made with natural rubber latex
PCX-2108A
02/13
2
en
Non-sterile
10126B-eIFU-0419