Safety Tests - Nellcor OxiMax N-600x Service Manual

Performance Verification

Safety Tests

46
The N-600x safety tests meet the standards of, and are performed in accordance
with the IEC 60601-1 (EN 60601-1, Amendment 1, Amendment 2,) and UL
2601-1, for instruments classified as Class 1 and TYPE BF and ANSI/AAMI
Standard ES1.
Applicable tests for these standards are listed below. Technicians must be familiar
with the standards applicable to their respective institution and country. Test
equipment and its application must comply with the applicable standards:
• Ground Integrity on page 124 for test value.
• Earth Leakage Current on page 124 for test values.
• Enclosure Leakage Current on page 124 for test values.
• Patient Applied Risk Current on page 125 for test values.
Note: Patient Applied Risk Current and Patient Isolation Risk Current: The
leakage test lead from the test equipment must be connected to the
N-600x %SpO
2
using a male 9-pin "D" type connector with all pins shorted together.
During these tests, the monitor displays the following message:
"RECONNECT/REPLACE SENSOR".
Sensor Port through the DOC-10 pulse oximetry cable