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Chapter 4: Electrical Safety Testing
This chapter covers how to test the electrical safety of Rad-97. No internal adjustment or recalibration is required. These procedures should be done by authorized service
personnel only. These safety checks should be performed after battery replacement and TB-20 replacement. Safety checks should be performed at regular intervals or in
accordance with local and governmental regulations.
To test the performance of Rad-97 following repairs or during routine maintenance, follow the procedure outlined in this section. If Rad-97 fails any of the described tests,
discontinue its use and correct the problem before returning the unit back to the user.
The following procedures are performed to verify proper operation of the device and check for electrical safety after service procedures are complete. DO NOT dock or
connect any devices to Rad-97 before or during these procedures unless instructed to do so.
Electrical Safety Testing
General
This section describes in general the electrical safety testing methodologies that can be performed on the instrument to detect potential electrical safety hazards.
The testing referenced in this chapter is in accordance with IEC 60601-1, 3rd Edition standard.
Test Equipment Recommended
1. Electrical Safety Tester (NIST certified or equivalent)
2. Digital Multimeter
Electrical Safety Tests
The schematics presented in this section are based upon the IEC 60601-1, 3rd Edition standard. The schematics are provided to give a general idea of the test setup. The
actual configuration of the test setup may vary based on the Electrical Safety Tester being used.
Service Warning: Before starting the testing, it is important to place the device under test (DUT) on an insulating surface.
Service Warning: Refer to general safety considerations, warnings and cautions of the Electrical Safety Tester used before testing the DUT.
Service Warning: Follow the setup instructions provided as part for the Electrical Safety Tester’s operating instructions before starting testing.
Service Warning: Make sure that the Electrical Safety Tester and DMM are under calibration before starting the testing.
Verification of Electrical Outlet and Power Cable
1. Check ratings (Maximum Current, Maximum Voltage, and Maximum Power) of power outlet and confirm safety test can be performed on that particular outlet.
2. Check power outlet wiring is good and according to local electrical code standards.
3. Always use power supply cord supplied by Masimo Corporation
4. Check power supply cord for kinks or any kind of damages or anomalies and always check continuity of line, neutral and earth conductors if in doubt and replace
the power supply cord as necessary.
5. Accuracy of electrical safety testing performed is dependent on all the factors mentioned above in this section.
Device Classification per IEC-60601-1
Product Name Configuration Power Source Classification Type of Patient Protection
Rad-97
NOT connected to AC Power Battery Powered Internally Powered Type BF Applied Part
Connected to AC power AC Powered Class I Type BF Applied Part
The electrical safety tests mentioned below are applicable based on Classification and Type of Patient Protection.
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