Performance Verification Procedures 5: Performance Verification
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Paddles Safety Check
This section describes how to test the paddles to ensure they are connected correctly. This test checks the
Patient Contact Indicator (PCI) function of the paddles. The PCI measurement is used to detect Pads
Off and Paddles Off, and to illuminate the PCI LEDs on PCI-equipped paddle sets. If all results are as
described, the device passes that portion of the test.
NOTE: Test internal paddles (IEC Type CF) only if the device is used for internal defibrillation.
1 Connect a set of external paddles to the device.
a Make sure the metal surfaces of the paddles and slide-on adapters are clean and dry. Also make
sure the slide-on adapters are clean, shiny, and making good contact to the paddle surface.
b Put the paddles in the paddle tray.
2 Tu r n th e Th er a py Kn o b t o Monitor.
3 Verify that the PCI is not lit.
4 Take one paddle out of the paddle tray.
5 Verify that one red LED of the PCI flashes.
6 Take both paddles from the paddle tray and hold them firmly together, face to face (metal to metal).
Be sure the paddles are clean and are making good contact with one another.
7 Verify that all LEDs on the PCI are lit.
Safety Tests
This section discusses tests of the HeartStart XL+’s electrical safety. The Philips Safety Test designation
for each test is provided for reference of Philips service personnel.
Test Notes
HeartStart XL+ complies with the international electrical safety standards:
– IEC 60601, Medical Electrical Equipment, General Requirements for Safety, and
– IEC 62353, Medical Electrical Equipment, Recurrent Test and Test After Repair of Medical
Electrical Equipment.
To successfully complete HeartStart XL+ safety testing, please note the following:
• Use the procedures called out by the manufacturer of the safety analyzer in use.
• Only test the AC Mains (line) voltage used in the customer’s facility — there is no need to test both
120 V AC and 240 V AC.
• Test both Normal and Reverse Polarity line connections for each test, and record the worst case value.
• If a chassis reference point is needed for the testing, connect to the inside metal shaft on the ECG
Out (Sync) jack. (This is not earth ground).
• Insert a battery charged to at least 20% before performing safety tests.
Test Method
The HeartStart XL+ does not have an earth ground node that could be used for protective earth
continuity testing purposes. The only accessible earth ground node is at the AC inlet on the AC power
module. All accessible parts of HeartStart XL+ are protected from mains by double or reinforced
insulation. Therefore the tests IEC 60601: 8.6.2 “Protective Earth Terminal” and IEC 62353:
“Protective Earth Resistance” are not applicable.
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