This document contains proprietary and confidential information of Integra LifeSciences Corporation. Integra’s confidential information may not be used, disclosed or reproduced without the prior wrien consent of Integra LifeSciences Corporation.
CUSA® Clarity System Service and Maintenance Manual Page 56 of 117 0645403-2-EN
Test Description Unit Acceptance Criteria
Equipment Leakage Current µA ≤ 500 µA
Table 7-5 Equipment Leakage Current Acceptance Criteria (Direct Method)
Test Description Unit Acceptance Criteria
Equipotential Earth Ground pin Ω ≤ 300 mΩ
Cartridge Door Ω ≤ 300 mΩ
Handpiece Socket Connector Ω ≤ 300 mΩ
Figure 7-2
3. Measure the Protective Earth Resistance for each connection listed below:
Table 7-4 Protective Earth Resistance Acceptance Criteria
4. Record values in the Electricial Safety Test Datasheet (IT0738A in Appendix A).
Measurements of Equipment Leakage Current
(a) TN-System (Direct Method)
1. Connect the Safety Analyzer directly to the main power source for a TN-System.
2. Connect the console to the main power socket of the Safety Analyzer.
3. Aached the crocodile clip from the Safety Analyzer lead (Applied Part module port 1) to the proximal end of the tip (without the flue) as
shown in the Figure 7-2.
4. Aached the test lead from the safety Analyzer lead (Applied Part module port 2) to the Equipotential Earth Ground pin of the console as
shown in the Figure 7-2.
5. Select Equipment Leakage Current measurement on the safety Analyzer.
6. Turn on the DUT and wait for the GUI to load.
7. Connect the handpiece, aspiration, irrigation tubing kit, waste canister, and other accessories to the console and cart.
8. Prime the irrigation tubing and perform a handpiece test.
9. On the DUT main menu, set up the system as follows:
• AMPLITUDE to 100%
• ASPIRATION to 100%
• IRRIGATION to 2ml/min
• TISSUE SELECT to OFF
10. Press down the footswitch pedal to achieve maximum stroke.
11. Obtain the Equipment Leakage Current measurement, and normalize the value according to Section 7.8.3 Normalization Instructions.
12. Record values in the Electrical Safety Test Datasheet (IT0738A in Appendix A).