Appendix A - Periodic Functional Test; Important; Definitions; Equipment Required - Bolder Surgical CoolSeal Generator Instrucciones De Uso

Appendix A – Periodic Functional Test
The purpose of the test is to confirm proper function of the CoolSeal
performed at least every two years to ensure proper function is maintained over time. Refer to the final test date label
for the last Bolder Surgical
Warning
Do not open the case of the CoolSeal
required to confirm safe operation is maintained once the case has been opened. This testing is only available at the
Bolder Surgical
Notice
Only qualified individuals should conduct the CoolSeal

Important

An optional form is supplied below to record the results of the Periodic Functional Test.
Warning
Do not attempt to use the Functional Test Cable for any purpose other than the steps outlined herein.
Do not use clinically.

Definitions:

UUT – Unit Under Test
ESA – Electrical Safety Analyzer
ESuA – Electro-Surgical Analyzer

Equipment Required:

UUT - CoolSeal Generator – CSL-200-50
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ESA - Fluke Electrical Safety Analyzer Model ESA612 (or equivalent)
ESuA - Fluke Electro-Surgical Analyzer Model QA-E SII, QA-ES III (or equivalent)
Functional Test Cable – CSL-FTC
Stopwatch

Pass/Fail Criteria:

• Follow the steps outlined below to obtain the indicated result, repeat if this result is not obtained.
• Contact Bolder Surgical to arrange for service in order to resolve failures or anomalies.
• Do not attempt to repair the CoolSeal
• Attempting to repair the CoolSeal
Bolder Surgical
functional test date. This test may be used more frequently as required by hospital policies.
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Generator. There are no serviceable items within the case. Additional testing is
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Service Center. Failure to comply may result in an increased risk of electrical shock.
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Generator.
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Generator will violate the product warranty.
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Generator. It is recommended that this test be
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Functional Test.
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en - CoolSeal™ Generator