Bolder Surgical
en - CoolSeal™ Generator
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Technical Specifications ...........................................................................................................................25
Input Frequency.................................................................................................................................................................25
Input Current ......................................................................................................................................................................25
Backup Power ......................................................................................................................................................................25
Equipotential Connection ...........................................................................................................................................25
Duty Cycle .............................................................................................................................................................................25
Low Frequency (50/60 Hz) Leakage Current ....................................................................................................25
Standards and IEC Classifications ............................................................................................................................25
Symbols ..........................................................................................................................................................26
Classifications ...............................................................................................................................................27
Class I Equipment (IEC 60601-1) ..............................................................................................................................27
Electromagnetic Compatibility (IEC 60601-1-2) .............................................................................................27
Type CF Equipment (IEC 60601-1) ..........................................................................................................................27
IP XX Liquid Ingress/Spillage (IEC 60601-1 and IEC 60601-2-2) ............................................................27
Voltage Transients – Energy Platform Mains Transfer (IEC60601-1 and IEC 60601-2-2) .........27
Electromagnetic Compatibility (IEC 60601-1-2 and IEC60601-2-2) ...................................................27
Output Characteristics ..............................................................................................................................27
Maximum Output for the CoolSeal
™
Generator .............................................................................................27
Electromagnetic Immunity .........................................................................................................................................28
Appendix A – Periodic Functional Test ...............................................................................32
Definitions .............................................................................................................................................................................32
Equipment Required: ......................................................................................................................................................32
Pass/Fail Criteria: .................................................................................................................................................................32
Procedure: .............................................................................................................................................................................33
Periodic Functional Test Summary Form ................................................................................................................36
Warranty ................................................................................................................................38
