Classifications; Class I Equipment (Iec 60601-1); Electromagnetic Compatibility (Iec 60601-1-2); Type Cf Equipment (Iec 60601-1) - Bolder Surgical CoolSeal Generator Instrucciones De Uso

Classifications

Class I Equipment (IEC 60601-1)

Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they
are connected to the protective earth conductor.

Electromagnetic Compatibility (IEC 60601-1-2)

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operation.

Type CF Equipment (IEC 60601-1)

This generator provides a high degree of protection against electric shock, particularly regarding allowable leakage currents.
It is type CF isolated (floating) output and may be used for procedures involving the heart.

IP XX Liquid Ingress/Spillage (IEC 60601-1 and IEC 60601-2-2)

The CoolSeal Generator is constructed so that liquid spillage in normal use does not wet electrical insulation or other
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components which when wetted are likely to adversely affect the safety of the equipment.
Voltage Transients – Energy Platform Mains Transfer (IEC60601-1 and IEC 60601-2-2)
The CoolSeal ™ Generator continues to operate normally with no errors or system failures when transfer is made between line
AC and an emergency energy platform voltage source. (IEC 60601-1- 2)

Electromagnetic Compatibility (IEC 60601-1-2 and IEC60601-2-2)

The CoolSeal Generator complies with the appropriate IEC 60601-1-2 and 60601-2-2 specifications regarding
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electromagnetic compatibility.
Warning
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify
that they are operating normally.
Portable RF communication equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30cm (12 inches) to any part of the CoolSeal by Bolder Surgical. Otherwise, degradation of the performance of this equipment could result.

Output Characteristics

Maximum Output for the CoolSeal
Power readouts agree with actual power into rated load to within 20% or 5 watts, whichever is greater.
Open Circuit Peak
Voltage (max)
190 V
Bolder Surgical
Generator
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Rated Load Rated Output
Power (max)
20 Ω 50 W
Crest Factor
1.9
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Generator including cables specified
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Waveform Duty
Cycle
100%
en - CoolSeal™ Generator