Halyard CO LIEF PMG-Basic

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Figure 8-2 Set Power vs. Output Power

8.16 IEC Electrical Safety and EMC Specications

Table 8-1 IEC Electrical Safety Specications

Device Description

Class I, Debrillation proof Type CF Equipment, IPX0, not AP/APG

Mode of Operation: Continuous

Electrical Isolation • Leakage current conforms to IEC 60601-1

• Dielectric withstanding voltage conforms to IEC 60601-1

EMC Emissions and Susceptibility: The HALYARD* Pain Management System has been tested and found to comply with the limits for medical devices to the IEC 60601-1-

1-2:2007-03. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This system generates, uses, and can

radiate radiofrequency energy and, if not installed and used in accordance with the instruction given below, may cause harmful interference to other devices in the vicinity.

However, there is no guarantee that interference will not occur in a particular installation. Portable and mobile RF communications equipment can aect medical electrical

equipment.

Table 8-2 IEC EMC Specications (Emissions)

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The HALYARD* Pain Management System is intended for use in the electromagnetic environment specied below. The customer or the user of the HALYARD* Pain

Management System should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment – Guidance

RF emissions

CISPR 11

Group 1 The HALYARD* Pain Management System must emit electromagnetic energy in order to perform its

intended function. Nearby electronic equipment may be aected.

RF emissions

CISPR 11

Class A The HALYARD* Pain Management System is suitable for use in all establishments other than domestic and

those directly connected to the public low-voltage power supply network that supplies buildings used for

domestic purposes.

Harmonic emissions