En 60601-1 Classification; Emissions/Immunity - Delfi 9-2200-001BFR Operator's Maintenance Manual

Pts for blood flow restriction system
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GENERAL INFORMATION

EN 60601-1 CLASSIFICATION

Note: This device is not suitable for use in the presence of flammable anesthetic or gases.
Medical Equipment with respect to electrical shock, fire and mechanical hazards and electromagnetic compatibility only.
In accordance with CAN/CSA – C22.2 No. 60601:14, ANSI/AAMI ES60601-1:2005 and A2 (R)2012 and A1. Medical
Equipment with respect to electromagnetic compatibility only. In accordance with ANSI/AAMI/IEC 6060-1-2:2014.
Type of protection against electric shock
Degree of protection against electric
shock
Mode of operation
*When the unit is operating on backup battery, the type of protection against electric shock changes to
internally powered equipment

EMISSIONS/IMMUNITY

The Delfi PTS for BFR complies with EMC criteria set forth in EN 60601-1-2. The user of this device should be aware that
precautions should be taken in regards to EMC. The device should be installed and used according to the EMC
information provided in the instructions for use. See Electromagnetic Compatibility under Section 2 Operating
Instructions.
Cable
~ AC Power Mains power cord
WARNING:
use of an ~ AC Power Mains power cord with a length other than those specified may result in increased
emissions and decreased immunity
11
GENERAL INFORMATION
Class I or Internally Powered Equipment*
Type B applied part
Continuous operation
Maximum length
2.45 m (8 ft)
1

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