Miscellaneous; Emc; Classification; Environmental Storage / Transit Conditions - Arjo FIRST STEP Instructions For Use Manual

Miscellaneous

EMC

First Step Select Therapy System uses RF energy only for its internal function. Therefore, its RF emissions are very low
and are not likely to cause interference in nearby electronic equipment. The First Step Select Therapy System was tested
to the following standard.
• IEC 60601-1-2 Issued: 2007/03/30 Ed:3 Medical electrical equipment - Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility - Requirements and tests
• Class II (UL 60601-1)
• Type BF Applied Part
•
• Not for Use with Flammable Anesthetic Mixture with Air, Oxygen or Nitrous Oxide.
• Continuous Operation
• Ordinary Equipment

Environmental Storage / Transit Conditions

Relative Humidity Range: 10% to 90%
Atmospheric Pressure Range: 500 hPa to 1060 hPa

Environmental Operating Conditions

Relative Humidity Range: 10% to 95%
Atmospheric Pressure Range: 500 hPa to 1060 hPa
This product is double insulated (Class II). It is constructed with two completely independent electrical insulation systems.
unit.
Standards (UL60601-1, IEC60601-1, and EN60601-1) and are labeled accordingly. Each box of the designation label
(see Symbols Used
devices. Per the Medical Electrical Equipment Standard (UL60601-1), the manufacturer, Underwriters Laboratories
Double Insulation (Class II). Refer to electrical standards UL60601-1, IEC 60601-1 or EN 60601-1, Clause 19 and ANSI/
AAMI ES1:1993.

Ground Continuity Testing

Double Insulated products (normally ungrounded apparatus) rely on two independent electrical insulation systems that
are isolated from metal parts. Ground continuity is not required.
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