Miscellaneous; Emc; Environmental Storage / Transit Conditions; Environmental Operating Conditions - arjo First Step Select Manuel D'utilisation

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
Classi cation
Classi cation in accordance with UL 60601-1, CSA C22.2 No 601.1 and IEC. 60601-1
• Class II (UL 60601-1)
• Type BF Applied Part
• No Sterilization
• Not for Use with Flammable Anesthetic Mixture with Air, Oxygen or Nitrous Oxide.
• Continuous Operation
• Ordinary Equipment

Environmental Storage / Transit Conditions

Temperature Range: -20 to 60 C (-4 to 140 F)
Relative Humidity Range: 10% to 90%
Atmospheric Pressure Range: 500 hPa to 1060 hPa

Environmental Operating Conditions

Temperature Range: 10 to 40 C (50 to 104 F)
Relative Humidity Range: 10% to 95%
Atmospheric Pressure Range: 500 hPa to 1060 hPa

Leakage Testing and Ground Continuity Testing

This product is double insulated (Class II). It is constructed with two completely independent electrical insulation systems.
The power cord is not used to ground the unit. Grounding is not required. The unit shall not be modi ed to ground the
unit.
Arjo products certi ed as Double Insulated (Class II) meet the requirements of the Medical Electrical Equipment
Standards (UL60601-1, IEC60601-1, and EN60601-1) and are labeled accordingly. Each box of the designation label
(see Symbols Used) symbolizes the two independent insulation systems.

Leakage Testing

Double Insulated electrical devices (normally ungrounded apparatus) must be tested differently than other electrical
devices. Per the Medical Electrical Equipment Standard (UL60601-1), the manufacturer, Underwriters Laboratories
Inc. and other test organizations, all parties interested in testing for current leakage shall use the Methods identi ed for
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
32
required.