ASI Dental Specialties
2 – OPERATING ENVIRONMENT & CLASSIFICATION OF EQUIPMENT
www.asisupport.com
Page 1
65-0048 Rev-B (04/01/21)
CLASSIFICATION OF EQUIPMENT (EN-60601-1)
Type/Mode
Classification
Types of shock protection
Class I Equipment
Degree of shock protection
TYPE B and/or TYPE BF APPLIED PART depending on order configuration
Degree of protection against water ingress
ORDINARY EQUIPMENT
Mode of operation
Intermittent
Flammable Gasses:
Not suitable for use in the presence of a flammable anesthetic mixture with air,
oxygen, or nitrous oxide, where such gasses may accumulate in concentration
(closed spaces).
ENVIRONMENTAL SPECIFICATIONS
Temperature/Humidity
Specification
Storage/Transportation Temperature:
-40˚C to 70˚C (-40˚F to 158˚F) - Relative humidity 80%
Operating Temperature:
10˚C to 40˚C (40˚F to 104˚F) - Relative humidity 80%
Indoor Use:
Altitude up to 2,000M (6,563 ft.), installation category II, pollution degree 2. (UL
61010A-1 and CAN/CSA C22.2, No. 1010.1-92 only)
Exclusions
Hospitals except for near active HF surgical equipment and the RF shielded room of a
medical equipment system for magnetic resonance imaging, where the intensity of
electromagnetic disturbances is high.
ELECTROMAGNETIC COMPATIBILITY (EMC)
Although this dental equipment conforms to the intent of the 2004/108/EC EMC Directive, all medical
equipment may produce electromagnetic interference or be susceptible to electromagnetic interference. The
following are guidance and manufacturer’s declarations regarding EMC for this equipment.
This equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in the following pages.
⚠
⚠
WARNING
ELECTROMAGNETIC COMPATIBILITY
As with all electrical medical equipment, this equipment may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures such as re-orienting or relocating this equipment unit or shielding
the location.
•
Portable and Mobile RF communications equipment can affect the performance of this equipment,
and should be used no closer than 30cm (12inches) to any part of the ASI dental system. Please use
the guidelines and recommendations specified in IEC 60601-1-2, Edition 4.0.
•
Other medical equipment or systems can produce electromagnetic emissions and therefore can
interfere with the functionality of this equipment. Care should be used when operating the system
