Filter
Top Products
Class 1 Equipment: Equipment in which protection against electric shock does not
rely on basic insulation only, but includes a grounding pin on the power cord. For
ground reliability always plug the power cord into an AC grounded outlet.
Type BF Equipment: Type B piece of equipment with an F-Type applied part.
A Type B piece of equipment is one that provides a particular degree of protection
against electric shock, particularly regarding allowable leakage current and reliability
of the protective earth connection (grounding).
F-Type applied part is one that extends from the patient into the equipment and is
isolated from all other parts of the equipment.
Water Ingress: This device does not have protection against ingress of water.
Disinfection: With the exception of the patient circuit, this device can be disinfec-
ted using 70% isopropyl alcohol or equivalent. (See Section 6: Cleaning and
Disinfection.)
Flammable Anesthetics: This device is not suitable for use in the presence of a
flammable anesthetic mixture with air, or in the presence of a flammable anesthetic
mixture with oxygen or nitrous oxide.
Intermittent Operation: This device is designed for Intermittent Operation Only
and not for continuous use. The device should not be cycled continuously for more
than 5 minutes. After such time, the unit should either be turned off or left idling with
the blower on for at least 5 minutes.
EQUIPMENT CLASSIFICATION
Per IEC 60601-1, Medical Electrical Equipment, General Requirements for Safety, the
CoughAssist MI-E is classified as follows:
SECTION 2
WARNINGS AND
C AUTIONS
3
92804 3/28/01 8:35 AM Page 5