Belmont FMS2000 - Alarm States and Controls; Safety Agency Approvals & Classifications

2. Technical Specifications
2-10
ALARM STATES and
CONTROLS
ALARM MESSAGES
Operator Setting, User-
correctable
MISSING DISPOSABLE
DOOR OPEN
FLUID OUT
AIR DETECTION
HIGH PRESSURE
System Status LOW BATTERY
System Failures
AIR DETECTOR FAULT
PUMP FAULT
VALVE FAULT
HEATER FAULT LATCH
HEAT POWER READ BACK FAULT
HEATER OVER POWER FAULT
POWER MODULE OVERTEMP
HEATING FAULT
WATCHDOG
OVER TEMP
SAFETY AGENCY
APPROVALS &
CLASSIFICATIONS
Type of Protection Against
Electric Shock
Class I, or internally powered
Degree of Protection
Against Electric Shock
CF defibrillator-proof
Degree of Protection
Against Harmful Ingress of
Water
IPX2, Drip proof
Method of Sterilization
Disposable delivered sterile, single use
Degree of Safety in
Presence of Flammable
Anesthetics
Not suitable
Mode of Operation
Continuous
Medical Equipment
UL 60601-1
CAN/CSA-C22.2 No. 601.1
ANSI/AAMI/ES60601-1 (2005)
CAN/CSA-C22.2 No. 60601.1 (2008)
Medical – General Medical Equipment
As to electrical shock, fire and mechanical hazards
only in accordance with
UL 60601-1,
CAN/CSA-C22.2 No. 601.1,
ANSI/AAMI/ES60601-1 (2005, 3
rd
ed.),
CAN/CSA
-
C22.2 No. 60601
-
1 (2008)
Medical Device Directive:
Council Directive
93/42/EEC
Hardware: Class IIb
Disposable Set: Class IIa