Bard ENCOR ENSPIRE Instrucciones De Uso página 8

SPECIFICATIONS
System Power Ratings
Electrical Conformity
Nominal Ratings
Voltage/Frequency
Current
VA (Calculated)
Power factor
Electromagnetic Emissions and Immunity
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information
provided below.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
The E C E
N OR NSPIRE
TM
Breast Biopsy System should ensure that it is used in such an environment.
Emissions Test
RF Emissions Group 1, Class A
CISPR 11
Harmonics IEC Class A - Complies
61000-3-2
Flicker Complies
IEC 61000-3-3
The E C E
N OR NSPIRE TM
Breast Biopsy System should ensure that it is used in such an environment.
Immunity Test
The E C E
N OR NSPIRE
TM
Breast Biopsy System should ensure that it is used in such an environment.
Class I, Type BF equipment.
Standby
115 VAC ~ 50/60 Hz
230 VAC ~ 50/60 Hz
Guidance and Manufacturer's Declaration – Emissions
Guidance and Manufacturer's Declaration - Emissions
Compliance
The E C E
N OR NSPIRE
RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The E C E
N OR NSPIRE
and those directly connected to the public low-voltage power supply network that supplies buildings used
for domestic purposes.
Guidance and Manufacturer's Declaration – Immunity
Guidance and Manufacturer's Declaration – Immunity
EN/IEC 60601 Test Level
±2kV, ±4kV, ±6kV Contact discharge
±2kV, ±4kV, ±6kV, ±8kV Air discharge
±1kV Differential
±2kV Common
>95% Dip for 0.5 Cycle
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
Guidance and Manufacturer's Declaration – Emissions
Equipment and Systems that are NOT Life-supporting
Guidance and Manufacturer's Declaration – Emissions
Nominal Ratings
Voltage/Frequency
4 Current
600 VA (Calculated)
450
0.75 Power factor
All Equipment and Systems
Electromagnetic Environment – Guidance
Breast Biopsy System uses RF energy only for its internal function. Therefore, its
TM
Breast Biopsy System is suitable for use in all establishments, other than domestic,
TM
All Equipment and Systems
Compliance
Level
Pass
Pass Mains power quality should be that of a typical commercial or
hospital environment.
Pass Mains power quality should be that of a typical commercial or
hospital environment.
Pass Mains power quality should be that of a typical commercial or
hospital environment. If the user of the E
Pass
Biopsy System requires continued operation during power mains
interruptions, it is recommended that the E
Pass
Biopsy System be powered from an uninterruptible power supply or
Pass battery.
Pass
commercial or hospital environment.
6
Operating
115 VAC ~ 50/60 Hz
230 VAC ~ 50/60 Hz
4
600
450
0.75
Electromagnetic Environment – Guidance
C E
N OR
C
N OR
C E
N OR NSPIRE
TM
C E
N OR NSPIRE
TM
TM Breast
NSPIRE
TM
E Breast
NSPIRE
C E
N OR NSPIRE
TM