Maxtec Handi+ Instrucciones De Uso página 6

10.0 ELECTROMAGNETIC COMPATABILITY
The information contained in this section (such as separation distances) is in general specifically written with regard to the Handi+. The numbers provided will not guarantee faultless operation
but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference.
Note: Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information
provided in this document and the remainder of the instructions for use this device.
Portable and mobile RF communications equipment can affect medical electrical equipment.
Cables and accessories not specified within the instructions for use are not authorized. Using other cables and/or accessories may adversely impact safety, performance and electromagnetic
compatibility (increased emission and decreased immunity).
Care should be taken if the equipment is used adjacent to or stacked with other equipment; if adjacent or stacked use is inevitable, the equipment should be observed to verify normal operation
in the configuration in which it will be used.
ELECTROMAGNETIC EMISSIONS
This equipment is intended for use in the electromagnetic environment specified below.
The user of this equipment should assure that it is used in such an environment.
EMISSIONS
RF Emissions (CISPR 11)
CISPR Emissions Classification
Harmonic Emissions
(IEC 61000-3-2)
Voltage Fluctuations
ELECTROMAGNETIC IMMUNITY
This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that it is used in such an environment.
IMMUNITY AGAINST
Electrostatic discharge, ESD (IEC 61000-4-2)
Electrical fast transients / bursts (IEC 61000-4-4)
Surges on AC mains lines (IEC 61000-4-5)
3 A/m power frequency magnetic
field 50/60 Hz (IEC 61000-4-8)
Voltage dips and short interruptions on
AC mains input lines (IEC 61000-4-11)
ENGLISH
COMPLIANCE ACCORDING TO ELECTROMAGNETIC ENVIRONMENT
Group 1 The Handi+ uses RF energy only for its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby electronic equipment.
Class A The Handi+ is suitable for use in all establishments other than domestic and those directly connected
to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Class A
NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally
Complies
required) this equipment might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
IEC 60601-1-2: (4TH EDITION) TEST LEVEL
Professional Healthcare
Facility Environment
Contact discharge: ±8 kV
Air discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV
Power supply lines: ±2 kV
Longer input / output lines: ±1 kV
Common mode: ±2 kV
Diferential mode: ±1 kV
30 A/m
50 Hz or 60 Hz
Dip>95%, 0.5 periods
Dip 60%, 5 periods
Dip 30%, 25 periods
Dip >95%, 5 seconds
ELECTROMAGNETIC ENVIRONMENT
Home Healthcare Environment
Floors should be wood, concrete, or ceramic tile. If floors are covered
with synthetic material, the relative humidity should be kept at
levels to reduce electrostatic charge to suitable levels.
Mains power quality should be that of a typical commercial or
hospital environment.
Equipment which emits high levels of power line magnetic fields
(in excess of 30A/m) should be kept at a distance to reduce the
likelihood of interference.
If user requires continued operation during power mains
interruptions, ensure that batteries are installed and charged.
Ensure that battery life exceeds longest anticipated power
outages or provide an additional uninterruptible power source.
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