Electromagnetic Compatability - Maxtec Handi+ Instructions For Use Manual

10.0 ELECTROMAGNETIC
COMPATABILITY
The information contained in this section (such as separation distances) is in general specifi-
cally 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 sus-
ceptible 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 infor-
mation 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 electromag-
netic 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.
COMPLIANCE
EMISSIONS ACCORDING
TO
RF Emissions Group 1
(CISPR 11)
CISPR Emissions Class A
Classification
Harmonic Emissions Class A
(IEC 61000-3-2)
Voltage Fluctuations Complies
ENGLISH
ELECTROMAGNETIC ENVIRONMENT
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.
The Handi+ is suitable for use in all establish-
ments other than domestic and those directly
connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
NOTE: The EMISSIONS characteristics of this equip-
ment 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 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.
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 IEC 60601-1-2: (4TH
EDITION) TEST LEVEL
Professional
Healthcare
Facility
Environment
Electrostatic discharge, Contact discharge: ±8 kV
ESD (IEC 61000-4-2) Air discharge: ±2 kV,
±4 kV, ±8 kV, ±15 kV
Electrical fast Power supply lines: ±2 kV
transients / bursts Longer input / output
(IEC 61000-4-4) lines: ±1 kV
Surges on AC mains Common mode: ±2 kV
lines (IEC 61000-4-5) Diferential mode: ±1 kV
3 A/m power 30 A/m
frequency magnetic 50 Hz or 60 Hz
field 50/60 Hz
(IEC 61000-4-8)
Voltage dips and Dip>95%, 0.5 periods
short interruptions Dip 60%, 5 periods
on AC mains input Dip 30%, 25 periods
lines (IEC 61000-4-11) Dip >95%, 5 seconds
Recommended separation distances between portable and mobile
RF communications equipment and the equipment
RATED MAXIMUM Separation distance according to frequency
OUTPUT POWER OF of transmitters in meters
TRANSMITTER
150 kHz to 80 MHz
W
d=1.2/V1] √P
0.01 0.12
0.1 0.38
1 1.2
10 3.8
100
6
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.
80 MHz to 800 MHz
d=1.2/V1] √P
0.12
0.38
1.2
3.8
12 12
WWW.MAXTEC.COM • (800) 748-5355
800MHz to 2.5 GHz
d=2.3 √P
0.23
0.73
2.3
7.3
23