HYPERICE Normatec 3, Operating Instructions Manual

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• Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
• Avoid exposure to known sources of EMI (electromagnetic interference) such as
diathermy, lithotripsy, electrocautery, RFID (Radio Frequency Identification), and
electromagnetic security systems such as anti-theft/electronic article surveillance
systems, metal detectors. Note that the presence of RFID devices may not be
obvious. If such interference is suspected, reposition the equipment, if possible,
to maximize distances.
ELECTROMAGNETIC EMISSIONS
This equipment is intended for use in the electromagnetic environment of clinics, hospitals,
athlete training, or home environments. The user of this equipment should assure that it is used
in such an environment.
Emissions
Compliance
According
To
Electromagnetic Environment
RF emissions
(CISPR 11)
Group 1 The equipment 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.
CISPR emissions
classification
Class B The equipment is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage charger network
that supplies buildings used for domestic
purposes.
Harmonic emissions
(IEC 61000-3-2)
Class A
Voltage fluctuations/
flicker (IEC 61000-3-3)
Complies
ELECTROMAGNETIC IMMUNITY
During the immunity testing described below the Normatec 3 continued to provide therapy
normally. 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
Compliance
Level (of this
control unit)
Electromagnetic Environment
Electrostatic
discharge, ESD
(IEC 61000-4-2)
± 8 kV Direct
± 2,4,8,15 kV 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.
Electrical fast
transients/
bursts (IEC
61000-4-4)
± 2 kV Mains power quality should be that of a typical
clinic, hospital, athletic training, or home
environment.
RF Proximity
(IEC 61000-4-3)
27 V/m 28 V/m
9 V/m 28 V/m
28 V/m 28 V/m
9 V/m
Equipment with high RF emissions should be
kept at a distance to reduce the likelihood of
interference.
Surges on AC
mains lines (IEC
61000-4-5)
± 1 kV Mains power quality should be that of a typical
clinic, hospital, athletic training, or home
environment.
Power frequency
magnetic field
50/60 Hz (IEC
61000-4-8)
30 A/m Equipment that emits high levels of power line
magnetic fields (in excess of 3A/m) should be
kept at a distance to reduce the likelihood of
interference.