Guidance and
manufacture’s
declaration
–
electromagnetic immunity
–
for ME EQUIPMENT and ME SYSTEMS that are notLIFE-SUPPORTING
Guidance and
manufacture’s
declaration
–
electromagneticimmunity
The Pro7 is intended for use in the electromagnetic environment specified below. The customer or the user of
Pro7 should assure that it is used in such an environment.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency rangeapplies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the Pro7 is used exceeds t
he applicable RF compliance level above, the Pro7 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the Pro7.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Immunity test
IEC 60601test
level
Complianc
e level
Electromagnetic environment
- guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the Pro7, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of thetransmitter.
Recommended separation distance
Conducted RF
IEC61000-4-6
3 Vrms
150 kHz to 80MHz
3 Vrms
Radiated RF
IEC61000-4-3
3 V/m
80 MHz to 2.5GHz
3 Vrms
80 MHz to 800MHz
800 MHz to 2.5GHz
Where P is the maximum output powerrating
of the transmitter in watts (W)according
to the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
a
should be less than the compliance level in each
frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
!
Electromagnetic Compatibility (EMC)
Precautions
The
pro7™
model is suitable for use in
all establishments, including domestic
establishments and those directly con
nected to the public low-voltage pow
er supply network that supplies buildi
ngs used for domestic purposes. Both
models have been tested against, and
have passed the applicable
requirements of relevant electromedical
standards, including EN60601-1-2:2007.
The pro7 model emits electromagnetic
energy to perform its intended function.
Nearby electronic equipment may be af
fected by this emission.Similarly
the pro7 model may be affected by el
ectromagnetic emissions from other e
quipment in thevicinity.
The pro7 model is intended for use in the
electromagnetic environment specified
below. The customer or user of the pro7
model should ensure that it is used in s
uch an environment:
–
Floors should be wood, concrete or cera
mic tile. If the floor is covered with synth
etic material, the relativehumidity in the r
oom should be at least 30%.
–
Power quality should be that of a typical
domestic, commercial or hospital envir
onment as appropriate.
–
The pro7 model should not be used
during power interruptions.
–
Power frequency magnetic fields should
be at levels characteristic of a typical lo
cation in a typical commercial or hospit
al environment.
The pro7 model is intended for use in an
electronic environment in whichradiated
radio-frequency (RF) disturbances
are controlled.
The customer or user of the pro7 model c
an help prevent electromagnetic interfer
ence by maintaining a minimum distanc
e between portable and mobile RF com
munications equipment (transmitters) an
d the pro7 model as recommended in th
is user manual, according to the maximu
m output power of the communications
equipment:
12 of 22
13 of 22
The adequate separation distance
to provide base immunity to RF d
isturbances is 1.0m.
•
USB Port - USB port supplies 5Volt DC c
urrent. This port is only used for soft- wa
re updates and uploading personal pict
ures to user profiles. The operator must
take care to not touch the USB port and
a patientsimultaneously.
•
LAN port - the pro7 has included a L
AN port on the lower back side of th
e machine. This LAN port is used to c
onnect a LAN cable to access the
internet.The operator musttake care to
not touch the LAN port and a patient
simultaneously.
•
Phone jack adapter- On the Control
Panel of the pro7, there is a phone j
ack adapter for sound playback. The
operator must take care to not touch
the Phone jack adapter and a patient
simultaneously.
Retain this user manual for your future
reference.
Summary of Contents for pro7
Page 1: ...pro7 Model...
