reflection from buildings, objects and people.
a) The field intensity for fixed transmitters such as the base stations for radiotelephones (mobile and cordless) and terrestrial mobile radio,
amateur radio devices, radio AM and FM transmitters and TV transmitters can not be theoretically and accurately foreseen.
To establish an electro-magnetic environment generated by fixed RF transmitters, an electro-magnetic study of the site should be considered. If
the field intensity measured in the place where the device will be used surpasses the above mentioned applicable level of conformity, the normal
functioning of the device should be monitored. If abnormal performance arises, additional measures such as changing the device's direction or
positioning may be necessary.
b) The field intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V/m.
Recommended separation distance between portable and mobile radio-communication devices and the monitor
The TOBI HOSPITAL surgical aspirator is intended to operate in an electro-magnetic environment where RF irradiated interferences are under
control. The client or operator of the TOBI HOSPITAL device can help prevent electro-magnetic interference by keeping a minimum distance
between the portable and mobile RF communication devices (transmitters) and the TOBI HOSPITAL device, as recommended below, in relation to
the radio-communication maximum output power.
Maximum nominal
output power of the
Transmitter W
0,01
0,1
1
10
100
For transmitters with a maximum nominal output power not shown above, the recommended separation distance in metres (m) can be calculated
using the equation applicable to the transmitter frequency, where P is the maximum nominal output power of the transmitter in Watt (W)
depending on the transmitter's manufacturer.
Note 1: At 80 MHz and 800 MHz the interval with the highest frequency is applied
Note 2: These guide lines may not be applicable in all situations. The electro-magnetic propagation is influenced by the absorption and by the
reflection from buildings, objects and people.
This section contains information regarding the conformity of the compliance with the IEC 60601-1-2 Standard.
The TOBI HOSPITAL surgical aspirator is an electro-medical device that requires particular precautions regarding electro-magnetic compatibility and
which must be installed and commissioned according to the electro-magnetic compatibility information supplied.
Mobile and portable RF communication appliances (mobile phones, transceivers, etc..) can affect the medical system.
The use of accessories, transducers and cables different to those specified, with the exception of transducers and cables sold by the appliance and
system manufacturer as spare parts, can lead to an increase in emissions or in a decrease of the immunity of the device or system.
Replacing the antibacterial filter:
The filter is made of hydrophobic material that stops the passage of liquids into the same filter.
If you suspect the filter may have been contaminated and/or got wet or discoloured, always remove and replace the filter.
If the equipment is to be used on patients with unknown pathological conditions or should you evaluate the possibility of indirect contamination,
remove and replace the filter after each utilization. The filter is not designed for decontamination, disassembly and/or sterilization. If you suspect
the filter may have been contaminated and/or got wet or discoloured, always remove and replace the filter. If the equipment is to be used on patients
whose pathologies are known and not implying any indirect contamination risks, we recommend to remove and replace the filter at the end of each
work shift or else every month, even if the equipment has not been used. 4000cc complete tank versions are available on request.
Versions fitted with FLOVAC® 2000ml or 3000ml disposable collection systems (including a re-usable rigid polycarbonate container and a
disposable Liner) are also available on request.
WARNING: Suction tubes for insertion in the human body purchased separately from the machine should comply with ISO 10993-1 standards
on material biocompatibility
.
Separation distance from the frequency transmitter (m)
150 kHz to 80 MHz
80 MHz to 800 MHz
P
d = [3.5 / V
]
d = [12/E
1
0,12
0,38
1,2
3,8
12
ACCESSORIES SUPPLIED
N°2 COMPLETE ASPIRATION JAR 2000cc
ANTIBACTERIAL AND HYDROFOBIC FILTER
FOOTSWITCH CONTROL (for versions equipped with footswitch control)
P
]
1
0,12
0,38
1,2
3,8
12
DESCRIPTION
CONICAL FITTING
TUBES SET 8 mm x 14 mm
13
800 MHz to 2.5 GHz
P
d = [23/E
]
1
0,23
0,73
2,3
7,3
23