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23

eNgLIsh

Recommended separation distance between portable and mobile radio-communication devices and the monitor
The 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 interfer-

ence 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

Separation distance from the frequency transmitter (m)

150KHz a 80MHz

3,5

 V

1

√P

d

=

80MHz a 800MHz

12

 E

1

√P

d=

800MHz a 2,5GHz 

 

23

 E

1

√P

d=

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

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.

SYMBOLS

Caution: read instructions (war-

nings) carefully

Follow instructions for use

Keep in a cool, dry place

Keep away from sunlight

Manufacturer

Date of manufacture

Product code

Lot number

Medical Device complies with 

Directive 93/42/EEC

Type B applied part

WEEE disposal

Class II applied

Serial number

Temperature limit

Fuse

~

Alternating current

ON / OFF

Atmospheric pressure limit

Summary of Contents for TOBI HOSPITAL

Page 1: ...ASPIRATEUR TOBI HOSPITAL CHIRURGISCHER ABSAUGER TOBI HOSPITAL ASPIRADOR QUIR RGICO TOBI HOSPITAL 28202 28232 28233 28234 M28202 M Rev 7 01 21 Gima S p A Via Marconi 1 20060 Gessate MI Italy gima gima...

Page 2: ...unstable surfaces which may cause it to acci dentally fall and lead to a malfunction and or breakage Should there be signs of damage to the plastic parts which may expose inner parts of the energised...

Page 3: ...ive and its normatives Under certain failure conditions the temperature of the casing may become hot and there may be a risk of burns if you touch those parts In any case the temperatures do not excee...

Page 4: ...anteed up to 30 cycles of cleaning and sterilization Beyond this limit the physical chemical characteristics of the plastic material may show signs of decay Therefore we recommend that you to change i...

Page 5: ...nd cooling at environment temperature of the parts make sure that these are not damaged The aspiration tubes can be sterilized on autoclave using a sterilization cycle at 121 C 1 bar relative pressure...

Page 6: ...After sales Assistance Service If the overfill security system it s activated don t proceede with the liquid aspiration If the overfill security system doesn t work there are two cases 1 case If the...

Page 7: ...e jar is reached there is the activation of the security float the float close the aspiration connector on the jar to avoid liquid penetration inside the device The device must be used on a plan of ho...

Page 8: ...cover bends towards the inside of the glass the system is not leaking Start the aspiration and periodically check the filling level of the container The overflow valve will cause the interruption of a...

Page 9: ...it s used in such an environment Immunity Test Level indicated by the EN 60601 1 2 Compliance Level Electromagnetic environments guidance Electrostatic discharge ESD EN 61000 4 2 8kV on contact 15kV i...

Page 10: ...fixed RF transmitters as determined by an electromagnetic site study of the site should be less that the com pliance level in each frequency range Interference may occur in the vicinity of equipment...

Page 11: ...3 10 3 8 3 8 7 3 100 12 12 23 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 t...

Page 12: ...specifications may change without notice Disposal The product must not be disposed of along with other domestic waste The users must dis pose of this equipment by bringing it to a specific recycling p...

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