Gima TOBI HOSPITAL"" SUCTION User guide

ASPIRATORE CHIRURGICO TOBI HOSPITAL
TOBI HOSPITAL SUCTION ASPIRATOR
ASPIRATEUR TOBI HOSPITAL
CHIRURGISCHER ABSAUGER TOBI HOSPITAL
ASPIRADOR QUIRÚRGICO TOBI HOSPITAL

M28202-M-Rev.7-01.21

28202 - 28232 - 28233 - 28234

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Made in Italy

0476

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TOBI HOSPITAL is a surgical aspirator power-fed at 230V ~ / 50Hz, to be used for suctioning body liquids
(such as mucus, phlegm and blood) provided with 4 antistatic wheels, two of which with braking device,
and a pulling handle.
This equipment is designed for easy transport and continuous utilization.
Thanks to these characteristics and to its functions, this device is particularly suitable for utilization in
hospital wards and operation theatres both for suctioning body liquids and for gynaecological and der­matological (liposuction) applications.
It’s provided with a plastic body, with thermal and electrical isolation in compliance with European safety

standards, two complete suction tanks in polycarbonate suitable for sterilization, and a oat valve, besi­des being tted with a suction regulator and a vacuum gauge on the front panel. Available under request

with differents versions for applications and use (version with remote control, version with 4 litre jars,

version with ow direction regulator).

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• Read instruction manual carefully before use

• Only highly qualied staff use reserved

• The instrument must not be disassembled. for a technical service always contact GIMA

IMPORTANT SAFETY RULES:

1. Check the condition of the unit before each use. The surface of the unit should carefully inspected for

visual damage. Check the mains cable and do not connect to power if damage is apparent;

2. Before connecting the appliance always check that the electric data indicated on the data label and

the type of plug used, correspond to those of the mains electricity to witch it’s to be connected;

3. Respect the safety regulations indicated for electrical appliances and particularly:

• Use original components and accessories provided by the manufacturer to guarantee the highest

efciency and safety of the device;

• The device can be used only with the bacteriological lter;

• Never immerge the appliance into water;

• Position the device on stable and at surfaces in a way that the air inlets on the back aren’t obstructed;

• To avoid incidents, do not place the aspirator on 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 device, do not connect the plug to the
electrical socket. Do not attempt to make the device work before it has been thoroughly checked by

qualied personnel and/or the GIMA technical service department.

• Don’t use in the presence of inammable substances such as anaesthetic, oxygen or nitrous oxide;

• Don’t touch the device with wet hands and always prevent the appliance coming into contact with

liquids;

• Don’t leave the appliance connected to the power supply socket when not in use;

• Don’t pull the power supply cable to disconnect the plug remove the plug from the mains socket

correctly;

• Store and use the device in places protected against the weather and far from any sources of heat.

After each use, it is recommended to store the device in its own box away from dust and sunlight.

• In general, it is inadvisable to use single or multiple adapters and/or extensions. Should their use be
necessary, you must use ones that are in compliance with safety regulations, however, taking care not
to exceed the maximum power supply tolerated, which is indicated on the adapters and extensions.

4. For repairs, exclusively contact technical service and request the use of original spare parts. Failure

to comply with the above can jeopardise the safety of the device;

5. Use only for the purpose intended. Don’t use for anything other than the use dened by the manu-
facturer. The manufacturer will not be responsible for damage due to improper use or connection to
an electrical system not complying with current regulation.

6. Instrument and accessory discharging must be done according to current regulations in the country
of use.

7. WARNING: Do not change this equipment without the permission of the manufacturer. None of elec­tric or mechanical parts have been designed to be repaired by customers or end-users. Don’t open
the device, do not mishandle the electric / mechanical parts. Always contact technical assistance

8. Using the device in environmental conditions different than those indicated in this manual may harm

seriously the safety and the technical characteristics of the same;

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9. The medical device is in contact with the patient by means of a disposable probe (not supplied with

the device). If this device must be used with a specic suction probe, the end user is responsible for
making sure it complies with the ISO 10993-1 rule;

10. The product and its parts are biocompatible in accordance with the requirements of regulation EN

60601-1;

11. Operation of the device is very simple and therefore no further explanations are required other than
those indicated in the following user manual.

12. The medical device requires special precautions regarding electromagnetic compatibility and must be
installed and used in accordance with the information provided with the accompanying documents:
the TOBI HOSPITAL device must be installed and used away from mobile.



The Manufacturer cannot be held liable for accidental or indirect damages should the device be

modied, repaired without authorization or should any of its component be damaged due to
accident or misuse. Any minimal modication / repair on the device voids the warranty and does

not guarantee the compliance with the technical requirements provided by the MDD 93/42/EEC
Directive 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 exceed the limit of
105°C (rif. Interpretation Sheet IEC 60601-1 - ISH3 May 2013).

CONTRAINDICATIONS:

• Before using the TOBI HOSPITAL, consult the instructions for use: failure to read all the instructions in

this manual can be harmful for the patient.

• The device cannot be used to drain chest uids;

• The device must not be used for suction of explosive, corrosive or easily ammable liquids.

• TOBI HOSPITAL is not suitable for MRI. Do not introduce the device in MRI environments.

TECHNICAL CHARACTERISTICS:

TYPOLOGY (MDD 93/42/EEC) Class IIa Medical Decice

MODEL

UNI EN ISO 10079-1 HIGH VACUUM / HIGH FLOW

POWER FEEDING 230V ~ / 50Hz

POWER CONSUMPTION 385 VA

FUSE F 1 x 4A L 250V

MAXIMUM SUCTION PRESSURE (without jar) -90kPa / -0.90 Bar / -675mmHg

MAXIMUM SUCTION FLOW (without jar) 90 l/min

WEIGHT 20 Kg

SIZE 650 x 550 (h) x 450mm

DUTY CYCLE Non – Stop Operated

SICILICONE TUBE SIZE Ø 8x14 mm

ACCURANCY OF VACUUM INDICATOR ± 5%

WORKING CONDITION

CONSERVATION CONDITION AND TRASPORT

TOBIHOSPITAL

Room temperature: 5 ÷ 35°C
Room humidity percentage: 30 ÷ 75% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Altitude: 0 ÷ 2000m s.l.m.

Room temperature: - 40°C ÷ 70°C
Room humidity percentage: 10 ÷ 100% RH
Atmospheric pressure: 500 ÷ 1060 hPa

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CLEANING THE MAIN UNIT:

To clean the device external parts always use a cotton cloth dampened with detergent. Don’t use abra­sive or solvent detergents.

PARTICULAR CARE SHOULD BE TAKEN TO ENSURE THAT THE INTERNAL PARTS OF THE

EQUIPMENT DO NOT GET IN TOUCH WITH LIQUIDS.
NEVER CLEAN THE EQUIPMENT WITH WATER.

During all clearing operations use protection gloves and apron (if need be, also wear a face mask and
glasses) to avoid getting in contact with contaminating substances (after each utilization cycle of the
machine).

ACCESSORIES SUPPLIED

• N°2 COMPLETE ASPIRATION JAR 2000ml

• CONICAL FITTING

• TUBES SET 8 mm x 14 mm

• ANTIBACTERIAL FILTER

• FOOTSWITCH CONTROL (for versions equipped with footswitch control)

• POWER CORD (H05VV-F - 2x0.75mm2 - 2mt)

Replacing the antibacterial filter:

The lter is made of hydrophobic material that stops the passage of liquids into the same lter.
If you suspect the lter may have been contaminated and/or got wet or discoloured, always remove and
replace the lter.

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 lter

is not designed for decontamination, disassembly and/or sterilization. If you suspect the lter may have
been contaminated and/or got wet or discoloured, always remove and replace the lter. 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 lter at the end of each work shift or else every month,

even if the equipment has not been used. 4000ml complete tank versions are available on request.
Aspiration jar: the mechanical resistance of the component is guaranteed 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 it.

Silicone tubes: the number of cycles of sterilization and/or cleaning is strictly linked to the employment
of the said tube.

Therefore, after each cleaning cycle, it is up to the nal user to verify whether the tube is suitable for

reuse. The component must be replaced if there are visible signs of decay of the material constituting
the said component.

Conical fitting: the number of cycles of sterilization and the number of cleaning cycles is strictly linked

to the employment of the said component. Therefore, after each cleaning cycle, it is up to the nal user
to verify whether the tting is suitable for reuse.

The component must be replaced if there are visible signs of decay in the material constituting the said
component.

Service life of the device: more than 10000-12000 hours of operation (or 3 years) in accordance with the
standard conditions of testing and operation. Shelf life: maximum 5 years from the date of manufacture.

WARNING: Suction tubes for insertion in the human body purchased separately from the machine
should comply with ISO 10993-1 standards on material biocompatibility. The medical device is provided

without a specic suction probe. If this device must be used with a specic suction probe, the end user is

responsible for making sure it complies with the EN 10079-1 regulation.

CLEANING ACCESSORIES

Before using the device, the manufacturer advises you to clean and/or sterilize the accessories.
Washing and/or cleaning the autoclavable jar as to be carried out as follows:

• Wear protection gloves and apron (glasses and face mask if necessary) to avoid contact with

contaminating substances;

• Disconnect the tank from the device and remove the said container from the support of the device.

• Separate all the parts of the cover (overow device, washer).

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• Disconnect all tubes from the jar and the protection lter

• Wash each part of the container from secretions under cold running water and then clean every

single part in hot water (temperature not exceeding 60°C)

• Once again, carefully wash each single part using, if necessary, a non-abrasive brush to remove

any deposits. Rinse with hot running water and dry all parts with a soft cloth (non-abrasive). It is
possible to wash with commercial disinfectants by carefully following the instructions and dilution
values supplied by the manufacturer. After cleaning, leave the parts to dry in an open, clean envi­ronment.

• Dispose of the aspiration catheter according to that provided by local laws and regulations.

The silicone aspiration tubes and the conical tting may be carefully washed in hot water (temperature

must not exceed 60°C). After cleaning, leave the parts to dry in an open, clean environment.
When cleaning is complete, reassemble the container for liquid aspirations according to the following

procedure:

• Place the overow valve into its seat in the cover (under VACUUM connector)

• Insert oating valve keeping the o-ring towards the opening of the cage

• Place the o-ring into its seat around the cover

• After completing assembling operations always make sue that cover seals perfectly to avoid vacu-

um leackages or liquid exit
After disposing of disposable parts and disassembling the jar wash in running cold water and rinse
thouroughly. Then soak in warm water (temperature shall not exceed 60°C). Wash thouroughly and if
necessary use a non-abrasive brush to remove incrustations. Rinse in running warm water and dry all
parts with a soft cloth (non-abrasive). The jar and the cover can be autoclaved by placing the parts into
the autoclave and running one sterilization stem cycle at 121°C (1 bar relative pressure – 15 min) ma­king sure that the jar is positioned upsidedown. Mechanical resistance of the jar is guaranteed up to 30
cycles of sterilization and cleaning at the indicated conditions (EN ISO 10079-1). Beyond this limit the
physical-mechanical characteristics of the plastic may decrease and replacement of the part is therefore
recommended. After sterilization and 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 – 15 min). The conical connector can be sterilized on autoclave using
a sterilization cycle at 121°C (1 bar relative pressure – 15 min).

DONOTWASH,STERILIZEORPUTINAUTOCLAVETHEANTIBACTERIALFILTER

Instruction for disposal Liner Flovac®:
If the device is equipped with disposable collection systems FLOVAC ® carry out the disposal of the bag
as follows: turn off the Vacuum and remove all the tubes connected to the Liner, giving particular atten­tion to avoid accidental contamination. Fit the appropriate plugs to the “PATIENT” and “TANDEM” ports,

pressing the home rmly, taking care to avoid accidental contamination. Turn the buttery connector to

OFF. Remove the liner bag from the rigid container and transfer it to the waste disposal area, ensuring
that all the openings are sealed, keeping in mind the product is potentially infectious. This product must
be disposed of in accordance with the current hospital regulations.

PERIODICAL MAINETANCE CHECKS

The TOBI HOSPITAL suction equipment does not need maintenance or lubrication. It is, however, ne­cessary to inspect the unit before each use. With regard to training, given the information contained in
the user manual and since it is easy to understand the said device, it doesn’t appear to be necessary.
The device must be checked before each use in order to detect malfunctions and / or damage caused
by transport and / or storage.
Always check the integrity of the footswitch power cord. Connect cable to electrical network and turn

switch on. Close the aspiration outlet with your nger and with suction regulator in maximum vacuum

position check that the vacuum indicators reaches -90 kPa (-0.90 bar) maximum. Rotate the knob from
right to left and check the aspiration regulating control. The vacuum indicator should go down -40 kPa
(-0.40 bar). Verify that loud noises are not present, these can indicate wrong functioning. A protection
fuses (F 1 x 1.6 A L 250V) reachable from exterior and situated in the plug protects the instrument. For
fuses replacing, always the type and the range. Before changing the fuse, disconnect the plug from the

power supply socket. Internally, the device (only for devices tted with a circuit board) is protected by a

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fuse (T 50mA L 250V) that cannot be reached from the outside, so please contact a technician authori-
sed by the manufacturer for its replacement.

Faulttype Cause Solution

1. The suction unit doesn’t
work

2. No aspiration Jar Cap badly screwed down

3. No aspiration Lid seal not in its seat

4. The Vacuum power on the
patient side is either very low
or absent

5. The oat doesn’t close

6. The oat doesn’t close

7. Low suction Foam inside the jar Fill the jar to 1/3 full of ordinary water

Faults 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8

Cable is damaged
External power source failure

a) Vacuum regulator set to minimum
b) Protection lter blocked or dama-

ged
c) Connection tubes blocked, kinked

or disconnected
d) Shut-off valve blocked or dama-

ged
e) Pump motor damaged

If the cap has been washed, ensure

that the oat is not partially detached

The oat it’s covered by dirty mate-

rial

None of the remedies has achieved
the desired results

Replace the cable
Check the external power source

Unscrewed the cap, then rescrew it
correctly

Unscrew the cap and insert the seal
properly in its seat

a) Turn the vacuum regulator clockwise
and check the value of the vacuum on the
gauge

b) Replace the lter

c) Replace or reconnect the tubes, check
the jar connections
d) Empty the jar, or disconnect the tube
from the jar and unblock the shut-off val­ve. The unit twill only work in the upright
position
e) Refer to authorised service personnel

Insert the oat into it’s place

Unscrewed the cap, leave the and put in
on autoclave

Contact the seller or GIMA After-sales
Assistance Service

If the overll security system it’s activated, don’t proceede with the liquid aspiration.
If the overll security system doesn’t work there are two cases:
1° case – If the overll security system doesn’t work the aspiration will be stopped by the bacteriological
lter who avoid the liquid penetration inside the device.

2° case – If both the security system doesn’t work, there is the possibility that liquid comes inside the
device, in this case return the device to GIMA technical service.

GIMA Srl will provide upon request electric diagrams, components list, descriptions, setting instructions
and any other information that can help the technical assistance staff for product repair.

BEFORE EVERYCHECKINGOPERATION,INCASE OFANOMALIESORBADFUNCTIONING,
PLEASECONTACTGIMATECHNICALSERVICE.
GIMADOESNOTGIVEGUARANTEEIFINSTRUMENT,AFTERTHETECHNICALSERVICECHECKING,
APPEARSTOBETAMPERED.

INSTRUCTION FOR USE

• The working position must be such as to allow one to reach the control panel and to have a good view

of the empty indicator, the jar and the antibacterial lter.

• If the device is to be transported from one place to another, to prevent the liquid collection jar from

falling and consequently the liquid from spilling, removing the jar from the device is recommended.

WARNING: For proper use, place the aspirator on a at, stable surface in order to have the full volume
of use of the jar and better efciency of the overow device. The vacuum jar, during use, must be used
in vertical mode, to prevent the action of the backow valve. If this protection is triggered, turn the device

off and disconnect the pipe connected to the vacuum jar (indicated with the word VACUUM) on its cover.

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

WARNING: For proper use, place the aspirator on a at, stable surface in order to have the full

volume of use of the jar and better efciency of the overow device. The vacuum jar, during use, must
be used in vertical mode, to prevent the action of the backow valve. If this protection is triggered, turn

the device off and disconnect the pipe connected to the vacuum jar (indicated with the word VACUUM)
on its cover.

WARNING: Ensure that the IN marker on the lter is on the side facing the collection jar lid and tted

into the “VACUUM”.
A wrong connection causes immediate destruction in case of contact with sucked liquids.

FLOW DIRECTION

Suction Pump Inlet Jar Air Tube

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• Connect the short silicon tube, with lter

antibacterial, to the suction connector . The
other tube, with one end connected to the

lter must be connected with the other end
to jar's lid connector where has been xed
the red oat. When the 90% of the volume

of the jar is reached there is the activation

of the security oat (the oat close the

aspiration connector on the jar) to avoid
liquid penetration inside the device. The
device must be used on a plan of horizontal
operation.

• Connect the long silicon tube to the other

jar's lid connector

• Connect the other end of the long silicon

tube to the probe plastic connector then
connect the suction probe to it.

• Connect the power cord to the device then

connect the plug to the electrical mains
supply.

• Push switch on position I to start suction

• Once nished push switch on 0 position and unplug.

• Unscrew the jar's lid and ll the jar 1/3 full or ordinary water (this for an easy cleaning operations and

an rapid reaching of the functionally vacuum) then rescrew the lid on the jar correctly.

• To extract the accessories and start with cleaning.

WARNING: The power supply cable plug is the element of separation from the electrical mains system:
even if the units equipped with a special on / off switch button, the power supply plug must be kept ac­cessible once the device is in use so as to allow a further method of disconnection from the mains supply
system.

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Footswitch control device:

The equipment, on request, is provided with a footswich control device. It allows the continuous use of
the surgical aspirator. In this case, the plug of the footswitch device shall be inserted into the appropriate
socket outlet placed on the back side of the equipment.

Near the ON/OFF Switch, there is a commutator that operates the device directly using the mains or by
using the footswitch control.
When the switch is turned on (green light) and the commutator is in position I, the device works directly
using the mains.
When the switch is turned on (green light) and the commutator is in position II, the device works via
remote control (footswitch control).
When the switch is turned on (green light) and the commutator is in position 0, the device is powered but
not in operation.

Using FLOVAC® disposable collection system:

Before connecting the disposable collection system, remove the blu ring tted on the tank holder for a

more comfortable insertion of the same container.

• After opening the package, fully stretch the bag and then atten it concentrically to eliminate as much

air as possible.

• Insert the bag and apply the cover to an appropriately sized reusable rigid container by pressing rmly

around the entire perimeter. Make sure that the system is completely sealed.

• close the connector marked as “TANDEM” with the lid provided.

• Connect the power source of the vacuum to the VACUUM port equipped with specic reusable conical

tting with "male" connection.

• Connect the patient tube to the PATIENT port of the cover

• Before use, check all closures and make sure there are no leaks, starting the aspiration source. If the

bag expands to fully adhere to the walls of the rigid container and the cover bends towards the inside
of the glass, the system is not leaking.

• Start the aspiration and periodically check the lling level of the container. The overow valve will cause

the interruption of aspiration if the aspirated uids have reached the maximum lling level of the device.

• When the oat valve intervenes signalling the device is too full, the suction source must be disconnected

within no more than 5 minutes.

Warning: The accidental inversion of connections may cause contamination for the operator and/
or for the vacuum generation equipment.

NEVERUSETHEDEVICEWITHOUTJARAND/ORPROTECTIONFILTER.

RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES

This section contains information regarding the conformity of the compliance with the EN 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. Portable and mobile radio communication devices
(mobile phones, transceivers, etc.) may interfere with the medical device and should not be used in close
proximity with, adjacent to or on top of the medical device.
If such use is necessary and unavoidable, special precautions should be taken so that the electro-medical

device functions properly in its intended operating conguration (for example, constantly and visually

checking for the absence of anomalies or malfunctions).

The use of accessories, transducers and cables different to those specied, 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. The following tables
supply information regarding the EMC (Electromagnetic Compatibility) characteristics of the electro­medical device.

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Guidanceandmanufacturer’sdeclaration–ElectromagneticEmissions

The surgical aspirator TOBI HOSPITAL is intended for use in the electromagnetic environment specied below. The

customers or the user of the surgical aspirator TOBI HOSPITAL should assure that it’s used in such an environment.

EmissionsTest Compliance Electromagneticenvironment-guidance

Irradiated / Conducted
emissions CISPR11

Group 1 The surgical aspirator TOBI HOSPITAL only used RF energy only

for its internal functioning. Therefore its RF emissions are very
low and are not cause interference in proximity of any Electronic
appliances.

Irradiated / Conducted
emissions CISPR11

Harmonic emissions
EN 61000-3-2

Voltage uctuations /

Class [B] The surgical aspirator TOBI HOSPITAL can be used in all en-

vironments, including domestic and those connected directly to

Class [A]

the public mains distribution that supplies power to environments
used for domestic scopes.

Complies

icker emissions EN 61000-

3-3

Guidanceandmanufacturer’sdeclaration–ImmunityEmissions

The surgical aspirator TOBI HOSPITAL is intended for use in the electromagnetic environment specied below. The

customers or the user of the surgical aspirator TOBI HOSPITAL should assure that it’s used in such an environment.

ImmunityTest Levelindicatedbythe

EN60601-1-2

Electrostatic
discharge
(ESD) EN 61000-

± 8kV on contact
± 15kV in air

4-2

Electrical fast
transient / burst
EN 61000-4-4

± 2kV power supply
lines
± 1kV for input / output

ComplianceLevel Electromagneticenvironments-

guidance

The device doesn’t
change its state

Floors should be wood, conceret or

ceramic tile. If oors are covered with

synthetic material, the relative humidity
should be at least 30%.

The device doesn’t
change its state

Mains power quality should be that of
a typical commercial environment or
hospital.

lines

Surge
EN 61000-4-5

Loss of voltage,
brief voltage
interruptions and
variations EN
61000-4-11

Magnetic eld

(50/60 Hz)
EN 61000-4-8

± 0.5kV
+/-1kV differential

mode

T (>95% dip UT )

<5% U
for 0,5 cycle

T (> 60% dip UT)

40 % U
for 5 cycle

T (> 30% dip

70 % U
UT) for 25 cycle

T (>95% dip UT)

<5 % U
for 5 sec

30A/m

The device doesn’t
change its state

Mains power quality should be that of
a typical commercial environment or
hospital.

- - Mains power quality should be that of a
typical commercial environment or hos­pital If the user of the surgical aspirator
TOBI HOSPITAL request that the appli­ance operates continuosly, the use of a
continuity unit is recommended.

The device doesn’t
change its state

The power frequency magnetic eld

should be measured in the intended
installation location to assure that it’s

sufciently low.

Note UT is the value of the power supply voltage.

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Guidanceandmanufacturer’sdeclaration–ImmunityEmissions

The surgical aspirator TOBI HOSPITAL is intended for use in the electromagnetic environment specied below. The

customers or the user of the surgical aspirator TOBI HOSPITAL should assure that it’s used in such an environment.

ImmunityTest Levelindicatedby

Conducted
Immunity
EN 61000-4-6

Radiated
Immunity
EN 61000-4-3

theEN60601-1-2

3Vrms 150kHz to
80Mhz (for non life­supporting devices)

3V/m 80MHz to

2.5GHz (for non life­supporting devices)

Livellodi
conformità

V1 = 3 V rms

E1 = 3 V / m

Electromagneticenvironments-guidance

The portable and mobile RF communication devices,
including cables, must not be used closer to the
TOBI HOSPITAL device, than the separation dis­tance calculated by the equation applicable to the
transmitter frequency.

Recommendedseparationdistance

3,5

√P

d=

1

V

12

from 80MHz to 800MHz

√P

d=

1

E

23

d=

1

E

Where P is the maximum output power rating of the
transmitter in Watt (W) according to the transmitter
manufacturer and is the recommended separation

distance in metres (m). Field strengths from xed RF

transmitters, as determined by an electromagnetic
site study of the site, should be less that the com­pliance level in each frequency range. Interference
may occur in the vicinity of equipment
marked with the following symbol:

from 800MHz to 2,5GHz

√P

22

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 inuenced by

the absorption and by reection from buildings, objects and people.

a) The eld intensity for xed 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 theor-

etically and accurately foreseen. To establish an electro-magnetic environment generated by xed RF transmitters,
an electro-magnetic study of the site should be considered. If the eld 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 eld intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V/m.

23

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 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 0,12 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 inuenced by

the absorption and by the reection from buildings, objects and people.

Separationdistancefromthefrequencytransmitter(m)

150KHz a 80MHz

3,5

√P

d=

1

V

80MHz a 800MHz

d=

12

1

E

eNgLIsh

√P

800MHz a 2,5GHz

23

√P

d=

1

E

SYMBOLS

Caution: read instructions (war­nings) 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

eNgLIsh

24

0/I/II

IPX1

The technical specications 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 specic recycling point for electric and
electronic equipment.

Remote Control

Covering Protection rate Humidity limit

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.

Hz

Mains frequency