Gima EOLO User manual

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EOLO is an electrical fed compressor with aerosol therapy atomiser.
The instrument is designed for easy transport and handing and is recommended for atomising antibiotics and bronchodilator
drugs. The high thermal insulated plastic body complies with European Safety Rules. The medical device is designed for continuous
use
GENERAL WARNING
READ INSTRUCTION MANUAL CAREFULLY BEFORE USE
DRUG ADMINISTRATION MUST BE UNDER MEDICAL CONTROL
THE INSTRUMENT MUST NOT BE DISASSEMBLED. FOR A TECHNICAL SERVICE ALWAYS CONTACT GIMA
IMPORTANT SAFETY RULES
1. On opening the packaging, check the integrity of the appliance, paying particular attention to the presence of damage to the
plastic parts, which may make access possible to internal live parts and also to breakage and / or peeling of the power supply
cable. In these cases don’t connect the plug to the electric socket. Carry out these controls before each use;
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. Never leave the appliance inserted if not necessary disconnect the plug from the mains power supply when it is not being
used;
4. Respect the safety regulations indicated for electrical appliances and particularly:
Only use original accessories and components provided by the manufacturer GIMA to guarantee the highest efficiency and
safety of the device;
Never immerge the appliance into water;
Position the appliance on flat stable surfaces;
Position the device in a way that the air inlets on the back aren’t obstructed;
Never use the device in environments which have anaesthetic mixtures inflammable with air, oxygen or nitric oxide;
Don’t touch the device with wet hands and always prevent the appliance coming into contact with liquids;
The use of this device by children and / or incompetent person always requires the careful surveillance of an adult in
possession of their full mental faculties;
The medical device, and most of all the nebulae, must be kept out of children’s reach as it contains small parts hat could be
swallowed;
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.
5. For repairs, exclusively contact GIMA technical service and request the use of original spare parts.
Failure to comply with the above can jeopardise the safety of the device;
6. This medical device must be destined exclusively for the use for witch it has been designed ad described in this
manual. It must therefore be used as an aerosol therapy system. Any different use must be considered incorrect and
therefore dangerous; the manufacturer cannot be considered liable for damage caused by improper, incorrect and / or
unreasonable use or if the appliance is used in electrical plants that are not in compliance with the regulations in force;
7. 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 Eolo device must be installed and used
away from mobile and portable RF communication devices (mobile phones, transceivers, etc.) that may interference with the
said device.
8. Store the accessories out of reach of children. Children and people with learning difficulties must only use the medical device
under the strict supervision of an adult with full mental faculties. Keep the ampoule out of reach of children under 36 months
as it contains small parts that may be swallowed accidentally. Never leave the device unattended in places accessible to
minors and / or the disabled.
9. WARNINIG: 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 GIMA technical assistance.
10. Do not leave the device unattended in places accessible to children and / or persons not in full possession of their mental
faculties as there is a risk of strangulation with the air tube;
11. The medical device may come into contatct with the patient via the nubuliser / masks / mouthpiece and / or nosepiece,
components compliant with the requirements of regulation ISO 10993-1: therefore, no allergic reaction and skin irritation
may occur.
12. The product and its parts are biocompatible in accordance with the requirements of regulation EN 60601-1.
13. Operation of the device is very simple and therefore no further explanations are required other than those indicated in the
following user manual.

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14. 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;
15. The materials used to contain the drugs are made with highly stable thermoplastic polymers that are resistant against
chemicals. Such materials were tested with commonly used drugs (Salbutamol, Beclametasone dipropionate, Acetylcysteine,
Budesonide, Ambroxol) and no interaction phenomenon was observed. Interactions cannot however be excluded given the
variety and the continuous evolution of the drugs that are used. Remember to:
To consume the drugs as quickly as possible after opening its package;
To avoid keeping the drug in the tray-like container for too long and to clean it immediately after every application;
If the tray-like container presents any abnormal situation (such as softening or cracks), do not introduce any solution and
do not proceed with the inhalation. Contact the technical service and describe the methods and type of drugs used.
16. Remember to:
Only use this device with medicines prescribed by your doctor;
Carry out the treatment only using the accessory indicated by the doctor according to the pathology.
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 (ref.
Interpretation Sheet IEC 60601-1).
TECHNICAL CHARACTERISTICS
Model
EOLO NEBULIZER
Typology (MDD 93/42/EEC)
Class IIa Medical device
Power Feeding
230V ~ / 50 Hz
Power Consumption
170 VA
Fuse
F 1 x 1.6A L 250V
Max Pressure
250 kPa (2.5 Bar)
Max Air Flow
14 l/min
Operating Pressure
110 kPa (1.1 Bar)
Operating Air Flow
5.0 l/min a 110 kPa
Neb-Rate (with 4ml of 0.9% NaCl solution)
0.40 ml/min with 4ml of 0.9% NaCl solution
MMAD
2.44 µm
GSD
2.87
Weight
1.65 Kg
Size
148 x 223 (h) x 124 (h)
Noise Level (measured as specifications of EN 13544-1)
Approx. 55dB (A)
Duty Cycle (to 40°C and 110% operating voltage)
Non-Stop Operated
Min Capacity Nebulizer
2ml
Max Capacity Nebulizer
6ml
Working Condition
Room temperature: 5 ÷ 40 °C
Room humidity percentage: 10 ÷93 % RH
Atmospheric pressure: 700 ÷ 1060 hPa
Conservation condition and Transport
Room temperature: - 25 ÷70 °C
Room humidity percentage: 0 ÷ 93% RH
Atmospheric pressure: 500 ÷ 1060 hPa
The manufactured cannot be held liable for accidental or indirect damages should the device be
modified, repaired without authorization or should any of its component be damaged due to accident
or misuse. Any minimal modification / repair on the device voids the warranty and does not guarantee
the compliance with the technical requirements provided by the MDD 93/42/EEC (and subsequent
changes) and its normatives.
IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC
DIRECTIVE 2012/19/UE-WEEE:
The symbol on the device indicates the separated collection of electric and electronic equipment. At the end of
life of the device, don’t dispose it as mixed solid municipal waste, but dispose it referring to a specific
collection centre located in your area or returning it to the distributor, when buying a new device of the
sample type to be used with the same functions. This procedure of separated collection of electric and
electronic devices is carried out forecasting a European environmental policy aiming at safeguarding,
protecting and improving environment quality, as well as avoiding potential effects on human health due to
the presence of hazardous substances in such equipment or to an improper use of the same or of parts of the
same Caution: The wrong disposal of electric and electronic equipment may involve sanctions.

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SIMBOLOGY
Class II isolation equipment
CE marking in conformity with EC directive 93/42/EEC and subsequent
changes
General warnings and/or specifications
Consult the instruction manual
Applied part type BF (Nebulizer, mouthpiece, nosepiece, pediatric
masck and Adult mask)
Conservation temperature: -25 ÷ 70°C
Keep in a cool, dry place
~
Alternate Current
Hz
Mains Frequency
I
ON
0
OFF
Lot Number
Serial Number
Identification device
IP21
Degree of protection an electrical device provides in the case of
accidental or intentional contact with the human body or with objects,
and protection in the case of contact with water.
1st DIGIT
PENETRATION OF SOLIDS
2nd DIGIT
PENETRATION OF LIQUIDS
Protected against solids having a
dimension greater than Ø 12mm
Protected against the vertical
flow of drops of water
MMAD = Mass Median Aerodynamic Diameter
GSD = Geometric Standard Deviation
NB: The measures and curves are not valid for the high viscosity suspension drug.

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CLEANING DEVICE
Use a soft dry cloth with not –abrasive and not –solvent detergents. The device's plug must be removed from the wall socket
before proceeding with any cleaning procedures.
CLEANING AND WASHING OF ACCESSORIES
Before using and/or after cleaning, pay special attention to ensure that all the accessories supplied with the device are intact.
Switch off the device before cleaning it and disconnect the mains cable from the electrical socket.
PREPARATION
1. Pull out the air tube from the nebulizer and leave it plugged into the air outlet nozzle of the device;
2. Rotate the upper part of the nebulizer anti-clockwise;
3. Use your fingers to disconnect the internal pisper at the bottom of the nebuliser.
CLEANING
Before and after each use proceed with cleaning all of the components of the nebulizer (with the exception of the air tube)
according to one of the two methods described below.
Method 1: Thoroughly clean the components for 5 minutes, using warm drinking tap water (about 40°C) and/or mild soap.
Method 2: Clean the components (except for the air tube) by immersing them in a solution with 60% water and 40% white
vinegar. When finished, thoroughly rinse with warm drinking water (approx. 40°C).
After cleaning, rinse thoroughly by removing the excess water and allow to air dry in a clean place.
DO NOT BOIL OR AUTOCLAVE THE AIR TUBE AND MASKS
DO NOT WASH ACCESSORIES IN A DISHWASHER
WASHING
If there are pathologies with risks of infection and microbial contamination, it is the end user’s responsibility to proceed with
suitable washing. The washing procedure can only be carried out if the components to be treated have undergone specific cleaning
(see chapter on cleaning).
Proceed as follows for the washing procedure:
-Fill a container, of a suitable size to contain all the individual components, with a solution of drinking water and disinfectant
(hypochlorite-based solution readily available in a pharmacy) by following the proportions indicated on the packaging of the
disinfectant itself;
-The period of time for which is to be immersed in this solution is indicated on the packaging of the hypochlorite solution in
accordance with the chosen concentration for preparing the solution;
-Rinse thoroughly with lukewarm drinking water to remove all traces of the solution.
Dry and store in a dry, dust-free environment.
-Dispose of the used solution according to the instructions provided by the manufacturer of the disinfectant solution.
STANDARD ACCESSORIES
ACCESSORIES
HI-FLO KIT –REF RE 300300
(Nebulizer HI-FLO, Adult Mask, Pediatric Mask, Air Tube and Mouth-piece,
Nosepiece)
For each individual patient it’s recommended to use the nebulizer for 6 months or for a maximum of 120 treatments.
The nebulizer must be replaced after a long period of inactivity, if it is deformed or broken, or if the nebulizer nozzle is blocked by
dry medicine, dust, ecc.. Only use the original nebulizer supplied by GIMA with the device
Use the “nose piece” accessory only if expressly indicated by your doctor and paying attention NEVER to introduce inside the nose
the nasal bifurcation, but only bring it as close as possible.
In the presence of infection or microbial contamination prone pathologies, we recommend using your personal accessories
and nebulizer (always consult your doctor).
The device is equipped with a filter that removes any impurities from the air that was sucked in by the compressor. The air filter
must be replaced every 25 hours of functioning or when it result particularly worn.
For replacement, lift the filter and replace with a new one. Only use original GIMA filter.
The mask and tube must be replaced as soon as the materials they are made of show signs of deterioration.
DON’T USE THE DEVICE WITHOUT AIR FILTER

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INSTRUCTION FOR USE
The device must be checked before each use in order to detect malfunctions
and / or damage caused by transport and / or storage.
During the inhalation must sit in an upright and relaxed position at a table
and not in an armchair, to avoid compressing the airways and therefore
compromising the effectiveness of the treatment.
It is recommended not to keep the device in your hands and / or to avoid
prolonged contact with the body of apparatus.
WARNING: Put the device on a flat and stable surface in order not to block
the cooling vents on the sides of the device.
Extract the power supply cable and insert the plug into the mains socket. It
is recommended to unwind the entire length of the power supply cable to
prevent dangerous overheating. If the power supply cable is damage and
must be replaced contact the GIMA technical service;
Open the nebulizer 2by unscrewing the lid;
Pour the medicine prescribed by the doctor into the nebulizer;
Re-close the nebulizer, re-screwing the lid;
Connect air pipe 5 to the air exit well 4;
Connect the other end of the pipe to the connection in the lower part of the
nebulizer;.
Connect the desired accessory to the nebulizer: child mask or adult mask,
mouth-piece or nosepiece;
Ensure that the supplied air filter (6) is present;
Press switch 1on position Ito proceede with nebulization;.
On completing of nebulization, press the switch on position 0 and remove
the plug from the socket;
Wash the nebulizer and its accessories as indicated in the cleaning charter;.
Place the cable and accessories inside the box.
Always use the nebulizer facing upwards so that substances and / or medicines cannot escape from the nebulizer during the
normal use.
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.
NEVER INHALE IN HORIZONTAL POSITION
NEVER BEND THE NEBULIZER OVER 60
1- Air Tube
2- Nebulizer Tank
3- Nebulization Nozzle
4- Nebulizer Top
5- Mouthpiece
6- Adult Mask
7- Pediatric Mask
8- Nosepiece

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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 Eolo 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 configuration (for example,
constantly and visually checking for the absence of anomalies or malfunctions).
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. The following tables supply information regarding the EMC (Electromagnetic Compatibility) characteristics of
the electro-medical device.
Guidance and manufacturer’s declaration – Electromagnetic Emissions
The EOLO Nebulizer is intended for use in the electromagnetic environment specified below. The customers or the user of
the EOLO Nebulizer should assure that it’s used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
Irradiated / Conducted emissions
CISPR11
Group 1
The EOLO Nebulizer 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
Class [B]
The EOLO Nebulizer can be used in all environments,
including domestic and those connected directly to the public
mains distribution that supplies power to environments used
for domestic scopes or environments feeds to you from
batteries.
Harmonic emissions EN 61000-3-2
Class [A]
Voltage fluctuations / flicker emissions
EN 61000-3-3
Complies
Guidance and manufacturer’s declaration – Immunity Emissions
The EOLO Nebulizer is intended for use in the electromagnetic environment specified below.
The customers or the user of the EOLO Nebulizer should assure that 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
± 6kV on contact
± 8kV in air
The device doesn’t
change its state
Floors should be wood, or ceramic tile. If
floors are covered with synthetic
material, the relative humidity should be
at least 30%.
Electrical fast
transient / burst
EN 61000-4-4
± 2kV power supply lines
± 1kV for input / output lines
The device doesn’t
change its state
Mains power quality should be that of a
typical commercial environment or
hospital
Surge
EN 61000-4-5
± 1kV differential mode
The device doesn’t
change its state
Mains power quality should be that of a
typical commercial environment or
hospital
Loss of voltage, brief
voltage interruptions
and variations
EN 61000-4-11
5%UT(>95% dip UT) for 0.5
cycle
40%UT(>60% dip UT) for 5
cycle
70%UT(>30% dip UT) for 25
cycle
<5%UT(>95% dip UT) for 5 sec
-
Mains power quality should be that of a
typical commercial environment or
hospital If the user of the EOLO Nebulizer
request that the appliance operates
continuosly, the use of a continuity unit is
recommended.
Magnetic field
EN 61000-4-8
3A/m
The device doesn’t
change its state
The power frequency magnetic field
should be measured in the intended
installation location to assure that it’s
sufficiently low.
Note UTis the value of the power supply voltage

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Guidance and manufacturer’s declaration – Immunity Emissions
The EOLO Nebulizer is intended for use in the electromagnetic environment specified below.
The customers or the user of the EOLO Nebulizer should assure that it’s used in such an environment.
Immunity Test
Level indicated by the
EN 60601-1-2
Compliance level
Electromagnetic environments -
guidance
Conducted Immunity
EN 61000-4-6
3Vrms 150kHz to 80Mhz
(for non life-supporting
devices)
V1= 3 V rms
The portable and mobile RF communication
devices, including cables, must not be used
closer to the EOLO device, than the
separation distance calculated by the
equation applicable to the transmitter
frequency. Recommended separation
distance
d = [3.5 / V1]
P
d = [12 / E1]
P
from 80 MHz to 800MHz
d = [23 / E1]
P
from 800 MHz to 2.5 GHz
Where P is the maximum nominal output
voltage of the transmitter in Watt (W)
depending on the manufacturer of the
transmitter and the recommended
separation distance in metres (m). The
intensity of the field from the fixed RF
transmitters, as determined by an electro-
magnetic study of the sitea), could be lower
than the level of conformity of each
frequency interval b). It is possible to check
for interference in proximity to devices
identified by the following symbol:
Radiated Immunity
EN 61000-4-3
3V/m 80MHz to 2.5GHz
(for non life-supporting
devices)
E1= 3 V / m
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 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 EOLO Nebulizer is intended to operate in an electro-magnetic environment where RF irradiated interferences are
under control. The client or operator of the EOLO device can help prevent electro-magnetic interference by keeping a
minimum distance between the portable and mobile RF communication devices (transmitters) and the EOLO 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)
150 kHz to 80 MHz
d = [3.5 / V1]
P
80 MHz to 800 MHz
d = [12/E1]
P
800 MHz to 2.5 GHz
d = [23/E1]
P
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.

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MAINTENANCE
The EOLO nebulizer does not need maintenance or lubrication.
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. It is necessary to check functioning and instrument before every use.
Connect cable to electrical network and turn switch on. Close the compressor mouthpiece with a finger and verify that loud noises
are not present, these can indicate wrong functioning. Verify that the atomiser is not damaged by previous use (it was badly put
away or badly knocked).
A protection fuse (F 1.6 A L 250V) not reachable from exterior protects the instrument.
For fuse replacing, please make reference to manufacturer technical personnel.
Gima S.p.A. will provide upon request electric diagrams, components list, description, setting instructions and any other information
that can help the technical assistance staff for product repair.
In the event that the service personnel has to replace the power cord is recommended that the correct connection and proper
fastening of the same component.
Fault type
Cause
Solution
1. Low Nebulization
Clogged Nebulizer Tank
Clean and disinfect the nebulizer tank as
explained in the instruction manual
2. Low Nebulization
Clogged Nebulizer Tank
If cleaning was not succesful change cruet
3. Absence of Nebulization
Clogged Nebulizer Tank
Check that the nebulizer contains medication;
Make sure that the nebulizer is not clogged;
Check the connection between the compressor
air outlet port and the accessories
4. Slow Nebulization
Highly dense drug
Dilute drug in physiological liquid
5. Noisy Device
Extended use
Call retainer or manufacturer GIMA
Fault 1 - 2 - 3 - 4 - 5
No solution with previous items
Call retainer or manufacturer GIMA
If the unit doesn’t nebulizer once the above conditions have been checked, we suggest to contact your dealer or technical service
GIMA.
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 TECHNICL SERVICE CHECKING,
APPEARS TO BE TAMPERED.
ANY MINIMAL MODIFICATION / 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 SUBSEQUENT
CHANGES) AND ITS NORMATIVES.
RULES FOR RETURNING AND REPAIRING
COMPLYING WITH THE NEW EUROPEAN RULES, GIMA INDICATES THE IMPORTANT POINTS TO PROTECT INSTRUMENT
AND OPERATORS HYGIENE. THESE RULES MUST BE RESPECTED IN ORDER TO GUARANTEE HYGIENE AND SAFETY TO ALL
THE PEOPLE OPERATING WITH THE INSTRUMENT TO OBTAIN QUALITY AND WELL BEING.
Every returned instrument will be hygienically checked before repairing. If GIMA finds instrument not suitable for repairing due
to clear signs of internal or external contamination, the same will be returned to customer with specification of NOT REPAIRED
INSTRUMENT, accompanied by an explanation letter.
GIMA will decide if contamination is due to bad functioning or misuse. If contamination is due to bad functioning, GIMA will
substitute the instrument, only if SALE RECEIPT and STAMPED GUARANTEE accompany the same.
GIMA is not responsable for contaminated accessories, they will be substitute at customer's expenses.
For this reason it is COMPULSORY to carefully disinfect the external part of the instrument and accessories with a cloth soaked in
methylated spirits or hypochlorite-based solutions. Put the instrument and accessories in a bag with indication of disinfecting. We
also request to specify the kind of fault, in order to speed up repairing procedures.
To this end, please read the instructions carefully in order to avoid damaging the equipment through improper use.
Always specify the fault encountered so that GIMA can establish whether it falls into the category of the faults covered by the
guarantee.
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