Air Liquide SP20 Bedienungsanleitung Seite 5

Surgical Aspirator Air Liquide Medical Systems
model: SP20 - SP30 - SP40 - SP20 12V - SP30 12V
The Air Liquide Medical Systems Surgical Aspirator was designed for small surgical aspirations, for
treating tracheostomatised patients at home, and for pharyngeal use.
The Air Liquide Medical Systems series of surgical aspirators is not suitable for Chest drainage.
GENERAL CHARACTERISTICS
The aspirator is easy to use and to clean, it has an ergonomic and compact design that permits access
to the main functions and controls, which are always clearly visible, the pump is not lubricated and
does not require maintenance. The vacuum regulation knob allows adjusting the values according to
patient requirements.
A number of models are available, based on the suction power and capacity of air intake matched to
the collection tanks with various capacities.
Each Surgical Aspirator has a tank for collecting suctioned liquids, connection tubes to the apparatus
and a supplementary safety valve to protect the system from any overflow of liquids that could come
about on the main collection tank.
The Surgical Aspirator is manufactured in accordance with ISO 10079-1 regulations and is checked
by the certifying organisation IMQ as it is a Class IIB Medical Apparatus as per the European Directive
93/42 CEE governing medical devices, accepted in Italy by Law Decree 46/97 and subsequent
amendments.
This product complies with the restriction on the use of certain hazardous substances in electric
and electronic devices (European Directive 2011/65/EU)
Before using the apparatus check the wholeness of the product in its packaging. If it has been
damaged during transport please inform the dealer.
Read the instructions found in this Instructions Booklet carefully before using the Surgical Aspirator.
Instructions differing from those stated in this manual are not permitted. Different procedures can
reduce the safety level of the apparatus.
Any modification to the apparatus can be carried out only if approved by AIR LIQUIDE MEDICAL
SYSTEMS S.r.l and is in accordance with the procedures supplied.
ENVIRONMENTAL USE CONDITIONS
Room temperature: from 5°C to +40°C
Relative humidity: from 15% to 93%
Atmospheric Pressure: from 700 to 1060 hPa
Type of Operation: continuous
USE INSTRUCTIONS
The surgical aspirator box contains:
• Suction unit complete with feed cable
• Liquids collection tank
• Supplementary safety valve
• Connection pipes
• Reduction fitting for the *cannula to the vessel suction connection tube
• Instructions booklet
NB. The suction cannula that must enter the body is not included. It must be purchased separately.
Check that on the box it states that it conforms to the ISO 10993-10 regulations governing
biocompatibility of materials.
SUCTION UNIT
(fig.1, fig.2)
Manufactured with fireproof materials, the suction unit contains the vacuum pump. The available
instrumentation is distributed as follows:
On one side of the unit there is:
1. Vacuum regulation knob
2. Vacuometer with scale in kPa
3. Main switch, if the apparatus is not in use the switch must always be in position "O" "off"
4. Electricity feed plug or feed cable output
On the lower back panel there are:
5. the suction socket
6. vessel holder bar for vessels of 1000 cc and 500 cc
6a vessel holder bar for vessels of 3500cc
6b vessel holder basket for single use vessels
7. supplementary safety valve
The technical data plate is found underneath the apparatus. Before switching on the apparatus check
that the voltage stated on the plate is the same as that supplied in the mains, use the apparatus only
with regular electrical systems.
CLEANING THE APPARATUS
Always disconnect the power plug before cleaning and check that the switch is on O "off".
The suction unit can be cleaned using a soft cloth and non-abrasive detergents, while it can be
disinfected with the use of cold disinfectants, read the warnings stated on the sterilising solution
packaging as this could be incompatible with the ABS fireproof material with which the apparatus
has been made.
It is advisable to clean the apparatus before and after use.
Warning! Do not place the apparatus in water and do not pour water or other solutions directly onto
the apparatus.
REPLACING THE FILTER (fig.3)
Always disconnect the power plug before replacing the filter and check that the switch is on 0 "off".
The filter situated under the apparatus has the sole purpose of preventing the solid particles that have
been suctioned to be freed into the atmosphere.
It is recommended that the filter be replaced every 2 years or when extraordinary maintenance is
carried out by an authorised centre.
Should the apparatus undergo variations in function check whether the filter is dirty.
The filter must not be washed but blown with compressed air.
Should the filter become wet, it will be necessary to replace it.
To replace remove the filter holder lid and remove the filter, insert a new one and press the lid to close
the filter into its housing.
REPLACING THE FUSE (fig.4)
Always remove the power plug before doing this and check that the switch is on O "off".
ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • ENGLISH • EN
The fuse must be replaced when an electric discharge has been released towards the apparatus and
the fuse, acting as a safety organ, has burnt out.
The fuse must be replaced carefully in order to avoid dangers. The fuse could be located near the
feed socket or under the apparatus, use a tool, (not included) and apply slight pressure to pry open
the fuse box.
Replace the damaged fuse with a new one being careful that the values shown on the new fuse are the
same as those stated on the technical data card. Replace the box using slight pressure.
LIQUIDS COLLECTION TANK
Depending on the version purchased the suctioned liquids container can have various sizes: vessels
available according to models 500 cc, 1000 cc and 3500 cc and single use kits.
The containers were designed and manufactured for "high flow" and "high vacuum" applications."
( high flow / high vacuum ). Reference classification EN ISO 10079-1.
Manufactured in plastic materials, they can be sterilised hot or cold, are equipped with an overflow float
and connectors which allow connecting the collection tank to the suction line and the patient.
There are two attachments on the lid for tubes identified by the wording "TO UNIT" and "TO PATIENT",
these indicate where the tubes must be connected.
The vessel measuring unit is shown in ml ( millilitres ). The maximum vacuum value applied -95 kPa
The reading scale for vessels of 500 cc and 1000 cc is divided into intervals of 125 ml, for the vessel
3500 cc the interval is of 250 ml.
For environmental conservation conditions of the collection tanks: "See warnings"
NB. If you have chosen to use the "MONOKIT" version, the instructions for use for good maintenance
and operation are enclosed.
These instructions are not found in this manual.
MAINTENANCE (fig.5)
The collection tanks for suctioned liquids are manufactured in polycarbonate, which guarantees long
periods of use without needing specific maintenance.
Nonetheless when periodic checks by the user show the need for repairs, this must done only by
authorised staff and in accordance with the following instructions:
Clean the tank and its parts regularly and accurately.
Replace any damaged or faulty parts using only original spare parts.
Before using once again check that all the vessel parts have been assembled. The absence of some
components can jeopardise operations and product safety.
The vessel comprises:
1) Graduated tank
2) Vessel lid
3) Float holder
4) Float
5) Valve seal gasket
6) Lid gasket
Place the float (4) complete with its valve (5) into the float holder (3) and place everything into the lid (2).
Turn the lid 180° to check that the float (4 and 5) moves freely, if it blocks then widen the float holder
slightly with your fingers (3). Place the gasket (6) inside its housing in the lid (2) and screw everything
onto the graduated tank (1).
This system allows blocking the liquids suctioned in excess, preventing them from entering the suction
pump, it is advisable to empty the vessel before the liquid reaches the float.
CLEANING AND DISINFECTING
Before using the collection tank once again it must be cleaned and sterilised according to the following
instructions:
Separate the fundamental components of the tank such as graduated vessel, lid, float and gaskets.
Thoroughly wash all surfaces using warm water no warmer than 60°C.
Carefully dry the components with a soft, non-abrasive cloth.
Place the parts in an autoclave and start the sterilization cycle with steam at a temperature of 121°C
for at least 15 minutes being careful to place the graduated vessel upside down (with the bottom
pointing upwards).
After sterilisation, allow the components to cool to room temperature and check that they are not
damaged, then reassemble the suctioned liquids tank following the dismantling instructions in reverse.
The apparatus is now ready to be used once again.
Do not use solvents or abrasive products to clean, these would irretrievably damage the components
made of plastic in the apparatus.
Do not use inflammable products.
During sterilisation in autoclave do not place weights on the objects.
The mechanical resistance of the product is guaranteed up to 20 cleaning and sterilising cycles at the
conditions stated in ISO 10079-1 regulations.
Exceeding these limits could lead to the deterioration of physical-mechanical properties of plastic
materials and therefore the replacement of the entire vessel is recommended.
Check the device every six months or in accordance with hospital procedures in order to guarantee
good operation and perfect effectiveness of the suctioned liquids collection tank.
SUPPLEMENTARY SAFETY VALVE (fig.6)
The supplementary safety valve is a device that is able to intervene in case of an initial failure of the
collection tank float to avoid aspirated liquids flowing into the suction pump and irretrievably damaging
it. The supplementary safety valve must be screwed onto the threaded connector and blocked with
its knob before use. If the supplementary safety valve activates it means that the collection tank float
does not work.
Each time the supplementary valve is activated it must be completely dismantled and cleaned.
Before assembling the safety valve check that the problem with the tank float has been solved.
The valve comprises:
1) Valve body
2) Float holder
3) Float
4) Valve seal gasket
5) Valve lid seal gasket
6) Lid valve
7) Seal basket between the threaded connector and supplementary safety valve.
MAINTENANCE (fig.7)
When the valve is assembled check that all the parts are whole.
Check that the float moves freely vertically without friction.
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