ORDISI FV SM Series User manual

Maintenance and
Functioning manual
Tecnologia 2 –nave 7
08780 Palleja
Barcelona - Spain
Tel. [phone]
Mom-24 Fax [phone]
Edición 6 [email protected]om
Fecha 2020/04/024 www.ordisi.com

Page 2of 10
INDEX
1.-INTRODUCTION
2.-MANUFACTURER’S RESPONSABILITIES
3.-PARTS DESCRIPTION
4.-INSTALLATION AND COMMISSIONING
5.-CLEANING AND STERILISING
6.-CARE AND MAINTENANCE
7.-TECHNICAL SPECIFICATIONS
8.-SPECIAL ACCESSORIES
9.-DIAGRAMS AND SCHEMATICS
10.-TROUBLESHOOTING
11.- TECHNICAL SPECIFICATION, EMC INFORMATION
1.-INTRODUCTION
Thank you for your trust in ORDISI S.A. and for your purchase of a FUTURVAC series aspirator.
Before you start the aspirator for the first time, please read these instructions carefully. If you have any questions, please
contact your nearest ORDISI distributor or contact us to our head office directly:
ORDISI, S.A.
Tecnologia, 2
08780 Palleja (Barcelona) - España
Tel.: [phone]
Fax.: [phone]
e-mail: [email protected]
2.- MANUFACTURER’S RESPONSABILITIES
ORDISI S.A. is responsible for the correct operation and safety of this aspirator provided the following conditions are met:
•The equipment is operated in accordance with this instruction manual
•Parts and consumables requiring preventive replacement are replaced only with original parts and/or ORDISI S.A.
authorised parts.
Resetting adjustments, upgrades, modifications and/or repairs are performed by companies or persons authorised by
ORDISI S.A.
3.- PARTS AND DESCRIPTIONS FRONT-END
The vacuum can be called with several references depending on the bottles that is equipped with:
•FV-1202SM –FV-1202SH: surgical vacuum with 2 flasks of 1L.
•FV-1220SM –FV-1220SH: surgical vacuum with 2 flasks of 3L.
•FV-1303SM –FV-1303SH: surgical vacuum with 2 flasks of 1L and one flasks more security flask of 1L.
•FV-1321SM –FV-1321SH: surgical Vacuum with 2 flasks of 3L and one flasks more security flask of 1L.
•FV-1240SM –FV-1240SH: surgical Vacuum with 2 flask of 4 L
FV-1303SM, FV-1303SH and FV-1321SM, FV-1321SH models have an extra flask of 1L with the reference FV010019A.
The housing have a modification for incorporate the flask in the correct positioning. This modification of the case has the
ref. FV010001 / 3.
FV-1202SM, FV-1202SH and FV-1220SM, FV-1220SH models don’t have an additional flask. The reference of the housing
is FV010001/2.
ENGLISH

Page 3of 10
FRONT
1.- Luminous ON/OFF switch
2.- Vacuum regulator
3.- Vacuum gauge
4.- Vacuum connector
5.- Control panel with synoptic board
6.- Bacterial filter
7.- Collection bottle
8.- Additional 1 litre safety bottle (optional)
9.- Air Vent
10.- Transportation handle
11.- Anti-static caster wheels with breaking function.
12.- Anti-static caster wheels
BACK
12.- Anti-static wheels
13.- Air outlet
16.- Air vent
17.- Power cord spooler
18.- Specs plate
19.- Power cord
20.- Power fuse
21.- Protective and equipotent ground connector
CAP, CONNECTORS ANDSAFETY VALVE
22.- Collection bottle cap
23.- Connector ‘to patient’
24.- O-ring
25.- Vacuum connector
26.- O-ring
27.- Valve holder
28.- Safety valve
29.- Seal washer
30.- Cap’s O-ring
31.- Anti-splashing tube

Page 4of 10
4.- INSTALLATION AND OPERATING
4.1.- UNPACKING
Upon reception of the equipment, if package is seen as damaged, immediately check if device has been affected. If
damages are confirmed, immediately refer them to sender.
4.2.- START-UP
Not to use in explosive atmospheres like the anaesthetic produced ones by inflammable.
1) Check the electrical installation of the room where the equipment is being installed, and make sure it complies with the
IEC (UNE) regulations. Installations should have a proper earth connection as well as a correct voltage (noted in the
specs plate). Place the aspirator in the best suitable location of the room; making sure that the distance between the
aspirator and the walls of the room is at least 15 cm.
2) With the aspirator, you will find a aspiration set for a single use, (GRAVE RISK OF INFECTION IF USED IN
DIFFERENTS PATIENTS) composed by 2 meters of bulb tube, and one cannula that is connected to an extreme of the
tube. Enter the other extreme of the tube in the patient connector Nº 23 (to see point 2 section 4.3), indicated in the
bottle plug, and turn on the equipment. The cannula adds a regulatory hole, and through digital pressure may regule
the aspiration level. References for new orders: US0114020 bulb tube with cannula (20 units)
3) Vacuum regulator (No. 2) makes it possible to increase or to decrease vacuum level.
4) Vacuum gauge (No. 3) will indicate, at all times, the vacuum level that is received by the patient, (tolerance ±1.6%). It
is recommended that in normal conditions, the calibration of the vacuum-gauge is made once every two years.
5) The FV series vacuum cleaners are intended to be used in temperatures ranging between 15ºC and 35ºC
and a relative humidity of less than 70%. And at 1bar pressure.
4.3.- SUGGESTED USE
1) WARNING: Avoid filling the collection bottle beyond 80% of its capacity, as overflowing and fluids entry into the
pump may occur if the collection bottle is overfilled. Should this happen, we recommend disassembling and cleaning of
the pump head by the authorised technical service.
2) Do not use extremely long suction tubes as they tend to bend and collapse blocking the suction process. On another
note, there is a risk of the formation of bends in which aspirated substances may build up, producing a possible source
of contagion and infection. Periodically replace the tube of aspiration by a specific tube for this one assignment (it must
take to noticeable CE of conformity fulfilling the norm UNE EN 1617 of drainage tubes). Verify when replacing these
and before coming to the aspiration that the connection is watertight and flights do not take place. We recommended
the use of the following tubes of aspiration:
- PVC tube minimum inner diameter 6 mm by 9 mm of outer diameter.
- Silicone tube minimum inner diameter 6 mm by 10 mm of outer diameter.
- Evitar que el paciente se apoye en los tubos de aspiración, de forma que obstruya la misma.
3) After each use, the cap (No. 22), safety valve (No. 28) and bottle must be cleaned and sterilised
4) Do not start the aspirator if there is vacuum in the circuit. Before turning it on, bring vacuum level to 0.
5) The use of a reputable antifoaming agent should be considered as to avoid foam inside the bottle hindering a correct
filling read out.
6) Never connect any device, such as ventilators, aerosol generators, etc. to the air vent.
7) If the bottle is overfilled and the safety valve (No.28) is engaged, the machine will stop suctioning. Stop the aspirator
using the switch, bring the vacuum level to 0 by using the vacuum regulator (No.2) and change or empty the bottle.
8) The biological risk waste will be removed following the protocol of the hospital waste management.

Page 5of 10
4.4.- FURTHER INFORMATION CONCERNING ASPIRATOR INTENDED USE
Tough surgical aspirator with large workflow capability. Because if its power and flow rate, is indicated for:
•Major surgery.
•Medium surgery.
•Endoscopic suction.
•Gynaecological suction.
•Suction in hospital wards.
This equipment is not appropriate to work in operating rooms where it suspects that can have inflammable atmosphere
risk
The contraindications and/or precautions, and possible adverse effects, according to clinical evaluation are the followings:
•Critical elements to consider by a surgeon: the quantity of fluid that will have to be extracted and precautions to
take for getting that this extraction isn’t traumatic.
•As a normal associated effects with the aspiration are described in the followings: passenger edema, pain, smaller
scars and drilling intraperitoneal / intrathoracic.
•For a bibliography review, the described complications are: infection, haematomas, blood loss.
4.5 TRANSPORT
If you have the need of transport a model FV vacuum cleaner, first make sure that the device is turned off, unplug the power
cable and wrap it around the cable reel provided for this purpose. Once this is done, unlock the wheel brake and use the
handle (10) for transport, always push the vacuum cleaner from its rear. Once you have deposited it in its new location, do
not forget to lock the wheels again with the brake.
5.- CLEANING AND DISINFECTION / STERILIZATION
5.1.- HOUSING
Before any intervention, disconnect the computer from the network.
Use personal protective equipment as directed by the unit of occupational hazards and preventive medicine.
The outer casing of the equipment can be washed using a mild detergent and a damp cloth.
Disinfect is necessary using a disinfectant.
The probes and suction tubes are single use must not be reused.
5.2.- COLLECTING BOTTLE
Collecting bottle (No. 7) and its cap (No. 22) together with the valve and valve holder (No. 27-28), are delivered non-
sterilised. It is recommended that before their first use, and after each operation, the units be sterilised.
NOT USE BLEACH OR SIMILARS COMPOUNS
Not to use liquid disinfectants that contain in their composition acetone or derivates, these can affect the technical
characteristics of the bottles and polycarbonates caps.
To proceed to washing and disinfection / sterilization of the bottle, cap, valve and valve holder can be used:
• Washing: Always perform this operation using a neutral detergent and eliminating all biological fluids
• High Level Disinfection: Disinfect after each use with a disinfectant.
• if it is necessary Sterilize by steam (validated cycle of 121°C at 1atm pressure for 30 minutes).
The collecting flask are made of polycarbonate that guarantees the resistance at this temperature, after subjecting to
several cycles, and by the use, it can be seen that the transparency gradually lost, this will indicate that the container is
losing its original characteristics and would be appropriate to their replacement.

Page 6of 10
6.- CARE AND MAINTENANCE
6.1.- BACTERIAL FILTER
The bacterial filter included in your equipment is a closed system filter, It is NON REUSABLE, (GRAVE RISK OF
INFECTION IF USED IN MANY PATIENTS).
NEVER USE THE ASPIRATOR WITHOUT THE BACTERIAL FILTER IN PLACE
6.2.- CHANGING THE FUSE
If the machine did not work and the ON/OFF switch was not illuminated while connected to the electrical network, with the
ON/OFF switch (No.1) was in position “1”, the fuse condition should be checked following these instructions:
1) Remove the covers of the fuse-holders (No. 20) with a screwdriver.
2) If damaged, replace them with news ones.(Ref. RC009955).
3) Place the covers back after positioning the fuse.
7.- TECHNICAL CHARACTERISTICS
•High vacuum aspirator
•High flow aspirator
•Dry piston vacuum pump
•Flow / Maximum vacuum:
➢serie SM: 2,7 m3/h (45 l/min)
90 Kpa (680 mmHg)
➢serie SH: 5,4 7 m3/h (90 l/min)
93 Kpa (700 mmHg)
•Collecting bottle capacity: 1 or 3 litres
•Maximum collection capacity: from 2 to 9 litres
•Measurements: 50 x 43 x 80 cm
•Approximate weight: 22 Kg
•Power: 150 VA (SM) / 350 VA (SH)
•Voltage: 220V / 50 Hz
•Fuses: 2 of 2A Type F
•Equipment of I Class B type.
•Average life: 10 years
USING SYMBOLS:
Refer to enclosed documents
Earth ground (interior)
Equipotential
Type B equipment
Year of Manufacture
CE registered by a Standardizing Body
Selective collection of electrical apparatuses
Forbidden to sit
Prohibited from getting on
8.- SPECIAL ATTACHMENTS
•ON/OFF pedal, with an electrical micro-switch and 3,5 metre long power cord. Ref. FV010052
•Hydrophobic bacterial filter. Ref. FB-193, 1 unit bag.
9.- DIAGRAMS AND SCHEMATICS
ORDISI, S.A., on customer request, will supply the parts lists and their description as well as their instructions of calibration,
and any other additional information that may be needed by the qualified technical staff repairing the machine.
Attached to this manual, you will find the pneumatic system diagram and the exploded view of the aspirator.

Page 7of 10
9.1.- PNEUMATIC DIAGRAM
1) Pump
2) Control dials
3) Vacuum regulator
4) Vacuum gauge
5) Bacterial filter
6) Safety bottle
7) Collecting bottle
8) Towards patient
9) Air outlet
9.2.- CIRCUIT SCHEMATIC
9.3.- EXPLODED VIEW
See page 9 & 10
10.- TROUBLESHOOTING
FAILURE OR MALFUNCTION
CAUSE
SOLUTION
Equipment starts up but doesn’t
aspirate.
Regulation control is open.
Close control.
Suction tube wrongly inserted..
Insert correctly.
Cap improperly adjusted.
Adjust properly.
Equipment starts up but suction is not
enough or inexistent.
Bacterial filter is saturated.
Change filter.
Failure continues..
Entry of liquid inside the pump.
Disassembly and cleaning of pump
head by Technical Services.
Equipment doesn’t start up nor the
luminous switch lights up.
Examine the fuse possible deterioration and
the power plug.
Replace the fuse or the plug.
Failure continues.
?
Contact Technical Services.

Page 8of 10
11.- TECHNICAL SPECIFICATION, EMC INFORMATION
Guidance and manufacturer’s declaration –electromagnetic emissions
The system is intended for use in the electromagnetic environment specified below.
The customer or the user of the equipment SHould assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Grup 1
The equipment uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The equipment is suitable for use in all establiSHments, including
domestic establiSHments (not industrially) and those directly connected
to the public low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC61000-3-2
Class A
Voltage fluctuations/ flicker
emissions
IEC61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
The equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the equipment SHould assure that it is used in such an environment.
IMMUNITY test
IEC 60601
test level
Compliance level
Electromagnetic environment
guidance
Electrostatic
discharge (ESD)
IEC61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors SHould be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
SHould be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power supply lines
±1KV for input/output lines
±2kV for power supply
lines
Mains power quality SHould be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV line(s) to line(s)
±2kV line(s) to earth
±1kV line(s) to line(s)
±2kV line(s) to earth
Mains power quality SHould be that of a
typical commercial or hospital
environment.
Voltage dips, SHort
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5%UT (>95% dip in UT) for
0,5 cycle
<40%UT (>60% dip in UT) for
5 cycles
<70%UT (>30% dip in UT) for
25 cycles
<5%UT (>95% cycles UT) for
5 s
Ídem
Mains power quality SHould be that of a
typical commercial or hospital
environment. If the user of the
equipment requires continued operation
during power mains interruptions, it is
recommended that the equipment be
powered from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
The power frequency magnetic field
SHould be measured in the intended
installation location to assure that it is
sufficiently low.
VACCUM VARIATION IN RELATION TO ALTITUDE ABOVE SEA LEVEL, AT A
TEMPERATURE OF 22ºC
Altitude above sea
level
FV-SH model
FV-SM model
Ph (mmhg)
Ph (kPa)
Ph (mmhg)
Ph (kPa)
0 m
700
93,3
680
90,6
500 m
660
88,1
641
85,5
1000 m
623
83,1
605
80,7
1500 m
588
78,4
571
76,2
2000 m
555
74
539
71,9
2500 m
524
69,8
509
67,8
3000 m
495
65,9
480
64

Page 9of 10
9.3.- PLANO DE DESPIECE

Page 10 of 10