Cheiron Victoria
Cheiron Victoria
Type: Victoria
Model:
Victoria Portable
Victoria Versa
Victoria Thorax
Victoria Lipos
Victoria Economy
Version: CH-02-10-220224_V_IFU.docx
Table of contens
1 GENERAL INFORMATION............................................................................................4
2 TECHNICAL DATA ........................................................................................................5
3 AMBIENT CONDITIONS ...............................................................................................7
3.1 Device operation ambient conditions .............................................................................7
3.2 Transport ambient conditions.........................................................................................7
3.3 Storage ambient conditions ...........................................................................................7
4 TECHNICAL DESCRIPTION OF THE DEVICE .............................................................8
4.1 Device classification.......................................................................................................8
4.2 Electrical part .................................................................................................................9
4.3 Pneumatic part ...............................................................................................................9
5 SYMBOLS AND THEIR EXPLANATION .....................................................................11
6 ABBREVIATIONS AND TERMS USED ON THE DEVICE ..........................................12
7 WARNINGS, CAUTIONS AND SAFETY INSTRUCTIONS .........................................12
7.1 Warnings......................................................................................................................12
7.3 General Instructions .....................................................................................................15
8 DESCRIPTION ............................................................................................................16
8.1 Introduction ..................................................................................................................16
8.2 Basic information on the device ...................................................................................16
8.3 Indications....................................................................................................................17
8.4 Contraindications .........................................................................................................17
8.5 Authorized users ..........................................................................................................17
8.6 Handling the device .....................................................................................................17
9 VIEWS OF THE DEVICE .............................................................................................18
9.1 Contents of standard Victoria device delivery ..............................................................21
9.2 Medical devices (MD) available for Victoria device .......................................................21
9.3 Optional accessories available for Victoria devices ......................................................25
10 THE DEVICE CONFIGURATIONS ..............................................................................32
10.1 Victoria Portable ..........................................................................................................32
10.2 Victoria Versa ..............................................................................................................32
10.3 Victoria Lipos ...............................................................................................................33
10.4 Victoria Economy .........................................................................................................33
10.5 Victoria Thorax .............................................................................................................34
11 DEVICE PREPARATION FOR USE ............................................................................35
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11.2 Function Test ...............................................................................................................35
11.3 External Suction Circuit Assembly ...............................................................................36
11.4 Interconnection of Two Suction Jars ............................................................................36
11.5 Starting up and disconnecting the device ....................................................................37
11.6 Leak Test .....................................................................................................................37
12 TROUBLESHOOTING .................................................................................................38
13 CLEANING AND MAINTENANCE ...............................................................................39
13.2 Replacement of suction jars .........................................................................................39
13.3 Device cleaning ...........................................................................................................40
13.4 Device disinfection .......................................................................................................40
13.5 Suction jar cleaning and sterilization ............................................................................41
14 WARRANTY AND POST-WARRANTY SERVICE .......................................................42
15 RECYCLING ................................................................................................................42
15.1 Device disposal............................................................................................................42
16 PRODUCT NAMES AND ORDERING NUMBERS ......................................................43
16.2 Medical devices ...........................................................................................................43
16.3 Optional device accessories ........................................................................................45
17 EMC .............................................................................................................................46
18 LIST OF REVISIONS ...................................................................................................50
19 MANUFACTURER’S / SUPPLIER’S CONTACT DATA ...............................................50
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1 GENERAL INFORMATION
IMPORTANT:
PLEASE READ THE USER’S MANUAL CAREFULLY BEFORE USING THE
ELECTRIC SUCTION DEVICE VICTORIA AND KEEP IT FOR FUTURE
REFERENCE
The electric suction device Victoria – further in the text the device.
The electric suction device Victoria is designed to remove liquids, solid particles and
gases by means of vacuum. The device is intended to be used by medical service
providers (operating theatres, hospital wards, etc.).
The electric suction device Victoria may only be used in the manner described in this
User’s Manual. CHEIRÓN a.s. warrants the trouble-free operation of the system on the
sole precondition that the device is used with the original accessories.
Before commissioning the device, please familiarize yourself with and follow the
warnings and safety instructions. This User’s Manual must be available with the device
at all times for reference.
Caution
This User’s Manual contains general instructions concerning the operation of the
product. Any matters concerning medicine are within the doctor’s competence.
CHEIRÓN a.s. only assumes liability for impacts on the GENERAL SAFETY, reliability
and performance of the device on the precondition that it is used in compliance with this
User’s Manual.
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2 TECHNICAL DATA
MODEL
TECHNICAL VERSA LIPOS PORTABLE THORAX ECONOMY
DATA 230 VAC 230 VAC 230 VAC 230 VAC 230 VAC
Medical device
class IIa IIa IIa IIa IIa
Device weight
12 kg 12 kg 12 kg 12 kg 12 kg
– suction device
Device weight
Portable version
– including 36 kg 36 kg
only
36 kg 36 kg
accessories
Mobile stand Yes Yes N Yes Yes
Suction device
dimensions 440 x 300 x 310 440 x 300 x 310 440 x 300 x 310 440 x 300 x 310 440 x 300 x 310
(W x H x L)
Permanent Yes Yes Yes Yes Yes
operation
Acoustic power
(58.6 ± 3.2) dB (58.6 ± 3.2) dB (58.6 ± 3.2) dB (58.6 ± 3.2) dB (58.6 ± 3.2) dB
level
Device operation
Yes Yes Yes Yes Yes
visual signalling
Double over-
Yes Yes Yes Yes Yes
suction
protection
Max. vacuum
level (high (−92 ± 5) kPa (−93 ± 5) kPa (−92 ± 5) kPa (−92 ± 5) kPa (−92 ± 5) kPa
vacuum)
Free air flow-rate
(40 ± 5) L/min (50 ± 5) L/min (40 ± 5) L/min (40 ± 5) L/min (40 ± 5) L/min
(high flow-rate)
Use of limiting
water valve for N N N A N
thorax drainage
Vacuum range for
thorax drainage
N N N 0–40 cmH2O N
Voltage 230 VAC 230 VAC 230 VAC 230 VAC 230 VAC
Frequency 50/60 Hz 50/60 Hz 50/60 Hz 50/60 Hz 50/60 Hz
Rated power input 180 VA 180 VA 180 VA 180 VA 180 VA
2x T 2x T 2x T 2x T 2x T
Nominal fuse value 0.8AL/250 V 0.8AL/250 V 0.8AL/250 V 0.8AL/250 V 0.8AL/250 V
Electric shock
protection class I I I I I
IP code 32 32 32 32 32
Vacuum gauge 1.6 % 1.6 % 1.6 % 1.6 % 1.6 %
precision class
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Tab. 3: Technical data for the device 120 V models
MODEL
TECHNICAL
VERSA LIPOS PORTABLE THORAX ECONOMY
DATA
120 VAC 120 VAC 120 VAC 120 VAC 120 VAC
Medical device
IIa IIa IIa IIa IIa
class
Device weight
12 kg 12 kg 12 kg 12 kg 12 kg
– suction device
Device weight
Portable version
– including 36 kg 36 kg
only
36 kg 36 kg
accessories
Mobile stand Yes Yes Ne Yes Yes
Device
dimensions 440 x 300 x 310 440 x 300 x 310 440 x 300 x 310 440 x 300 x 310 440 x 300 x 310
(W x H x L)
Permanent Yes Yes Yes Yes Yes
operation
Acoustic power
(58.6 ± 3.2) dB (58.6 ± 3.2) dB (58.6 ± 3.2) dB (58.6 ± 3.2) dB (58.6 ± 3.2) dB
level
Device
Yes Yes Yes Yes Yes
operation visual
signalling
Double over-
Yes Yes Yes Yes Yes
suction
protection
Max. vacuum
level (high (−92 ± 5) kPa (−93 ± 5) kPa (−92 ± 5) kPa (−92 ± 5) kPa (−92 ± 5) kPa
vacuum)
Free air flow-rate
(40 ± 5) L/min (50 ± 5) L/min (40 ± 5) L/min (40 ± 5) L/min (40 ± 5) L/min
(high flow-rate)
Use of limiting
water valve for N N N A N
thorax drainage
Vacuum range for
thorax drainage
N N N 0–40 cmH2O N
Voltage 120 VAC 120 VAC 120 VAC 120 VAC 120 VAC
Frequency 60 Hz 60 Hz 60 Hz 60 Hz 60 Hz
Rated power input 180 VA 180 VA 180 VA 180 VA 180 VA
Electric shock
protection class I I I I I
IP code 32 32 32 32 32
Vacuum gauge 1.6 % 1.6 % 1.6 % 1.6 % 1.6 %
precision class
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Note:
The maximum vacuum level (−92 ± 5) kPa is related to the sea level with atmospheric
pressure 101.325 kPa. Deviations may occur in dependence on the local conditions,
namely the values of atmospheric pressure, altitude, and temperature. Tab. 4
containing several factors to multiply the maximum vacuum level according to the
conditions in the place of measurement can be used for reference.
Tab. 4: Ambient conditions
3 AMBIENT CONDITIONS
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4 TECHNICAL DESCRIPTION OF THE DEVICE
The device consists of a standalone electric suction device, optional medical devices
and accessories.
This User’s Manual provides technical information about the device within the scope
sufficient for safe operation, with more detailed information being specified in the
service manual. The service manual is intended for the persons authorized by the
manufacturer to service the device and is available upon request from the manufacturer
CHEIRÓN a.s. The diagrams, parts lists, descriptions, calibration instructions and other
information needed for service support and for repairs of such device parts determined
by the manufacturer as reparable are available from the device manufacturer upon
request.
The device can be used in those premises where it can be connected to
a 100–241 VAC network. The device is equipped with a detachable power supply
cable.
The individual assembly variants of the device are quite identical in terms of electrical
connection and structure, and they only differ in the vacuum output and the accessories
supplied, i.e. the purpose of application.
The device neither contains nor is controlled by any additional software. The device is
supplied in a non-sterile state.
During normal operation, device temperature will not exceed 48 °C.
Warning
The vacuum pump of the device is fitted with a thermal fuse to switch off the vacuum
pump if the device gets overheated. In such a case, switch off the device by operating
the main switch, disconnect the supply cable from the power socket and wait for at
least 30 minutes. Before resuming operation, check the suction and interconnection
tubes for not being obstructed.
• The device is classified per Council Directive 93/42/EEC, Annex IX, Rule 11 as
an active medical device of Class IIa.
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4.2 Electrical part
The device comprises an oil-free electric membrane vacuum pump with a thermal fuse,
a cooling system and electric circuitry. The device is connected to power supply to the
three-pin appliance inlet with a detachable power cord terminated with a three-pin
mains connector.
Warning
The device should only be connected to a power socket with a grounding
element. The electric shock protection category is Class I (earth conductor
protection).
4.2.1 Fuses
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4.3.1 Vacuum setting
Set the required vacuum value (suction force) by turning the vacuum control knob (Fig.
1, Pos. 10). Turn the knob clockwise to increase and counter-clockwise to decrease
the vacuum value.
Monitor the vacuum gauge of the device when turning the vacuum control knob (Fig.
1, Pos. 7). The vacuum indicator should turn continuously. If the vacuum indicator
movement is jerky or if it does not move at all, inform the competent service provider.
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5 SYMBOLS AND THEIR EXPLANATION
Identification of
Type B medical device
conformity with the
Notified Body number
IP code
Catalogue number IP 32
Reference to instructions
F1-F2 Fusible cut-out
in the user’s manual
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6 ABBREVIATIONS AND TERMS USED ON THE DEVICE
Warning
Alerts the operator to a potential hazardous situation which could result in a serious
personal injury or death.
Caution
Alerts the operator to a potential hazardous situation which could result in a minor or
medium serious personal injury.
7.1 Warnings
7.1.1 The device is not intended for environments with a risk of explosion.
7.1.2 Do not use flammable agents to clean the device.
7.1.3 Never use suction jars which are damaged in any way or not intended by the
manufacturer for the purpose as there is a risk of implosion.
7.1.4 Do not use the device in oxygen-enriched environments as there is a risk of
explosion.
7.1.5 For thoracic drainage, the suction jar and the limiting water valve must always be
located in a lower position than the patient.
7.1.6 Only use a collection jar with a screw closure for thoracic drainage.
7.1.7 The device is not approved for outdoor use or transport applications.
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7.1.8 Use the limiting water valve and other medical devices and accessories in strict
compliance with the operating instructions to secure patient’s safety.
7.1.9 If the limiting water valve is used, the opening of the inner tube on the top part of
the limiting water valve (intended for vacuum level setting) must be open during
the whole time of operation for free flow. This tube opening must never be closed.
Closing the tube opening could cause a serious damage to the patient.
7.1.10 Never use the device near the MRI equipment.
7.1.11 No maintenance works may be performed on the device or any of its parts when
used to treat a patient.
7.1.12 The cables and suction tubes which are parts of the device must not be routed
so as to pose a risk of strangling or suffocation of persons or pets.
7.1.13 An improper use of the device may damage the patient, operator, or property.
7.1.14 Only use the accessories specified or recommended by the manufacturer.
7.1.15 A substitute device should be available at all times for patients where any fault of
the device could cause a critical situation.
7.1.16 Do not immerse the device in water or rinse it under running water.
7.1.17 No modifications of the device are allowed. Never disassemble the device.
7.1.18 Do not change the setting of the device and its accessories. Always follow the
user’s manual.
7.1.19 It is forbidden to remove the suction jar holders which are attached to the device.
They may only be dismantled by trained professionals in compliance with the
instructions issued by the manufacturer.
7.1.20 Unplug the device from power supply before performing any kind of cleaning or
other handling works not related to the clinical operation.
7.1.21 The manufacturer specifies a microbiological suction filter (MSF) to be used to
prevent infection propagation from the suction jars.
7.1.22 The filter must be replaced at regular intervals (not later than 24 hours after being
put in the external suction circuit). The simplest, safest and comprehensive
solution is using disposable secret bags FLOVAC which already include
microbiological filters.
7.1.23 Handle the suction jars carefully to avoid any contamination of the environment.
7.1.24 Never pour disinfectants (persteril, chlorinated lime, etc.) into the suction jars to
decontaminate the infectious liquid during suction. The action of disinfectant
vapours may damage the device materials with subsequent cracking of the
suction jars or damaging other parts of the device.
7.1.25 Never place the device so as to make it difficult to disconnect the power cord
from the power socket.
7.1.26 The mobile variants of the device should always be used with all castor wheels
locked to avoid inadvertent disconnection of the plug from the power socket.
Prevent the portable variant of the device from spontaneous shifting over the
surface on which the device is installed.
7.1.27 The device must be connected to a power socket equipped with a protective
conductor to avoid electric shock.
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7.1.28 The vacuum pump of the device is fitted with a thermal fuse to switch off the
vacuum pump if the device gets overheated. In such a case, switch off the
device by operating the main switch, disconnect the supply cable from the power
socket, and wait for at least 30 minutes. Before resuming operation, check the
suction and interconnection tubes for not being obstructed.
7.1.29 During permanent suction operation with operator’s absence, the patient being
treated must be connected to another medical device to monitor his or her
current status. The specified accessory – the limiting water valve – must be used
for permanent suction operation.
7.1.30 Be sure to route the supply cable out of the hot surfaces.
7.1.31 No risk occurs if the patient or the operator is exposed to the device for a period
from 1 to 59 seconds. If the operator needs a longer period of time for contact
with the device or any of its parts, the device must be switched off.
7.1.32 The device operator is required to monitor the level of the suction jar during
suction. The suction jars designed to collect liquids during suction are
transparent to facilitate monitoring the liquid and foam levels. Any undesirable
liquid foaming in the suction jar can cause malfunction of the over-suction
protection mechanism.
7.2 Cautions
7.2.1 Check to make sure that all the suction system parts are connected properly to
avoid vacuum level decrease.
7.2.2 Do not use the sterile accessories if the sterile packaging is damaged.
7.2.3 The device is not intended to get into contact with the patient.
7.2.4 When using two suction jars simultaneously with both jars being interconnected,
please remove the overfilling prevention mechanism from the second jar (the
one to which the suction tube is connected).
7.2.5 Never remove the plug from the power socket by pulling by the mains cable.
7.2.6 Never leave the turned-on device unattended.
7.2.7 Please contact the manufacturer or its authorized dealer for assistance with the
operation of the device.
7.2.8 When mounting the device onto a mobile stand (Versa, Thorax, Lipos and
Economy models), it is only allowed to use the connecting parts set and supplied
by the manufacturer.
7.2.9 The device does not differentiate between use on adults or children. The method
of use in respect of the condition of paediatric patients is fully in competence of
the device operator.
7.2.10 If a liquid or some solid particles get into the device, contact the authorized
service or CHEIRÓN a.s. immediately. Making an early service intervention can
prevent the occurrence of a more serious damage.
7.2.11 If no suction circuit is connected to the device, make sure that no foreign objects
or dirt get into the device through the suction circuit connection port.
7.2.12 The device includes a suction tube which must never get into contact with the
treated part of the patient’s body. Always use a sterile suction catheter to prevent
infection occurrence.
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7.2.13 The Victoria Economy model as a limited possibility of connection of
accessories to the mobile stand.
7.2.14 Using additional equipment attached to the suction circuit may reduce the
suction power.
7.2.15 The device is intended for use up to max. altitude of 2000 m.
7.2.16 If the device gets stained by a biological material such as blood, make sure to
sterilize it with a virucidal agent.
7.2.17 Do not immerse the suction jars into disinfection solutions.
7.2.18 Never rinse the suction tubes by using them to transfer disinfection solutions
into suction jars. The flow of aggressive vapours would damage the other parts
of the device.
7.2.19 Before sterilization, all sterilizable parts must be treated according to the
applicable regulations.
7.2.20 Do not use the sterile equipment if its sterile packaging has been damaged.
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8 DESCRIPTION
8.1 Introduction
The electric suction device Victoria series are intended to be used predominantly in
operating theatres, hospital wards, and ICU.
The oil-free membrane vacuum pump guarantees achieving a high suction power and
does not require any maintenance. The device advantages consist in easy operation,
wide range of usability, and effortless handling and subsequent cleaning. The device
features a very silent run thanks to the use of a unique noise and vibration dampening
system.
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8.3 Indications
The device is intended for suction during both permanent and occasional use.
The device is intended for both male and female patients with no age limitations.
8.4 Contraindications
There are no contraindications known.
Caution
The doctor is responsible for assessing patient’s condition compatibility with the
surgical interventions and treatment procedures. The doctor must always evaluate and
choose the most appropriate treatment procedure based on his/her knowledge and
experience.
Caution
• When transporting the device (all variants) on the mobile stand and when
carrying it in hands, the suction jars must be empty.
• After transporting the device mounted on the mobile stand, always make sure
to lock the castor wheels of the mobile stand.
• When transporting the Victoria Thorax, Lipos and Versa models, pull them by
the handle in the rear part of the device in the direction of the handle.
• When transporting the Victoria Portable model, hold it by the handle on the top
and move to the required place (one person can handle the whole device).
• When transporting the Victoria Economy model, hold it in both hands and carry
it to the required place (one person can handle the whole device).
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9 VIEWS OF THE DEVICE
10
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15 16 17
11 12 13 14
Fig. 2: Electric suction device Victoria. rear part Fig. 3:Electric suction device Victoria - side part
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18 19 20 21 22 23 24 25 26 27
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(*) Note
The holder of the Victoria Thorax, Versa and Lipos models is located on the rear side
of the device casing.
The holder of the Victoria Portable model is located on the top of the device
casing.
The Victoria Economy model is not equipped with any holder on the device
casing.
(**) Note
The graphic sign above the control knob shows the suction power control direction, but
it is not a scale of adjustable values. The suction power increase or decrease result
can only be seen on the vacuum gauge of the device.
(*) Note
The Victoria Thorax model is equipped with a different over-suction jar, which
contains an element to connect a limiting water valve.
(**) Note
The Victoria Economy model is not equipped with a VD holder to attach the suction jar
and with VD holder plugs. The suction jar attachment holders are located on the front
part of the Economy mobile stand.
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9.2.1 Suction jar with cover
1) Float basket
2) Over-suction prevention float
3) Guiding tube
4) Cover inlet – VACUUM
5) Cover inlet – PATIENT
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9.2.2 FLOVAC disposable bag
Note:
The external suction circuit of the device consists of a set of individual medical
devices making up a system.
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9.2.4 Suction filter MSF
Warning:
• The Suction filter MSF is designed as disposable.
• The Suction filter MSF is intended for single patient treatment. Before
starting the treatment of another patient, the Suction filter MSF must be
replaced.
• Reused filter may cause infection ingress. Do not reuse the filter!
• The maximum usability period of the Suction filter MSF is 24 hours of
installing it in the external suction circuit.
• Never use the Suction filter MSF if damaged.
Caution
• Dispose of the Suction filter MSF after use according to the applicable hygiene
regulations.
• The Suction filter MSF is not intended to be cleaned.
• The Suction filter MSF replacement sticker is located on the device
top near the filter attachment port (Fig. 3, Pos. 16).
Note:
There is no need to attach the Suction filter MSF to the suction circuit if the
disposable FLOVAC or MONOKIT secretion bag is used.
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9.2.5 Stop valve disposable
1) Valve nozzle
2) Control orifice
3) Valve rear end Fig. 10: Stop valve
Connect the suction tube end to the rear end of the stop valve (Fig. 10, Pos. 3) (instead
of a suction interrupter). Connect suction catheters to the stop valve nozzle (Fig. 10,
Pos. 1). If the control orifice of the stop valve body (Fig. 10, Pos. 2) is not closed with
finger, no suction occurs. On the other hand, if the control orifice is closed with finger,
a dynamic suction process will start under the vacuum created previously in the entire
system.
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9.3.1 Twin limiting water valve with safety check valve
Thanks to the Victoria Thorax model design, one can use the maximum
device output while performing thoracic drainage simultaneously.
Warning
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9.3.1.2 Limiting water valve description
Fill the limiting water valve outer tube (2) with water up to approx. 2/3 of the max.
capacity (according to the required vacuum level) as follows: Pull out the inner
tube for vacuum level setting (4) and secure it with the lock nut (6). Then,
unscrew the outer tube counter-clockwise, fill it with water, screw it back and
tighten carefully (be sure not to damage the thread). Release the lock nut and
push the inner tube back into the outer tube. Set the required vacuum value in
cmH2O (see the formula in Chap. 9.3.1.3) by adjusting the inner tube immersion
depth. Secure the final position of the inner tube with the lock nut to prevent
leakage or a spontaneous movement of the inner tube. Fill the safety check valve
tube (1) with water so that after screwing in (the same procedure as above) the
inner tube is immersed 3–5 cm under the water level.
Note:
9.2.6 The safety check valve (1) of the limiting water valve puts up
resistance to the suction flow in dependence on the tube immersion
depth (cmH2O), whereby reducing the vacuum level set by the inner
tube (4) in the limiting water valve outer tube (2). Therefore, one has to
compensate for such vacuum loss (to immerse the vacuum setting
inner tube deeper) to obtain the required vacuum level for the patient.
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9.3.1.3 Vacuum level setting on the limiting water valve
To set the required vacuum level, submerge the inner tube (4) under the water level in
the outer tube (2). By changing the immersion depth, you can set the required vacuum
level (see the formula below). Secure the final position of the inner tube with the nut (6)
to prevent leakage or a spontaneous movement of the inner tube.
Example:
If the vacuum level required for a patient is 20 cmH2O and if the tube of the
safety check valve (1) is immersed 5 cm under the water level, the system output
is reduced by this value. Therefore, immerse the inner tube (4) to 25 cmH2O.
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9.3.2 Foot switch
The pneumatic foot switch is intended to switch the device off and on during aspiration.
It can also be used at the operator’s workstation located at a greater distance – approx.
2 m – from the device. Before using the foot switch, the device must be turned on by
means of the main switch.
Caution
After finishing the activity, with the vacuum pump still
running, switch the device off with the main switch. If
the device is switched off by means of the foot switch
and the foot switch it then disconnected, the vacuum
pump would not work when switching the device on
next time by means of the main switch despite the main
switch indicator being illuminated in green.
Fig. 13: Foot switch
Note
The request to include this element in the system must be specified when ordering the
device. Later on, the element can only be installed in the manufacturer’s plant.
The holder is supplied in variants for 0.5 l, 1 l, 2 l suction jars. The holder is to
be attached on the device side in the selected VD holder. After that, the
appropriate suction jar is placed into the suction jar holder.
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9.3.5 Catheter storage container
The store basket II is easily removable from the rear side of the
mobile stand. It is designed to keep not contaminated
consumables. The store basket II can be installed to the mobile
stand additionally without having to make any further
modifications.
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9.3.8 Suction circuit holder
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10 THE DEVICE CONFIGURATIONS
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10.3 Victoria Lipos
10.3.1 Device specification:
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10.5 Victoria Thorax
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11 DEVICE PREPARATION FOR USE
BE SURE TO MAKE A FUNCTION TEST BEFORE PUTTING THE UNIT INTO FULL
OPERATION
• Please check the supplied device for completeness and overall condition.
• Before using the device, please check first the power supply cable for not
being damaged and the device itself for not showing any defects
regarding safety.
• Before using the device, please check the parts of the external suction
circuit for not being damaged.
Caution
• Before putting the device into full operation, the user is required to
familiarize with and follow the instructions provided in the user’s
manual.
• The manufacturer recommends making regular safety & technical
inspections of the every 12 months with inspection reports being
issued.
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Note:
If the device does not reach the required vacuum level, the external or the internal
suction circuit may be leaking. In such a case, perform the Leak test of device parts
as described in Chap. 11.6 Leak Test.
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11.5 Starting up and disconnecting the device
To switch on the device, connect the detachable power supply cable to the socket on
the rear side of the device (Fig. 2, Pos. 11) and connect the other end of the power
supply cable with the mains plug in a fixed mains socket to provide a power source.
Start up the device by turning on the main switch on the front side of the device to the
ON position (Fig. 1, Pos. 9).
To stop the device, press the main switch to the OFF position. The main switch cannot
be used as the principal element for disconnecting the device. To disconnect the device
completely from the power source, disconnect the power supply cable from the fixed
mains socket by holding it by the plug. Never pull out the power supply cable by holding
it by the cable. Keep the device positioned so as not to prevent its disconnection from
the mains.
Disconnect the external suction circuit, i.e. the interconnecting tube (Fig. 4, Pos. 23)
including the connected suction filter MSF (Fig. 4, Pos. 21) from the over-suction jar
cover connector (Fig. 1, Pos. 8). Seal the free over-suction jar cover connector with
your finger. Turn the vacuum control knob (Fig. 1, Pos. 10) clockwise to increase the
suction power to the maximum.
If the device responds by increasing the suction power and if the vacuum gauge (Fig.
1, Pos. 7) also shows the increase to the maximum vacuum value (−92 ± 5) kPa, the
internal suction circuit of the device is in order and the defect (leakage), if any, should
be searched for in the external suction circuit (outside the device). In such a case,
make a leak test of the external suction circuit (see below).
Assemble the device according to the instructions provided in Chap. 11.3 External
suction circuit assembly. Seal the end of the suction tube (Fig. 4, Pos. 24), turn the
vacuum control knob (Fig. 1, Pos. 10) to set the suction power to the maximum and
monitor the continuous vacuum increase on the vacuum gauge of the device (Fig. 1,
Pos. 7).
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Leak test conclusion:
If the device passes the leak test according to Chap. 11.6.1 but fails the leak test
according to Chap. 11.6.2, the leakage is in the external parts of the system.
If the device fails the leak test according to Chap. 11.6.1, the leakage is in the internal
parts of the suction circuit.
Caution
Be sure to check the correct interconnection of the individual parts of the
suction system to avoid any decrease in the vacuum level.
12 TROUBLESHOOTING
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13 CLEANING AND MAINTENANCE
13.1 General
Warning
All the device parts contaminated during aspiration must cleaned, disinfected,
sterilized or disposed of after every use of the device. Before cleaning, always
disconnect the device from the power socket.
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Disassembly
Dismantle all removable parts before cleaning, disinfection or sterilization.
Warning
Never immerse the device in water or other liquid.
Never use abrasive substances, alcohol or solvents to clean the device as
they may damage the plastic parts or remove the stickers.
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Caution
Always contact the manufacturer of suction devices CHEIRÓN a.s. for approval
of application of other disinfectant than that specified above.
Warning
• Never use colour disinfectants (such as Betadine) which could etch and
impair the transparency of the plastic material of the jar.
• Never use combustible materials to clean the device.
• If the device gets stained by a biological material, such as blood, disinfect
it with a virucide product.
• Never rinse the suction tubes by using them to transfer disinfection
solutions into suction jars. The flow of aggressive vapours would damage
the other parts of the device.
Never pour disinfectants (persteril, chlorinated lime, etc.) into the suction
jars to decontaminate the infectious liquid during suction. The action of
disinfectant vapours may damage the device materials with subsequent
cracking of the suction jars or damaging other parts of the device or
accessories.
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14 WARRANTY AND POST-WARRANTY SERVICE
The warranty period of the vacuum pump of the electric suction device Victoria,
Portable, Versa, Thorax and Lipos models, is 6 years, and the warranty period of the
other parts is 1 year. If the sale of the product is governed by the Civil Code, the warranty
period of the device is 2 years. The warranty and post-warranty services are provided
by CHEIRÓN a.s. or its authorized service organizations.
Caution
• If liquids or solid particles penetrate into the device, contact the authorized
service or CHEIRÓN a.s. immediately. Making a timely service intervention
will prevent greater losses from occurring.
• The expected service life of the Victoria device is set by the manufacturer
to be 10 years. The user can influence the above-mentioned period
considerably by using and maintaining the device appropriately.
Note:
Defective materials will be replaced during the warranty period free of charge on the
precondition that the defect has not been caused by improper or wrong use. This
provision does not relate to the parts subject to regular wear and tear.
15 RECYCLING
The electric waste includes electric appliances and their parts and electrical
and electronic components. It must be separated from the municipal and
mixed waste and has different rules stipulated for collection, disposal and
handling. The device must not be disposed of together with unsorted
municipal waste.
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16 PRODUCT NAMES AND ORDERING NUMBERS
Collection jar type MAK 2000 ml complete, screw lid, 000-030-000 Flow-Meter S.p.A.
Polycarbonate
Collection jar type MAK 2000, complete, screw lid, 000-030-050 Flow-Meter S.p.A.
Polysulfone
Collection jar type MAK 2000ml, pressure lid, with 000-030-130 Flow-Meter S.p.A.
CHEIRÓN logo, Polycarbonate
Collection jar type MAK 4000 complete, press on lid, 000-100-000 Flow-Meter S.p.A.
Polycarbonate
Collection jar type MAK 4000ml, complete, press on 000-100-010 Flow-Meter S.p.A.
lid, Polysulphone
Reusable canister FLOVAC 2 L 970-010-212 Flow-Meter S.p.A.
Canister FLOVAC 2,0 L with 1,8 m hose and vacuum 000-036-041 Flow-Meter S.p.A.
breaker
Disposable Liner type Monokit with hydrophobic filter 000-035-020 Flow-Meter S.p.A.
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Description Ordering Manufacturer
number
Liner FLOVAC 2,0 L with 1,8 m hose 000-036-031 Flow-Meter S.p.A.
Liner FLOVAC 2,0 L with 1,8 m tube and vacuum 000-036-051 Flow-Meter S.p.A.
breaker
Limiting water valve, double 11-5106 Flow-Meter S.p.A.
Suction tube - PVC hose 12x8mm, 20m roll 524-000-0094 Pacific Hospital Supply
Co.Ltd.
Hose 8 x14 mm, silicone 232-008-014 DICOINSA, S.L.
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16.3 Optional device accessories
Tab. 9: Optional device accessories
Description Ordering Manufacturer
number
Suction circuit Victoria Lipos, Versa - PVC 11-5133 CHEIRÓN a.s.
Suction circuit Victoria Lipos, Versa - silicone 11-5134 CHEIRÓN a.s.
Suction circuit Victoria Portable - PVC 11-5135 CHEIRÓN a.s.
Suction circuit Victoria Portable - silicone 11-5136 CHEIRÓN a.s.
Suction circuit Victoria Thorax - silicone 11-5137 CHEIRÓN a.s.
Suction circuit Victoria - Economy 11-5146 CHEIRÓN a.s.
Suction circuit PVC with stop valve 305-999-002 CHEIRÓN a.s.
Silicone suction tubing with stop valve 1,5m 305-999-001 CHEIRÓN a.s.
Mobile stand Victoria 11-5104 CHEIRÓN a.s.
Support ring for MAK 1l, plastic 11-5142 CHEIRÓN a.s.
Plastic ring for jar MAK 1000 ml 920-200-421 Flow-Meter S.p.A.
Plastic Ring for Jar MAK 2000 ml 920-200-422 Flow-Meter S.p.A.
Support ring for Flovac for 1, 2 L 11-5144 CHEIRÓN a.s.
Holder for suction jar 4 l, eurorail 11-5109 CHEIRÓN a.s.
Holder for 4 l jar, eurorail - double 11-5114 CHEIRÓN a.s.
Support ring for FLOVAC container with 25x5 slide 970-010-210 Flow-Meter S.p.A.
Plastic rail bracket for jars 000-230-500 Flow-Meter S.p.A.
Catheter container 1000 ml 0-80-0030 CHEIRÓN a.s.
Holder for catheter container 1000 ml 11-5126 CHEIRÓN a.s.
Holder for suction circuit Victoria 11-5110 CHEIRÓN a.s.
Foot switch 114-047-000 CHEIRÓN a.s.
Foot switch - toggle switch variant 114-047-000/1 CHEIRÓN a.s.
Change over valve for eurorail - Basic 11-5131 CHEIRÓN a.s.
Rear basket II 11-5105 CHEIRÓN a.s.
Shelf 11-5116 CHEIRÓN a.s.
(*) To be specified when ordering. Can only be installed additionally in the manufacturer’s plant.
Note:
Other additional information concerning the accessories and spare parts can be
obtained from the manufacturer CHEIRÓN a.s. or its distributors.
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17 EMC
17.1 Emissions
Tab. 10: EMISSION Limits for the Environment
Phenomenon Environment of professional medical devices (a)
RF EMISSIONS conducted
CISPR 11
and radiated
Harmonic distortion See IEC 61000-3-2 (b)
Voltage fluctuation and flicker See IEC 61000-3-3 (b)
a) See 8.9 for information concerning the INTENDED USE environment.
b) This test is not applicable in this environment if the ME EQUIPMENT and ME
SYSTEMS used are connected to a PUBLIC POWER SUPPLY NETWORK and the
power supply is otherwise within the scope of validity of the general EMC standard.
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Tab. 12: Entry/Exit through AC Power Supply
Fundamental Environment of professional
Phenomenon
EMC standard medical devices
Electrical fast transients / ±2 kV
IEC 61000-4-4 Repetition frequency 100 kHz
bursts (a) (l)
Surge (a) (b) (j) (o) IEC 61000-4-5 ±0.5 kV, ±1 kV
Surge (a) (b) (j) (k) (o) between ±0.5 kV, ±1 kV, ±2 kV
IEC 61000-4-5
phase and earth
3 V (m) 0.15 MHz to 80 MHz
6 V (m) in ISM bands
Conducted disturbances induced
IEC 61000-4-6 between 0.15 MHz and 80 MHz (n)
by RF fields (c) (d) (o)
80 % AM at 1 kHz
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Tab. 13: Specification of IMMUNITY Test against ENTRY/EXIT THROUGH DEVICE
HOUSING from RF Wireless Communication Instruments
Immunity
Testing
Banda) a) b) Maximum Distance testing
frequency Service Modulation level
(MHz) power (W) (m)
(MHz) (Vm)
Pulse
385 380 to 390 TETRA 400 modulationb) 1.8 0.3 27
18 Hz
FMc) ±
deviation 5
GMRS 460, kHz
450 430 to 470 2 0.3 28
FRS 460 1 kHz
sinus curve
710 Pulse
LTE band
745 704 to 787 modulationb) 0.2 0.3 9
13, 17 217 Hz
780
GSM
810 800/900,
TETRA
Pulse
800, iDEN
870 800 to 960 modulationb) 2 0.3 28
820, CDMA
18 Hz
850,
930 LTE band 5
GSM 1800;
1720 CDMA
1900; GSM
Pulse
1700 to 1900;
1845 modulationb) 2 0.3 28
1990 DECT; LTE
217 Hz
band 1, 3,
1970 4, 25;
UMTS
Bluetooth,
WLAN,
Pulse
2400 to 802.11
2450 modulationb) 2 0.3 28
2570 b/g/n, RFID
217 Hz
2450, LTE
band 7
5240 Pulse
5100 to WLAN
5500 modulationb) 0.2 0.3 9
5800 802.11 a/n
5785 217 Hz
NOTE: If necessary to reach the testing level, the distance between the transmitting antenna and the ME
equipment or ME system can be shortened to 1 m. IEC 61000-4-3 allows the testing distance to be 1 m.
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18 LIST OF REVISIONS
List of revisions
Version Version
Change description
valid since No.
11.03.2020 200311 First issue – drawn up in connection with Victoria device testing
on the basis of applicable standards.
CHEIRÓN a.s.
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