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Cheiron Victoria

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0% found this document useful (0 votes)
890 views50 pages

Cheiron Victoria

Uploaded by

Rudi Canicela
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

User’s Manual

Electric Suction Device

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.

LIST OF DEVICE MODELS


Tab. 1: The device models
Model Voltage REF Voltage REF
Victoria Portable 230 VAC 11-1112 120 VAC 11-1113
Victoria Versa 230 VAC 11-1122 120 VAC 11-1123
Victoria Thorax 230 VAC 11-1132 120 VAC 11-1133
Victoria Lipos 230 VAC 11-1142 120 VAC 11-1143
Victoria Economy 230 VAC 11-1152 120 VAC 11-1153

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2 TECHNICAL DATA

Tab. 2: Technical data for the device 230 V models

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

Nominal fuse value 2x T 2AL/250 V 2x T 2AL/250 V 2x T 2AL/250 V 2x T 2AL/250 V 2x T 2AL/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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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

Altitude / max. vacuum Sea level 1 000 m 2 000 m

Factor 1.00 0.88 0.78

3 AMBIENT CONDITIONS

3.1 Device operation ambient conditions


Ambient temperature: +10 °C to +35 °C
Relative humidity: 10 % to 75 % RH

3.2 Transport ambient conditions


The device should be transported using covered transportation means and protected
with an appropriate package against shocks during transport.
Ambient temperature: −5 °C to +60 °C
Relative humidity: 10 % to 75 % RH

3.3 Storage ambient conditions

The device should be stored in dry rooms.

Ambient temperature: −5 °C to +60 °C


Relative humidity: 10 % to 75 % RH

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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.

4.1 Device classification

• The device is classified per Council Directive 93/42/EEC, Annex IX, Rule 11 as
an active medical device of Class IIa.

• Class I electrical instrument with a protective conductor.

The device is a medical device featuring a measurement function. The


accuracy class of the measuring instrument (vacuum gauge) is 1.6 %.

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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

• Fuses used in the device, 230 VAC models:


Fuse T – slow 5 x 20 mm; 0.800 A / 250 V; L – low breaking capacity
Breaking capacity: 35 A
Fuse dimensions: 5 x 20 mm
Response speed: T – slow blowing
Rated current: 0.8 A
Rated voltage: 250 V

• Fuses used in the device, 120 VAC models:


Fuse T – slow 5 x 20 mm; 2A / 250 V; L – low breaking capacity
Breaking capacity: 35 A
Fuse dimensions: 5 x 20 mm
Response speed: T – slow blowing
Rated current: 2A
Rated voltage: 250 V

4.3 Pneumatic part


The pneumatic part of the device comprises an external suction circuit accessible to
the operator and an internal suction circuit inside the device, inaccessible to the
operator.
A mechanical vacuum regulator is located on the device control panel to control the
vacuum level monitored by means of a built-in vacuum gauge. The device also includes
a detachable over-suction jar.

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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.

Note:The vacuum gauge metering function is to be verified by the authorized service


provider during the scheduled professional maintenance.
The set vacuum value is only indicated by the vacuum gauge on the precondition that the
external suction circuit is closed, i.e. by kinking or pressing the interconnection tube with
fingers, for instance.

THE VICTORIA SUCTION PUMP MEETS THE REQUIREMENTS OF THE FOLLOWING


STANDARDS:
Tab. 5: List of applicable standards

Medical electrical equipment – Part 1: General


ČSN EN 60601-1
requirements for safety
Medical electrical equipment – Part 1: General
requirements for safety – Collateral standard:
ČSN EN 60601-1-1 ed. 2
Safety requirements for medical electrical systems

Medical electrical equipment – Part 1: General


ČSN EN 60601-1 ed. 2 requirements for basic safety and essential
performance

Medical electrical equipment – Part 1-2: General


requirements for basic safety and essential
ČSN EN 60601-1-2 ed. 3 performance – Collateral standard:
Electromagnetic interference – Requirements and
tests
ČSN EN ISO 10079-1 ed. 2 Medical suction equipment – Part 1: Electrically
powered suction equipment
Medical devices - Application of risk management
ČSN EN ISO 14971
to medical devices
Act No. 89/2021 Sb. Medical Devices Act

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5 SYMBOLS AND THEIR EXPLANATION

Tab. 6: List of symbols

Class I electric device


Warning
with protective conductor

Caution Electric waste

Identification of
Type B medical device
conformity with the
Notified Body number

Alternating current Serial number

Do not reuse (only applies


Date of manufacture
to the MSF filter)

Manufacturer Temperature limitation

Latex free Lot number

IP code
Catalogue number IP 32

Use by date AC Alternating current

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

Device Electric suction device Victoria


Vacuum Pressure lower than the atmospheric one
Main switch Changeover-type switch to switch the device on and off. Press the
upper half of the switch to switch on the device. Device operation
is signalled by the switch illuminated in green. Press the lower half
of the switch to switch off the device and the green light.
Min/Max Lowest/highest suction power when setting vacuum
Suction Using vacuum to remove liquids, solid particles or gases from
patients

7 WARNINGS, CAUTIONS AND SAFETY INSTRUCTIONS

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.

7.3 General Instructions


7.3.1 Do not use the device without first reading the user’s manual carefully and
understanding the contents and instructions provided herein.
7.3.2 Always keep the operating instructions attached to the medical devices supplied
with this device together with this user’s manual for future reference.
7.3.3 The device operator must not be the patient at the same time. One person
operates the device, while the other is the patient.
7.3.4 Do not use the device after having found any visible damage to the device
casing, to the optional medical devices or power cord.
7.3.5 Do not use the device without making sure first that it is complete and that all its
functions are correct.
7.3.6 Do not use the device if it is damaged or cannot be set up. In such a case, ensure
device inspection and/or repair immediately.
7.3.7 Do not replace the fuses in the device. Fuse may only be replaced by an
appropriately qualified person.
7.3.8 Always have the device positioned so as not to prevent disconnection from the
mains.
7.3.9 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.

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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.

8.2 Basic information on the device


The vacuum source of the device is an oil-free membrane vacuum pump which ensures
a high suction power and does not require any maintenance by the user. The vacuum
regulator is used to control vacuum ranging from −7 kPa to −92 kPa. The current
vacuum value is monitored by the vacuum gauge of the device.
High flexibility is provided by a Euro-rail which can hold collection jars of different
capacities (0.5 l, 1 l, 2 l, 4 l) as well as other optional accessories and medical devices
(limiting water valve, suction circuit holder, etc.).
The device comes with 2 l polycarbonate or polysulphone suction jars or with 4 l
polycarbonate suction jars. The 2 l polycarbonate suction jar can be used together with
the MONOKIT or FLOVAC disposable secretion bags. All suction jars are equipped
with an overfill control system. The manufacturer specifies a microbiological suction
filter (MSF) to be used to prevent infection propagation from the suction jars.
The device can be equipped additionally with a pneumatic foot switch to facilitate
handling and control during the suction operation (*).
The front panel of the device is provided with information (symbols) for the operator.
The rear part of the device bears a rating plate showing the manufacturer’s
identification data, the technical data, and symbols for the user.
The device neither contains nor is controlled by any additional software.
The device has been designed for operation by a single person.
(*) 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.

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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.

8.5 Authorized users


The device may only be operated by qualified staff or persons who have familiarized
themselves thoroughly with and understood the instructions provided in this User’s
Manual. Before commissioning the device, the user is required to familiarize with and
follow the instructions provided in this User’s Manual.

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.

8.6 Handling the device


The Victoria series devices are portable and designed to be transported from one
place to another. If in the PORTABLE version (without being mobile), the device is
equipped with a wide handle on the top to be transported by a single person. Upon
request, the manufacturer can supply the device in a mobile variant, with the device
structure being modified and attached (in a removable manner) to a mobile stand with
lockable castor wheels (see Chap. 9.3 Optional Accessories Available for device).
If the device is mounted on the stand, move it by the handle.

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

Fig. 1: Electric suction device Victoria

1) VACUUM inlet on the suction jar


2) FROM PATIENT port on the suction jar
3) Suction jar cover
4) Suction jar holder
5) Device holder (*)
6) Foots – 4 pcs
7) Vacuum gauge
8) Over-suction prevention jar port
9) Mains switch
10) Vacuum control knob (**)

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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

11) IEC socket to connect the power cord


12) Self-adhesive rating plate
13) Device holder (*)
14) Fuse compartment 2 pcs
15) Over-suction prevention jar (***)
16) Self-adhesive filter replacement sticker
17) VD holder with a hook

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18 19 20 21 22 23 24 25 26 27

Fig. 4: Electric suction device Victoria Thorax

18) Victoria II suction device casing 23) Interconnecting tube (to


interconnect 2 suction jars)
19) Twin limiting water valve with a safety 24) PVC (silicone) suction tube 1.5 m
check valve

20) Euro-rail of Victoria II stand 25) Store basket II


21) Suction filter MSF 26) Mobile stand Victoria II
22) Interconnecting tube (to interconnect the 27) Stop valve (optional)
device and the suction jars)

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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.

9.1 Contents of standard Victoria device delivery

• Suction device Victoria (Thorax, Lipos, Versa, Portable or Economy models)


• Over-suction jar (*)
• Complete PVC (silicone) external suction circuit
• Detachable mains supply cable
• VD holder plugs (**)

(*) 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.

The recommended basic assembly of the Victoria series devices is


described in Chapter 10 Victoria device assembly.

9.2 Medical devices (MD) available for Victoria device

• Suction jars with covers (variants)


• FLOVAC disposable bag
• Complete PVC (silicone) external suction circuit – standard part of the delivery
- Stop valve
- Suction tube
- Interconnecting tube
- Suction filter MSF

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9.2.1 Suction jar with cover

Shock-resistant, sterilizable to the manufacturer’s


instructions provided in the user’s manual.
Suction jar variants:

Suction jar 0.5 l, screw cover


Suction jar 1 l, screw cover
Suction jar 2 l, polycarbonate
Suction jar 2 l, polysulphone
Suction jar 2 l, press-in cover
Suction jar 2 l, screw cover
Suction jar 4 l, press-in cover

Fig. 5: Suction jar

9.2.1.1 Suction jar cover


The suction jar cover is attached to the jar by means of a thread. Remove the cover by
turning it counter-clockwise. Never try to remove the cover by force to avoid damaging
the threads.
1 2 3 4 5

1) Float basket
2) Over-suction prevention float
3) Guiding tube
4) Cover inlet – VACUUM
5) Cover inlet – PATIENT

Fig. 6: Suction jar cover

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9.2.2 FLOVAC disposable bag

The FLOVAC disposable bag makes it possible to dispose of the


content without having to replace the suction jar. The FLOVAC bag
is disposable. It comprises a bag to which a cover is attached in a
non- detachable manner. The FLOVAC bag cover contains a
hydrophobic bacterial filter which treats the contaminated air
passing through and serves as an overfilling prevention
mechanism. It prevents liquid over-suction to the unit and
consequent contamination of the whole system. After filling the
bag with liquid, close both (outlet/inlet) holes in the FLOVAC cover
to prevent spilling.

Fig. 7: FLOVAC disposable bag

9.2.3 Complete PVC (Silicone) external suction circuit

Note:
The external suction circuit of the device consists of a set of individual medical
devices making up a system.

9.2.3.1 1.5 m PVC suction tube


The suction tube of 1.5 m in length comes
with a stop valve. It forms a part of the
external suction circuit between the suction
jar and the optional medical device used for
direct contact with the patient. The PVC
suction tubes are designed as disposable. Fig. 8: PVC Suction Hose
Size: inner diameter: 8 mm, outer diameter: 12 mm
The disposable PVC suction tube can be replaced with a reusable silicone tube
supplied as ordered.
9.2.3.2 1.5 m Silicone suction tube
The suction tube of 1.5 m in length comes with a stop valve. It forms a part of the
external suction circuit between the suction jar and the optional medical device used
for direct contact with the patient. The silicone suction tubes are designed as reusable
after sterilization.
The silicone suction tube is an optional medical device supplied upon customer’s
request to replace the PVC suction tube.
Size: inner diameter: 8 mm, outer diameter: 14 mm

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9.2.4 Suction filter MSF

Always use the Suction filter MSF to connect the suction


circuit to the device. Connect the interconnecting tube to
the Suction filter MSF and push the other end of the suction
filter into the short silicone tube attached to the suction
circuit connector. The Suction filter MSF treats the
aspirated air before entering the device. Using the Suction
filter MSF prevents potential propagation of contaminated
air from the device into the ambient and protects the device
against over-suction. Please follow the Suction filter MSF
operating instructions when using the filter.

Fig. 9: 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

The stop valve is intended to facilitate the


control of the suction process. When operating
the stop valve, the operator is not in contact
with the aspirated liquid.

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.

9.3 Optional accessories available for Victoria devices

• Limiting water valve


• Foot switch
• Suction jar holder (not part of the Victoria Economy model)
• Suction jar changeover switch
• Catheter storage container
• Store basket
• Suction circuit holder
• Single or twin catheter storage container holder
• Suction jar holders for Euro-rail (various types) – plastic (according
to the suction jar chosen)
• Mobile stand Victoria
Note:
For a complete list of optional accessories designed for the Victoria device see
Chap. 16.3 Optional device accessories or the web pages of the manufacturer
CHEIRÓN a.s.

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9.3.1 Twin limiting water valve with safety check valve

9.3.1.1 Using the Limiting water valve


The twin limiting water valve is used with the Victoria THORAX model only to
secure
a safe thoracic suction process. The aim of the limiting water valve is to prevent
uncontrolled vacuum increase in the suction circuit which would result in damaging
the lungs (pneumothorax) and serious injury of the patient. The range of safe
vacuum levels is from approx..10 cmH2O to 40 cmH2O. The limiting water valve is
equipped with a safety check valve to prevent ambient air from entering the
patient’s thorax cavity in case of vacuum supply failure.

Thanks to the Victoria Thorax model design, one can use the maximum
device output while performing thoracic drainage simultaneously.

Fig. 11: Limiting water valve - connection

Warning

• To ensure patient’s safety, use the limiting water valve


exactly in accordance with the operator’s manual.
• When using the limiting water valve, the opening of the inner tube on the
top of the limiting water valve (used to set vacuum level) must be open
(free) during the whole operation period. This opening must never be
closed. Closing the opening can cause a serious damage to the patient.
• During thoracic drainage, the suction jar and the limiting water
valve must always be placed lower than the patient.
• The limiting water valve is to be installed in the suction circuit
between the suction jar and the over-suction jar.

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9.3.1.2 Limiting water valve description

1) Safety check valve


2) Limiting water valve outer tube
3) Outlet for suction jar connection
4) Inner tube for vacuum level setting
5) Outlet for vacuum supply connection
6) Lock nut
7) Through-flow valve

Fig. 12: 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.

Vacuum calculation formula: P=


X − Y P – Resultant vacuum level (cmH2O)
X – Immersion depth of the inner tube (4) to set vacuum (cm)
Y – Immersion depth of the inner tube of the safety check valve (cm)

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.

9.3.1.4 Limiting water valve leak test


Connect the interconnecting tube to the over-suction jar connector and the other end of
the interconnecting tube to the vacuum supply outlet connector (5) of the limiting water
valve. Switch on the device and set the vacuum regulator to MAX. Close the through-
flow valve (7) of the limiting water valve by turning it clockwise. Block the end of the
suction tube with your finger. Now, turn the through-flow valve slowly counter- clockwise.
If the whole suction system is leak-tight, the limiting water valve will start “bubbling” –
sucking in ambient air through the inner tube (4). Thus, the limiting water valve has been
tested and is ready for use. The vacuum level in the suction circuit cannot rise above the
vacuum value calculated using the resultant vacuum calculation formula (Chap. 9.3.1.3).
Reduce the “bubbling” intensity by means of the through-flow valve to approximately 3
bubbles per second.
The patient can be connected after making all the activities above.

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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.

9.3.3 Suction jar holder

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.

Fig. 14: Suction jar holder

9.3.4 Suction jar changeover switch

The suction jar changeover switch is used when using two


suction jars to treat a patient. The changeover switch
selects the one of the two suction jars to be used to collect
the just aspired liquid. In contrast with the standard
connection of suction jars in series with no changeover
switch, the connection with the changeover switch allows
replacing and cleaning the suction jars one by one.

Fig. 15: Suction jar changeover switch

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9.3.5 Catheter storage container

A polycarbonate cylinder of 40 cm in length is used to store


suction catheters.
The container is autoclavable and is to be attached to
a Euro-rail by means of a holder.
Optionally, a dual container holder can be ordered.

Fig. 16: Catheter storage container


9.3.6 Store basket II

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.

Fig. 17: Store basket


9.3.7 4 l Suction jar holder for euro-rail, single/twin

The 4 l suction jar holder is designed to


hold 4 l suction jars. Attach the holder to
the euro-rail and put a suction jar in it.

Fig. 18: 4 l Suction jar holder for euro-rail

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9.3.8 Suction circuit holder

The suction circuit holder is designed to facilitate affixing the


suction circuit. Attach the holder to the euro-rail and put the
suction circuit in it.

Fig. 19: Suction circuit holder


9.3.9 Catheter storage container holder, single/twin
The catheter storage container holder is designed to facilitate holding catheter containers.
Attach the holder to the euro-rail and put the catheter container in it.

9.3.10 Suction jar holder clamp – plastic

Attach the clamp to the euro-rail of the mobile stand and


put the suction jar holder in it (Fig. 14, Chap. 9.3.3).
The FLOVAC collection jar holder is designed to attach all
FLOVAC suction jar types. Attach the holder to the euro-
rail (on the mobile stand, for instance) and put a suction jar
in it.
Fig. 20: Suction jar holder clamp
Note:
The FLOVAC collection jar holder consists of the collection jar holder and FLOVAC
holder clamp - plastic. Specify both items when ordering.

9.3.11 Mobile stand Victoria II

The Victoria devices of VERSA, THORAX, LIPOS,


ECONOMY models are designed for mounting on
a mobile stand to increase device mobility and facilitate
handling. The mobile stand can be ordered additionally at
any time, and the device can be mounted on the mobile
stand easily. All Victoria series devices support the option of
additional mounting on the mobile stand (*).
An integrated catheter storage container can be installed on
the rear side of the mobile stand upon request. In such a
case, the store basket II cannot be mounted additionally on
and used with the device
Fig. 21: Mobile stand Victoria
(Fig. 17, Chap. 9.3.6).
(*) Note:
The Victoria ECONOMY model provides a limited possibility of attaching accessories
to the mobile stand.

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10 THE DEVICE CONFIGURATIONS

10.1 Victoria Portable

10.1.1 Device specification:


Powerful device intended especially for medical
establishments and hospital wards, suitable for both
quick short-term and long-term suction processes.
Suitable for building in endoscopic towers. The device
is equipped with a holder on the top to facilitate
transport.
Recommended configuration of this model:
• Victoria Portable (see Chap. 9.1 Contents of Fig. 22: Victoria Portable
standard Victoria device delivery)
• Suction jar holder (1 l, 2 l)
• Suction jar (1 l, 2 l), press-in cover
• Complete PVC (silicone) external suction circuit

10.2 Victoria Versa

10.2.1 Device specification:

Most favoured model with a wide range of application in hospital


wards, anaesthesiology departments, ICU, operating theatres,
internal medicine departments, ORL, surgery, gynaecology,
orthopaedics, endoscopy, etc.
Recommended configuration of this model:
• Victoria Versa (see Chap.
9.1 Contents of Standard Victoria device delivery)
• 2 l suction jar holder for Euro-rail
• 2 l suction jar, press-in cover
• Complete PVC (silicone) external suction circuit
• Mobile stand Victoria II (with an option of additional Fig. 23: Victoria Versa
customized equipment)

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10.3 Victoria Lipos
10.3.1 Device specification:

High suction power. The device is intended predominantly


for liposuction and operating theatres.
Recommended configuration of this model:
• Victoria Lipos (see Chap.
9.1 Contents of Standard Victoria device delivery)
• 2 l suction jar holder for Euro-rail
• 2 lsuction jar, press-in cover
• Complete PVC (silicone) external suction circuit
• Mobile stand Victoria II (with an option of additional
customized equipment)

Fig. 24: Victorai Lipos

10.4 Victoria Economy

10.4.1 Device specification:

Device designed for regular aspiration processes. Limited


range of device accessories with a different mobile stand
without the euro-rail.
Recommended configuration of this model:
• Victoria Economy (see Chap. 9.1 Contents of standard
Victoria device delivery)
• 1 l, 2 l suction jar holder
• 2 l suction jar, press-in cover
• Complete PVC (silicone) external suction circuit
• Mobile stand Economy (without Euro- rail, 2 suction jar
holders located on the front part of the stand) with an
option of additional customized equipment Fig. 25: Victoria Economy

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10.5 Victoria Thorax

10.5.1 Device specification:

Device designed for both regular aspiration and


drainage processes during intensive care, thorax and
abdominal surgery.
The device features a simple and unique way to enable
full-power aspiration even during drainage.

Recommended configuration of this model:


• Victoria Thorax (see Chap. 9.1 Contents of
standard Victoria device delivery)
• 2 L suction jar holder for Euro-rail, 2 pcs
• 2 L suction jar, screw cover, 2 pcs
• Complete PVC (silicone) external suction circuit Fig. 26: Victoria Thorax
• Mobile stand Victoria II (with an option of
additional customized equipment)
• Twin limiting water valve
• Interconnection tube between the over-suction jar and the limiting water valve

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11 DEVICE PREPARATION FOR USE

BE SURE TO MAKE A FUNCTION TEST BEFORE PUTTING THE UNIT INTO FULL
OPERATION

11.1 Instructions before putting the device into 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.

11.2 Function Test


Assemble the device according to Chap. 9 Views of the device. Choose the
recommended medical devices and accessories for the assembly.
Provide a suitable source of electrical energy and start up the device by
operating the main switch (Fig. 1, Pos. 9).
Set the required vacuum level:
Close the control opening of the stop valve with your finger (Fig. 10, Pos. 2) to
create vacuum, the level of which is then either increased or decreased by
turning the vacuum control knob (Fig. 1, Pos. 10). Turn the knob clockwise
(increase) or counter- clockwise (decrease) to obtain the required vacuum, the
current value of which is shown on the vacuum gauge of the device (Fig. 1, Pos.
7).

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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.

11.3 External Suction Circuit Assembly


Insert the over-suction jar (Fig. 3, Pos. 15) into the over-suction jar port on the device
side. Connect the suction filter MSF (Fig. 4, Pos. 21) to the over-suction jar connector
(Fig. 1, Pos. 8) by means of the short interconnecting tube. Connect the interconnecting
tube (Fig. 4, Pos. 22) to the other end of the suction filter MSF. Connect the other end
of the interconnecting tube to the VACUUM port on the suction jar cover (Fig. 1, Pos.
2).
Note:
There is no need to connect the suction filter MSF to the external suction circuit when
using the FLOVAC or MONOKIT secretion bag.

11.4 Interconnection of Two Suction Jars


Connect the suction tube (Fig. 4, Pos. 24) to the
PATIENT port on the suction jar cover (Fig. 1, Pos.
2). If two suction jars are used, interconnect them
in series as shown in Fig. 27. Connect the
interconnecting tube (Fig. 4, Pos. 23) routed from
the device to the VACUUM port on the suction jar
cover (Fig. 1, Pos. 1) of the first suction jar, and
connect the short interconnecting tube (supplied
by the manufacturer as a standard when ordering
this option) to the PATIENT port on the cover of
the first suction jar with the VACUUM port on the
cover of the second suction jar. Connect the
suction tube (Fig. 4, Pos. 24) to the PATIENT port
on the cover of the second suction jar. Fig. 27: Suction jar changeoverswitch

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11.5 Starting up and disconnecting the device

11.5.1 Switching the device on

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).

11.5.2 Switching the device off

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.

11.6 Leak Test


Make a leak test if the device does not achieve the declared suction output −92 ± 5 kPa.
The current values can be seen on the vacuum gauge of the device.

11.6.1 Leak Test – INTERNAL SUCTION CIRCUIT

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).

11.6.2 Leak Test – EXTERNAL SUCTION CIRCUIT

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

The device cannot be put into operation


• Check the device for being switched on.
• Check the mains voltage for being correct.
• Check the power supply cable plug for being connected properly to the mains
socket.
• The thermal fuse could have shut down the vacuum pump. Turn the main
switch off and wait 30 minutes before turning the device on again with the
main switch.

If the defect persists, contact the manufacturer or an authorized


service provider.
Insufficient vacuum
• Check the vacuum control knob for being in the correct position.
• Check the external and internal suction circuits for leak-tightness as described
in Chap. 11.6 Leak Test.
• Check to make sure that the defect is not in the external suction circuit parts
and replace them as required.

If the defect persists, contact the manufacturer or an authorized


service provider.

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13 CLEANING AND MAINTENANCE

13.1 General

• When working with disinfectants, observe the relevant disinfectant operating


instructions and the hygiene regulations.
• When working with disinfectants, observe the occupational health and safety
rules, use the personal protective equipment and protect you skin and eyes.
• Dispose of the aspired liquids and any contaminated disposable parts of the
device in compliance with the applicable legislation.
• After reassembling the suction jar, check to make sure that the cover is put on
properly and the tubes attached firmly.

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.

13.2 Replacement of suction jars


Replace the suction jar when filled up to the maximum capacity mark (e.g. 2 l, 4 l).
Disconnect the tubes from the suction jar cover. Remove the full suction jar from the
holder carefully and dispose of the contents according to the applicable hygiene
regulations. A substitute suction jar with a cover must be readily available for quick
replacement.
The suction jar is equipped with an overfilling prevention mechanism. The aspirated
liquid level in the suction jar will raise the valve float, closing the relevant cover inlet
and interrupting the suction process. The disposable MONOKIT and FLOVAC bags
complementing the 2 l suction jars are a convenient addition in terms of quick
replacement and hygiene. The disposable bag cover includes a hydrophobic bacterial
filter which also has the function of the overfilling prevention mechanism. After filling
and closing the disposable bag, the infectious contents cannot be spilled. If the
disposable bags are used, as a rule, the suction jars need not be sterilized.
Note:
Before using the suction jar equipped with the overfilling mechanism, always check the
float in its basket (on the inner side of the suction jar cover) for being placed with the
sealing ring against the cover.
If the MONOKIT or FLOVAC disposable bag is used, do not include any MSF suction
filter in the suction circuit.

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Disassembly
Dismantle all removable parts before cleaning, disinfection or sterilization.

Note to the marking:

This symbol identifies the disposable devices not intended to be reused.


Reusing such devices may lead to losing the mechanical, chemical
or biological properties and result in cross contamination.

13.3 Device cleaning


Disconnect the device from the power source; see Chap. 11.5 Starting up and
disconnecting the device. Disinfect your hands and put on disposable gloves and
suitable protective equipment. For manual cleaning of the device, use a cloth wetted
with lukewarm water up to 40 °C. The cloth must not be soaked too much as the
solution could enter the device internals. After finishing cleaning, dry up the surface
with dry cloth or paper towel.

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.

13.4 Device disinfection


Disinfect your hands and put on disposable gloves and suitable protective equipment.
Proceed according to the disinfectant manufacturer’s instructions.
The product provided below is certified by the manufacturer as a gentle disinfectant.
Using this product does not cause material degradation.
Mikrobac®dent
Disinfection agent for all types of suction systems
• Loosens dirt and mucus efficiently
• Broad range of action
• Suitable for all common suction devices
• Pleasant aroma
• Shows a very good tolerance to materials
• Minimum frothiness
• Removes biofilm efficiently

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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.

13.5 Suction jar cleaning and sterilization


A detailed procedure for cleaning and sterilizing the suction jars is specified in the
operating instructions of the manufacturer of these medical devices. Always keep the
suction jar operating instructions available for future reference.

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.

The manufacturer recommends making regular safety & technical inspections


of the unit every 12 months with inspection reports being issued.

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.

15.1 Device disposal


The device contains metals and plastics and should be disposed of in compliance with
the applicable European directives while observing the local legislation.
In the Czech Republic, the manufacturer CHEIRÓN a.s. has joined the collective return
system for used electrical appliances. When disposing of the device in the Czech
Republic, make use of the possibility to hand it over to the electrical waste collection
points. In other countries, proceed to dispose of the device in compliance with the
applicable legislation governing the electrical waste disposal methods.

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16 PRODUCT NAMES AND ORDERING NUMBERS

16.1 Suction device


Tab. 7: The device models
Model Voltage REF Voltage REF
Victoria Portable 230 VAC 11-1112 120 VAC 11-1113
Victoria Versa 230 VAC 11-1122 120 VAC 11-1123
Victoria Thorax 230 VAC 11-1132 120 VAC 11-1133
Victoria Lipos 230 VAC 11-1142 120 VAC 11-1143
Victoria Economy 230 VAC 11-1152 120 VAC 11-1153

16.2 Medical devices


Tab. 8: Medical devices
Description Ordering Manufacturer
number
Collection jar type MAK 1000 ml complete, screw 000-110-000 Flow-Meter S.p.A.
cover
Complete collection jar 1l, polysulphone 000-110-050 Flow-Meter S.p.A.

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 000-036-001 Flow-Meter S.p.A.

Canister FLOVAC 2,0 L with 1,8 m tube 000-036-021 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.

Liner FLOVAC 2,0 L 000-036-011 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.

Catheter container 600 ml 000-210-000 Flow-Meter S.p.A.

Stop valve for adults 200467 INT'AIR MÉDICAL

Suc.filter MSF 271-022-001 CHEIRÓN a.s.

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.

Tab. 11: Entry/Exit through Device Housing


Fundamental EMC Environment of professional
Phenomenon standard or testing medical devices
method
±8 kV contact
ELECTROSTATIC
IEC 61000-4-2 ±2 kV, ±4 kV, ± 15 kV air
DISCHARGE
3 V/m (f)
Radiated RF EM
IEC 61000-4-3 80 MHz to 2.7 GHz (b)
fields (a) 80 % AM at 1 kHz (c)
Near fields of RF wireless
communication IEC 61000-4-3 See 8.10.
instruments
Magnetic fields of
30 A/m (f)
DETERMINED power IEC 61000-4-8
50 Hz or 60 Hz
frequencies (d), (e)
a) If an interface is used between the simulation of PATIENT’S physiological signal and the ME
EQUIPMENT or ME SYSTEM, it should be positioned within 0.1 m from the vertical plane of
the homogeneous field area in one ME INSTRUMENT or ME SYSTEM orientation.
b) The ME EQUIPMENT or ME SYSTEMS which receive RF electromagnetic energy
intentionally for their operation must be tested on the reception frequency. The test may be
performed on other modulation frequencies determined in the RISK MANAGEMENT
PROCESS. This test is used to assess the FUNDAMENTAL SAFETY and NECESSARY
FUNCTIONALITY of the intended receiver if the ambient signal is within the free transmission
band. It is understood that the receiver might not achieve normal reception during the test.
c) The test may be performed on other modulation frequencies determined in the RISK
MANAGEMENT PROCESS.
d) Only applies to ME EQUIPMENT or ME SYSTEMS with magnetically sensitive components
or circuits.
e) During the test, the ME EQUIPMENT or ME SYSTEM may be power supplied with any
RATED supply voltage but of the same frequency as the testing signal.
f) This testing level assumes the minimum distance between the ME EQUIPMENT or ME
SYSTEM and the power frequency magnetic field sources to be at least 15 cm. If a RISK
ANALYSIS indicates that the ME EQUIPMENT or ME SYSTEM will be used nearer than 15
cm from the power frequency magnetic field sources, the IMMUNITY TESTING LEVEL
must be set so as to be suitable for the minimum expected distance.

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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

0 % Ut - 0.5 cycle (g)


Short voltage dips (f) (p) (r)
IEC 61000-4-11 at 0°, 45°, 90°, 135°, 180°, 225°,
270°, 315°(q)
0 % Ut - 1 cycle
70% Ut - 25/30 cycles (h)
Single phase: at 0°
Voltage interruptions (f) (i) (o) (r) IEC 61000-4-11 0 % Ut – 260/300 cycles (h)
a) The test can be performed with any supply voltage within the range of the voltages set
for the ME EQUIPMENT or ME SYSTEM. If the ME EQUIPMENT or ME SYSTEM is
tested with one supply voltage, it does not need to be tested again with other voltages.
b) All ME EQUIPMENT or ME SYSTEM cables are connected during the test.
c) Calibration of current injected by pliers must be made in the 150 Ω system.
d) If the ISM or radio-amateur band, if used, is skipped during frequency stepping, a
complementary testing frequency must be used in the ISM or radio-amateur band. This
applies to every ISM and radio-amateur band within the determined frequency range.
e) The test may be performed on other modulation frequencies determined in the RISK
MANAGEMENT PROCESS.
f) ME EQUIPMENT and ME SYSTEMS with direct-current power supply intended for use with
AC/DC converters must be tested for the use of a converter which meets the specifications
of the ME EQUIPMENT or ME SYSTEM MANUFACTURER. The IMMUNITY TESTING
LEVELS are used for the alternating-current power supply of the converter.
g) Only applies to ME EQUIPMENT or ME SYSTEMS connected to a single-phase AC power
network.
h) For instance, 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.
i) ME EQUIPMENT and ME SYSTEMS with the DETERMINED input current greater than 16
A per phase must be interrupted once in 260/ 300 cycles at any angle and all phases
simultaneously (if possible). After the test, ME EQUIPMENT and ME SYSTEMS with a
backup battery must be resumed for operation with mains supply. In ME EQUIPMENT and
ME SYSTEMS with the DETERMINED input current not exceeding 16 A, all phases must
be interrupted simultaneously.
j) ME EQUIPMENT and ME SYSTEMS which have no protective device in the mains
supply circuit against surge pulses may only be tested for ±2 kV between phase/phases
and the ground and for ±1 kV between phases.
k) This does not apply to ME EQUIPMENT and ME SYSTEMS of PROTECTION CLASS II.
l) A direct coupling must be used.
m) Effective values before using modulation.
n) The ISM (industrial, scientific, medical) bands between 0.15 MHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13,553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; 40.66 MHz
to 40.70 MHz. The radio-amateur bands between 0.15 MHz and 80 MHz are 1.8 MHz to
2.0 MHz; 18.07 MHz to 18.17 MHz; 21.0 MHz to 21.4 MHZ; 24.89 MHz to 24.99 MHz; 28.0
MHz to 29.7 MHz; 50.0 MHz to 54.0 MHz.
Only applies to ME EQUIPMENT and ME SYSTEMS with the DETERMINED input current
lower or equal to 16 A per phase and ME EQUIPMENT and SYSTEMS with the
DETERMINED input current greater than 16 A per phase.
p) Only applies to ME EQUIPMENT or ME SYSTEMS with the DETERMINED input current
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lower or equal to 16 A per phase.
q) In some phase angles used for this test of ME EQUIPMENT with a transformer, the mains
supply could cause overcurrent protection activation. This can occur due to transformer
core magnetic flux saturation after a short voltage dip. If this occurs, the ME EQUIPMENT
or ME SYSTEM must provide BASIC SAFETY during and after the test.
r) In the ME EQUIPMENT and ME SYSTEMS which have more voltage settings or ability of
automatic voltage selection, the test must be performed with the minimum and maximum
DETERMINED supply voltage. The ME EQUIPMENT or ME SYSTEMS with the range of
DETERMINED supply voltages less than 25 % of the highest DETERMINED supply
voltage must be tested with one DETERMINED supply voltage within the range.

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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.

a) Uplink frequencies are only included for some services.


b) The carrier wave must be modulated while using the 50 % duty factor of the rectangular signal.
c) As an alternative to FM modulation, 50 % pulse modulation on 18 Hz can be used because even if it
does not represent actual modulation, it would be the worst case.

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18 LIST OF REVISIONS

Tab. 14: 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.

25.05.2021 210525 Change of the manufacturer's registered office address.


Minor adjustments to the text.
21.06.2021 210621 Edit the device accessory list.

24.02.2022 220224 Art. 4.2 Changing the text of the article


Change tab. No. 5

19 MANUFACTURER’S / SUPPLIER’S CONTACT DATA

CHEIRÓN a.s.

Address: Kukulova 24, Břevnov, 169 00 Praha 6, Czech Republic

Branch: Republikánská 1102/45, 312 00 Plzeň, Czech Republic


+420 377 590 422 Sales Dpt.
+420 377 590 455 Service

Fax: +420 377 590 435

E-mail: obchod@cheiron.eu; cheiron@cheiron.eu


URL: www.cheiron.eu

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