SCANER MK-200 User manual

COLPOSCOPE MK-200
Operation Manual

COLPOSCOPE MK-200
Operation Manual

Table of contents
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
2
Table of contents
1. Safe Usage Guidelines................................................................................................4
1.1. Symbols used in the manual.................................................................................6
1.2. Operating conditions.............................................................................................6
1.3. Marking and symbols............................................................................................7
1.4. Warnings and cautions..........................................................................................7
2. The field of use, design and appearance.....................................................................9
2.1. Tripod floor..........................................................................................................10
2.2. Power supply unit................................................................................................11
2.3. Balancing lever ...................................................................................................11
2.4. Colposcope head................................................................................................11
3. Complete set .............................................................................................................13
4. Specifications ............................................................................................................15
4.1. Optical parameters..............................................................................................15
4.2. Technical parameters..........................................................................................16
4.3. System settings...................................................................................................17
5. Mounting and installation...........................................................................................18
5.1. Mounting of the tripod floor .................................................................................19
5.2. Power supply unit installation..............................................................................20
5.3. Installation of colposcope head...........................................................................21
5.4. Connecting the cables.........................................................................................22
5.5. Installation of the U-shaped handle.....................................................................25
6. Operation...................................................................................................................26
6.1. Turning on the colposcope. Moving, fixing and adjusting the travel force of
its movable parts........................................................................................................26
6.2. The adjustment of interpupillary distance of the eyepieces and adjustment
of the diopter values...................................................................................................28
6.3. The switching of magnifications of the optical system.........................................29
6.4. The use of the filter lens......................................................................................30
6.5. Fine focusing lens...............................................................................................31
6.6. The use of video system.....................................................................................32
6.7. Spatial movement of the colposcope head .........................................................33
6.8. Adjustment of the tilt of the balancing leaver.......................................................34
7. Colposcope care........................................................................................................35
7.1. Cleaning and disinfecting external surfaces........................................................35

Table of contents
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Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
7.2. Cleaning optical surfaces....................................................................................35
8. Possible malfunctions and ways of their elimination..................................................36
8.1. Replacement of the fuse element .......................................................................37

Safe Usage Guidelines
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
4
1. Safe Usage Guidelines
ATTENTION. Before using this product, please read this manual carefully.
This manual contains important safe usage guidelines and technical
maintenance of the colposcope MK-200 (hereinafter referred to as colposcope). To
ensure operational safety, follow the instructions and warnings contained in this manual.
ATTENTION. In case of using colposcope for purposes that are different
from described in this manual, there is a risk of getting injuries and material
damage.
This manual does not explain the clinical procedures of colposcopy. The
personnel using the colposcope must have an appropriate level of qualification and
training, or use colposcope under the supervision of a doctor with an appropriate level
of qualification.
This manual must be kept in a safe and accessible place, so that the personnel
using the colposcope always have access to it.
If you have any questions related to the operation, adjustment or maintenance of
the colposcope, please contact the manufacturer or the authorized representative of the
manufacturer.
Manufacturer:
Science & Engineering Center Scaner, Ltd.
122/1 Smilianska st., 18019 Cherkasy, Ukraine
E-mail: [email protected]
http://www.scaner.ua
Tel/Fax: [phone](34)
0-800-30-10-19 (free calls from fixed phones on the territory of Ukraine)
Representative in EU:
Medicor-Pol Zaklad Techniki Medycznej Sp. Z o.o.
233 Kilinskiego st., 93-133 Lodz, Poland
E-mail: [email protected]
http://www.medicorpol.com.pl
Tel/Fax: [phone] [phone]

Safe Usage Guidelines
5
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
The company Science & Engineering Center Scaner, Ltd. develops and
produces medical devices in accordance with the quality management system
ISO 13485:2016. The entire production process is subject to constant quality inspection
and undergoes a periodic check by inspection audits.
The colposcope MK-200 corresponds to the provisions of the European Directive
of Medical Devices 93/42/EEC and the Technical Regulations on Medical Devices of
Ukraine.

Safe Usage Guidelines
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
6
1.1. Symbols used in the manual
The text with warnings and mandatory requirements for safety is marked with
graphic symbols and words: ATTENTION or PROHIBITED.
ATTENTION. It is necessary to pay special attention to the instructions in
order to avoid the mistakes during operation.
PROHIBITED. Actions, which are strictly prohibited and pose a danger to
human health or may damage the device.
1.2. Operating conditions
The colposcope is intended for use in medical institutions of health. According to
the operating conditions the colposcope is intended for work at ambient temperature
from +10ºС to +40ºС, relative humidity from 30% to 75%, and atmospheric pressure
from 700 hPa till 1060 hPa.
Depending on the potential usage risk in medical practice, the colposcope
belongs to the class I according to DSTU (National Standard of Ukraine) 4388 (Class I,
Medical Device Directive 93/42/EEC).
ATTENTION. Avoid getting any liquid inside the colposcope.
PROHIBITED. To keep and use the colposcope in places with prolonged
exposure of direct sunlight, as well as with impact of X-ray beams or strong
electromagnetic radiation.

Safe Usage Guidelines
7
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
1.3. Marking and symbols
A device symbol of class II. The device
has a double reinforced insulation – the
conducting parts are provided with
additional (to the operational) protective
insulation. Grounding connection is
prohibited. According to
DSTU EN 60601-1-1
A protection degree symbol of electrical
devices. Protection against penetration
of the tool covering, wires etc. with
diameter or thickness > 2.5 mm and size
of solids > 2.5 mm. According to
DSTU EN 60529
The symbol indicating the name and
address of the authorized
representative in the European Union
Acco ISO 15223-1rding to DSTU EN
A symbol indicating the name and
address of the manufacturer, who is
responsible for the device. According
to DSTU EN ISO 15223-1
A symbol indicating the date of the
device manufacture. According to
DSTU EN ISO 15223-1
A symbol “Attention! Refer to the
accompanying documents”
DSTU EN 60601-1-1, DSTU EN ISO
15223-1
A serial (factory)
number of the device
DSTU EN ISO 15223-1
TU U 33.1-14180968-002-2001
COLPOSCOPE MK-200
F1-3A
~ V220 ,
50 ,Hz
15VA
EC REP
Medicor-Pol Zaklad Techniki
Medycznej Sp. Z o.o.
233 Kilinskiego st., 93-133
Lodz, Poland
Science & Engineering Center
Scaner, Ltd.
122/1 Smilianska st., 18019
Cherkasy, Ukraine
SN-12345620xx
1.4. Warnings and cautions
When assembling, operating and maintaining the colposcope, follow the
warnings and cautions below. This information should be updated with warnings and
cautions given in each chapter
ATTENTION. Before operation, make sure that the colposcope is in good
working condition.
ATTENTION. For safety reasons the continuous work time of the
colposcope (work of the illuminator) should be no more than 4 hours with
following break for 30 minutes at least.
ATTENTION. The colposcope connection to the single-phase AC mains
with voltage of 220 V is carried out only with electric cable from the supply
kit.
PROHIBITED. To disconnect and disassemble any parts of the
colposcope, other than specified in this manual.
PROHIBITED. To fully unscrew and remove the force adjustment knob and
the movement adjustment handle of the colposcope moving parts during its
operation.
ATTENTION. Each moving part of the colposcope has its limited range of
motion. Do not try to increase this range by moving the colposcope beyond
these limits with excessive force.

Safe Usage Guidelines
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
8
ATTENTION. Ensure that the electrical cable plugs are firmly fixed in the
appropriate sockets during work with colposcope, and the cables do not
get into the moving parts of the device and do not wrap around during
manipulations and displacements.
PROHIBITED. To look into the lens of the colposcope, when the illuminator
is on, this can cause damage to the retina.
ATTENTION. Before cleaning and disinfection of external surfaces it is
necessary to turn off the colposcope from the power source.

Design and appearance
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Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
2. The field of use, design and appearance
The colposcope MK-200 is a medical device intended for stereoscopic
observation with optical magnification by a non-contact method: of the vagina, cervix
and the lower third of the cervical canal during gynecology and oncogynecology
research. The construction of the colposcope has all necessary moving elements and a
large number of freedom degrees that allows focusing smoothly and fixing securely the
colposcope head at the observation object. The colposcope is mounted on a tripod floor
with self-aligning rollers which enables free movement of the device across the floor.
The colposcope field of use: gynecology and oncogynecology.
The colposcope is required for:
observation under optical magnification the condition of the epithelium of
cervix, vagina and vulva;
identification of the location and lesion borders;
differentiation of benign changes from suspicious regarding the malignancy;
a target cytosmears and biopsy that essentially increase the informativeness;
medical treatment under optical control (operational colposcopy);
monitoring the treatment results;
dynamics assessment of the process development when choosing a
conservative tactics of patient management.
The colposcope can be supplied with a video system intended for digital photo
and video documentation.

Design and appearance
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
10
2.1. Tripod floor
Tripod floor (hereinafter referred to as tripod) is a mobile base on 5 self-aligning
rollers. The rollers of the tripod have a locking feature rolling to prevent spontaneous
movements.

Design and appearance
11
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
2.2. Power supply unit
The power supply unit of the colposcope provides the LED illuminator with
stabilized constant current. The power supply unit is mounted on the tripod floor and
used as a pivoted lever.
2.3. Balancing lever
The balancing lever is intended to hold and trim the colposcope head. The
balancing lever is installed at the power unit and it forms two pivoted levers in
connection with it.
2.4. Colposcope head
The colposcope head consists of:
optical head;
lens;
video system;
binocular adjustment with eyepieces;
illuminator.
The optical head has a built-in 5-step drum of the magnification changer
performed in optical systems of Galileo that have magnification ratio of: 0,4x; 0,6x; 1x;
1,6x; 2,5x.
The lens is intended to focus on the observation object. The lens has a fine
focusing mechanism, which can adjust the visible sharpness of the image in the range
of 12 mm without changing the position of the colposcope head. A colposcope can be
supplied with lenses with a focal length:
f=200 mm (with fine focus) (option);
f=250 mm (with fine focus);
f=300 mm (with fine focus) (option);
f=350 mm (option);
variable lens 200 –400 mm (with handle) (option).
The binocular adjustment is intended for stereoscopic image output of the
observed object on the retina. The binocular adjustment consists of the lens-prism unit
with eyepieces at a 45° angle on the colposcope sighting axis and has a mechanism of
interpupillary distance variation (hereinafter referred to as interpupillary distance)
between the eyepieces in the range from 56 mm to 74 mm.
The eyepieces have a mechanism for changing dioptries within +5 -5 D, for each
eyepiece. Diopter correction enables doctors to work with ametropia without glasses.
The colposcope can be supplied with eyepieces magnification of 12,5х or 16х (option).

Design and appearance
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
12
The integrated into the optical head illuminator is designed for coaxial
illumination of the object. The optical system of the illuminator forms in the observation
plane a bright, even and unflickering light spot with clear borders from the integrated
LED source. The illuminator has the possibility of the introduction of green filter intended
to enhance contrast of the blood vessels.
The video system is intended to view a colorful image of the observed area at
the computer screen in real time, as well as video recording and taking high resolution
snapshots (1920x1080). The video system is installed between the optical head and the
binocular adjustment of the colposcope without compromising of the optical
characteristics, and the transmitted video image coincides with the image observed
through the eyepieces of the colposcope.

Complete set
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Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
3. Complete set
Optical head
1
Lens:
1
- f=200 mm (with fine focus) (optional)
- f=250 mm (with fine focus)
- f=300 mm (with fine focus) (optional)
- f=350 mm (optional)
- variable lens 200 –400 mm (with handle) (optional)
Binocular adjustment 45°
1
Eyepieces:
2
- 12.5х
- 16х (optional)
U-shaped handle (optional)
1
Colposcope video system MK-200:
(may not be supplied, at the customer's request)
- digital video system
1
- additional USB cable (5 m)
(only for export, or at the request of the customer)
1
- software for colposcopic diagnosis MEDVisor-EVA
1
- the protection key for the software
1
- the user manual for software MEDVisor-EVA
1
Power supply and balancing lever
1
Tripod floor
- stand
1
- casing
1
- mobile base
1
Power cord
1
Spare parts, tools and accessories (SPTA):
- fuse
2
- screwdriver
1
- allen key
1
- protective case
1
Operation Manual
1
Passport
1
Packaging
4

Complete set
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
14
ATTENTION. Before starting the installation and operation of of
colposcope, the availability of all components in the supply kit must be
checked. In the absence of any supplied component, please contact the
supplier.
ATTENTION. Ensure that there is no possible damage of the colposcope
components associated with transportation, such as: constrained
deformation, holes and cracks, breach of lacquer coating.
If you find damage, contact the supplier.

Specifications
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Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
4. Specifications
4.1. Optical parameters
Magnification of eyepieces
12.5x
16х
Optical head magnification,
ratio
0.4
0.6
1
1.6
2.5
0.4
0.6
1
1.6
2.5
Lens f=200
General magnification, ratio
4.1
6.6
10.5
16.9
27
4.9
7.9
12.6
20.3
32.4
Field of view Ø, mm
53.6
33.3
21
13
8.1
44.9
27.8
17.5
10.8
6.8
Resolution, lines/mm
40
60
75
85
90
44
70
85
90
90
Lens f=250
General magnification, ratio
3.3
5.3
8.5
13.6
22
4
6.4
10.2
16.3
26
Field of view Ø, mm
66
42
26
16
10
55
34
21.6
13.5
8.5
Resolution, lines/mm
32
50
70
85
90
35
55
75
85
90
Lens f=300
General magnification, ratio
2.8
4.5
7.1
11.4
18.3
3.3
5.3
8.5
13.6
22
Field of view Ø, mm
78.6
48.9
31
19.3
12
66
42
26
16
10
Resolution, lines/mm
26
40
60
70
75
32
50
70
85
90
Lens f=350
General magnification, ratio
2.4
3.8
6.1
9.8
15.7
2.9
4.6
7.3
11.8
18.8
Field of view Ø, mm
91.6
57.9
36
22.4
14
75.8
47.8
30.1
18.6
11.7
Resolution, lines/mm
23
36
50
60
65
26
40
60
70
75
Variofocal lens
With magnification of eyepiece 12.5x
Working distance, mm
General magnification, ratio
Field of view Ø, mm
200
2.9 - 18.9
75.8 - 11.6
250
2.5 - 16.2
88.0 - 13.6
300
2.2 - 14.3
100 - 15.4
350
2.0 - 12.8
110 - 17.2
400
1.8 - 11.6
122.2 - 19
With magnification of eyepiece 16x
Working distance, mm
General magnification, ratio
Field of view Ø, mm
200
3.7 - 24.2
59.4 - 9.1
250
3.2 - 20.7
68,8 –10.6
300
2.8 - 18.3
78.6 - 12
350
2.6 - 16.4
84.6 - 13.4
400
2.3 - 14.8
95.6 - 14.8

Specifications
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
16
4.2. Technical parameters
The eyepiece diopter movement, D
+5 -5
The range of interpupillary distance variation, mm
from 56 to 74
The diameter of the illuminated field of view, mm, not less:
- with installed lens f=200 mm
55
- with installed lens f=250 mm
68
- with installed lens f=300 mm
80
- with installed lens f=350 mm
90
The maximum illumination in the subject plane, lux, not less:
- with installed lens f=200 mm
90 000
- with installed lens f=250 mm
60 000
- with installed lens f=300 mm
40 000
- with installed lens f=350 mm
30 000
Power supply voltage from the single phase AC current with
frequency of 50 Hz, V
from 90 to 250
Power consumed by the colposcope, VA, not more
15
The colposcope weight, kg, not more
36.5

Specifications
17
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
4.3. System settings
30°4360°
480 mm
227mm
505 mm
Ø 55 mm3
max 12 5 mm
4
min mm
990
340°
40°
max 1 mm
140
min8 5mm
8

Mounting and installation
Colposcope MK-200 Operation Manual (revision: 31 date: 06.07.2020)
18
5. Mounting and installation
The colposcope MK-200 is supplied in a package consisting of 4 seats.
Before the start of device mounting, it is necessary to extract all its components
from the transport container and remove the packaging material.
Use the tools from the supply kit (spare tools and equipment) for the colposcope
mounting and installation.
ATTENTION. Before starting the installation and operation of of
colposcope, the availability of all components in the supply kit must be
checked. In the absence of any supplied component, please contact the
supplier.
ATTENTION. Ensure that there is no possible damage of the colposcope
components associated with transportation, such as: constrained
deformation, holes and cracks, breach of lacquer coating.
If you find damage, contact the supplier.