Authentic Manufacturer of Hi-Tech Medical Devices
USER’S MANUAL
Digital Video Colposcope
Model: COLpro222DX-OZview
Divine Meditech Pvt Ltd
G-197, Sector-63, Gautam Buddha Nagar
Uttar Pradesh, India-201301
Meddevices Lifesciences
B.V.Keizersgracht 482,
1017 EG Amsterdam, the Netherlands
Operator’s Manual Ver. DMPL-STD-222
- 1 -
COLpro222DX-OZview
Table of Contents
SEC.
1 PREFACE
2
SEC.
2
DESCRIPTION
OF
COLpro222DX
-
OZview
2
SEC.
3
GENERAL
WARNINGS
AND PRECAUTIONS
2
SEC.
4 INSTALLATION
4
SEC.
5
TECHNICAL
SPECIFICATIONS
10
SEC.
6 LIST OF REPLACEMENT
PARTS
10
SEC.
7
SYSTEM
MAINTENANCE
11
SEC.
8
WARRANTY
TERMS
AND CONDITIONS
(WORLD
-
WIDE
PURCHASE)
12
SEC.
9
LABELLING
FORMAT
FOR TRACEABILITY
13
SEC. 10 ACCESSORIES CHECK LIST
14
Sec 1 PREFACE
This manual contains information, which may not be copied or duplicated, in full or in part, without the explicit
approval of Divine Meditech Pvt Ltd (INDIA). We reserve the right to make any change in the operator manual, which
may affect instructions in this manual, without giving prior notice. The user of this equipment shall be solely
responsible for any kind of damage, malfunction to the unit or user as a result of improper use or any kind of repair or
alteration done by anyone other than us or a technician duly authorized by the manufacturer to do so.
This operator manual provides directions for using COLpro222DX-OZview Digital Video Colposcope. Read all
instructions, cautions and warnings prior to use. Failure to follow instructions or to heed warnings could lead to
patient or operator injury. COLpro222DX-OZview version is our newest, most advanced and recently upgraded model
of our COLpro222DX series. Many additional facilities have been added according to the feedback received from
various users and stakeholders of our widely acclaimed COLpro222DX series. The Delivered Product may vary
slightly in color or shape or specifications due to continuous product development.
Sec 2 DESCRIPTION OF COLpro222DX-OZview
COLpro222DX-OZview is an aid to colposcopy. Colposcopy is a gynecological procedure in which the doctor, using
colposcope looks at the cervix. It comprises of a camera head mounted on a vertical stand. This instrument magnifies
the cervix, vagina and external genital area when the doctor points out the camera head at the vagina where a
speculum has been placed.
It incorporates latest digital signal processing technology to provide high-resolution images for effective colposcopy. It
is a latest generation video colposcope incorporating advanced CCD imaging & illumination technology, aerodynamic
design, compact size and offers powerful features like automatic as well as manual focus, electronic multi-grade
green filter and magnification indicator among many others. The extra innovative features added are e-flip & mirror
image, facility to vary the light intensity, facility to choose various color contrasts to make colposcopy more effective.
COLpro222DX-OZview is designed to detect the presence of pre-cancerous tissue or cancerous tissue or any
abnormality in cervix area. So far colposcopy plays a significant role in evaluation and treatment of cervical infection
like cervical cancer, erosion and inflammation. This manual has been prepared to provide authorized personnel with
information on the assembly, functions and routine performance related to the COLpro222DX-OZview. It is provided
together with the device and should be available near the device all the time. The user must read and be familiar with
the contents of this manual before using the video colposcope. Operation must be performed in accordance with
stipulated safety standard thus to ensure patient and operator’s safety.
Sec 3 GENERAL WARNINGS & PRECAUTIONS
Intended Use:
to investigate abnormal cervical cytology or suspicious lesions of the lower female genital tract. Also used for
corresponding biopsy and treatment, when indicated.
Environmental Requirements:
Area of camera & Floor stand pole: 0. 4m2
Ambient temperature: 50C - 400C
Humidity: < 80%
Atmospheric pressure: 70 kPa-106kPa
AC 100~240 V, 50/60 Hz
Well-grounded
Operator’s Manual Ver. DMPL-STD-222
For examination of the tissues of the vagina, cervix and external genitalia by means of magnification
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COLpro222DX-OZview
Symbols and Terminology:
WARNINGS
Attention: Consult user’s manual for additional information
Caution: This statement identifies a condition or practice, which if not corrected or discontinued
immediately, could lead to equipment failure or damage
Warning: This identifies a condition or symbols practice, which if not corrected or discontinued
immediately, could lead to patient injury / illness
The Colposcope must be connected to a properly installed power outlet with protective earth contacts only. Operation
room should be ventilated and free of shock, noise, other strong interference source and direct sunlight.
Users of this equipment should be thoroughly trained in the appropriate medical procedures. They should take
time to read and understand these instructions before performing any procedure. They can also read and follow
instructions for any other equipment used in conjuction with the Colposcope.
The Colposcope should not be operated in the presence of flammable or explosive gases or chemicals, or
installed in areas where these materials are commonly used.
Keep all liquids away from electrical equipment to avoid the possibility of shock and instrument damage.
Colposcope user should adhere to the operating conditions found in this manual. Otherwise, instrument damage
may occur and patient safety may be compromised.
All signal input and output are intended for connection to only peripheral devices that are compliant to
IEC 60601 - 1 or other IEC standards as appropriate to the nature of the peripheral device. Connecting additional
peripheral to the video colposcope may increase the risk associated with chassis or patient leakage currents. To
maintain operator & patient safety, the user should consider the system leakage current requirements of IEC
60601-1.
Never stare at the illuminator because it is extremely bright and may cause injury to theeye.
CAUTIONS
Occasionally inspect the power cord for signs of cuts, abrasions or dents.
The colposcope should never be stored or operated in areas where it could get wet or could be exposed to any
environmental conditions like extreme temperature or humidity, direct sunlight, dust etc.
There are no user serviceable parts in this unit or in its accessories. Any attempt to disassemble and repair this
unit will result in voiding of the warranty.
Do not clean illuminator or lens with alcohol. Do not touch optical parts or lenses.
Do not sterilize
Do not immerse any part of the unit in cleaning solutions.
PRECAUTIONS
Colposcope Safety:
to the instrument. The importance is not related to the sequence. NOTE: This is not a treatment device.
Please confirm the colposcope is in normal working condition before operation.
Without losing knob, the excessive force may damage twin axis adapter of colposcope head.
This is non-contact type examination device, avoid contacting patient during use.
Before turning off power supply of the whole system, never plug or unplug the video cable.
Without written approval of the manufacturer, user shall not remove, modify or use accessories, which do not
comply with the manufacturer’s requirements.
When connecting the signal cables, handle them carefully. Align the connectors, do not plug or unplug with strong
force, otherwise, the cable and connectors may be damaged, which will impact the image quality or camera
power supply or even the equipment.
Operator’s Manual Ver. DMPL-STD-222
The safety requirement mentioned in this section is for Colposcope as a whole and applies
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COLpro222DX-OZview
When not in use, the colposcope power supply shall be turned off, and the camera shall be covered to prevent
dust.
To prevent accidental power failure and other potential accidents, use uninterruptible power system with the
colposcope.
Before cleaning the system, make sure to disconnect the system power cable.
Clean according to the items specified by Divine Meditech Pvt Ltd (INDIA).
Keep cellular phones away from the device.
Packing materials should be put away from children reach or handled according to related regulations.
In case any doubt arises, please consult with Divine Meditech Pvt Ltd (INDIA). as soon as possible.
Please comply with the items stipulated in the manual. This manual is not the replacement of medical regulations.
Sec 4 INSTALLATION
COLpro222DX-OZview is an easy system to install. Please be sure that all electrical, electronic and environmental
requirements are met before installation of the system.
Installation: Composition & Assembly
Vertical Pole Composition:
connected to the external display monitor to constitute a complete diagnosis system. It can also be connected to
computer workstation to save, analyze print patient information etc. Its height can be adjusted according to actual
needs.
Vertical pole (lower) “FIGURE A. 4.” with interface box “FIGURE A. 5.” can be
External Cable of interface box
Use accompanying power cord; insert one end into “FIGURE B. 3.” and the other end to power socket in
wall.
Connect one end of S-Video cable / BNC cable to “FIGURE B. 1.” / “FIGURE B. 2.” and the other end to an
external display monitor.
Fig. A. Vertical stand Interface Box Composition Fig. B Interface Box
Operator’s Manual Ver. DMPL-STD-222
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COLpro222DX-OZview
STEP 1
Grasp the lower vertical pole “FIGURE A. 4.” and put it
into the middle hole of rolling base “FIGURE A. 6.”
ASSEMBLING STEPS
STEP 2
Screw-in the nut “FIGURE A. 7.”
Step 1 Step 2
STEP 3
Lie down the lower vertical pole “FIGURE A. 4.”, fix the
nut “FIGURE A. 7.” by rotating it clockwise, thus to fix
rolling base “FIGURE A. 6.” and lower vertical pole
“FIGURE A. 4.”
STEP 4
Insert the camera head cable (grey) into the
hole of vertex plate adapter “FIGURE A. 1.”
Step 3
- 5 -
Reference picture for Step 4
COLpro222DX-OZview
Make sure to insert the camera head cable through the first hole
of vertex plate adaptor 1
reference picture.
Operator’s Manual Ver. DMPL-STD-222
st
and then 2
nd
hole as shown in the
STEP 5
Push the cable through the upper vertical pole
“FIGURE A. 3.” Until the cable comes out. Do not fix
the camera on twin axis adapter now. It can cause
cable twisting.
ASSEMBLING STEPS
STEP 6
Connect the cable which came out in Step
5 and connect it carefully to the cable
coming out of the lower vertical pole
“FIGURE A. 3.” as shown in the. Please
ensure to match both the arrows marking
pasted on the cables.
Step 5
Step 6
STEP 7
Rotate the upper vertical pole “FIGURE A. 3.”
clockwise and connect it with the lower vertical
pole“FIGURE A. 4.”. Then rotate the camera
according to the moving direction of cable, thus
to avoid twisting or damaging of the cable.
Step 7
Operator’s Manual Ver. DMPL-STD-222
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COLpro222DX-OZview
STEP 8
Pull the latch of vertex plate adaptor with thumb
outside by 900, grasp the camera’s handle
carefully and put the fixing base (which is
attached to the camera head) into vertex plate
adaptor. When the camera head is attached,
release the hand grip of vertex plate.
Step 8
Please connect the electrical power cord to the AC power inlet provided on the Interface box. The other end of the power cord
must be connected to a Hospital grade AC power outlet (100-240 VAC, 50/60 Hz). Interface box has SVHS video output & BNC
output for connection to a suitable video device such as Medical grade monitor. Switch ON the main power button provided on the
camera head panel. The system is now ready for use.
Operator’s Manual Ver. DMPL-STD-222
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COLpro222DX-OZview
CAMERA HEAD CONTROL PANEL – FUNCTIONS
LED for Power
A.
M
L
K
J
H
O
B.
n/Off Switch
C. LED for Auto Focus
D.
Auto Focus
E.
A
B
C
D
E
I
F
G
Intensity Variation /
anual Focus
M
F. Pause or freeze
reen Filter On
G.
G
H.
reen Filter Off and color
G
contrast selector
I.
Zoom Out
J. Zoom In
K. Timer & Zoom Factor Display
L. E-Flip
M.
Mirror Image
M
◦
LED for Power
LED next to the ON/OFF Switch lights up, when power is ON from ON/OFF
switch
(B)
ON/OFF Switch
◦
LED for Auto Focus
Auto Focus
Intensity Variation
Pause or Freeze
Green Filter ON
& Blue Filter
Press once to get the device camera and illuminator ON & if pressed again, it
will turn OFF.
If the LED next to Auto Focus lights up, it means that the camera is in the
auto focusing mode. When it goes off, it means that the device is in manual
focus mode. When the camera is in auto focus mode, it searches the object
automatically & adjusts the image clarity according to the distance between
the Colposcope & the object. When the LED goes off, then the camera is in
manual focus mode & it needs to be directed towards the object & could be
manually adjusted to the clearest image.
Under default condition, the unit stays in Auto focus mode that means LED
(C)
is glowing. To switch ON the manual focus mode, press the auto focus
button again. Under this condition, LED (C) goes off.
a.
: When the colposcope is in auto focus mode (i.e Auto Focus LED is
glowing) then this button works as an intensity mode selector. One of the 5
Levels of Intensity can be selected by pressing this button. Level of intensity
is indicated by l1, I2 I5 on screen. I1 is the brightest of all.
b.
Manual Focus: When the camera is in manual focus mode (i.e Auto Focus
LED is not glowing), press this button to start manual focus.
This button allows you to freeze the required image that needs to be stored
for reviewing. Press the button again, image will be unfrozen.
Press this button to get the green filter ON & the system will automatically
filter the red tissue in the image being observed and highlight the enhanced
vascular image. It also gives the excellent color contrast for viewing vascular
pattern without any light loss.
One of the 4 levels of green filter can be selected by pressing this button.
First push of this button, switches from Normal image to Green Image G1/
thereafter, each next push of this button selects next levels of Green Filter.
Green Filter status is Indicated by G1, G2, G3, G4 on screen.
Press this same button to get the Blue filter ON. First push of this button,
Operator’s Manual Ver. DMPL-STD-222
- 8 -
COLpro222DX-OZview
A
D
E
I
Zoom
- In
Mirror
-
Image
switches from Normal image to Green Image. Each next push of this button
selects next levels of Green Filter G1, G2, G3, G4. The next and last push
will be B for Blue Filter.
Green Filter OFF and color
contrast selector
Zoom-Out
Timer & Zoom factor
display
E-Flip
Press it once to switch green filter mode into normal Image mode. One of the
5 Color levels of Normal Image can also be selected by pressing this button.
First push of this button switches Green Image into Normal Image N1.
Thereafter, each next push of this button selects next levels of color
contrasts which is indicated by N1, N2 N5 on screen
Press this button to close the Zoom in factor
This button allows zooming of the image up to a certain level where one can
view the tissues & vessels more clearly.
Press this button to start the display of current magnification status and timer
on the connected display. Press again to switch off this function.
E-flip function enables the image to rotate upside down for a better viewing of
the vascular pattern. (Letter ‘E’ displayed on the screen denotes – this
function is ‘ON’.
Mirror Image gives a side view of the image for better diagnosis. (Letter ‘M’
displayed on the screen denotes – this function is ‘ON’.
REMOTE CONTROL FUNCTIONS
B
A.
Gamma ON
B.
Gamma OFF
C.
Zoom IN
D.
Zoom OUT
E.
Pause
Green Filter ON
F.
Green Filter OFF
G.
H.
Manual Focus
I.
Auto Focus
J.
Timer & Zoom Factor Display
K.
Mirror Image
L.
E-Flip
G
C
F
J
H
L
K
Operator’s Manual Ver. DMPL-STD-222
- 9 -
COLpro222DX-OZview
o
1 Head Cabinet
DVC-CH-011 /012
2 Illuminator
DVC-IL-005 / 015
3 Micro Controller
Unit Board
DVC-MC-007
4
8 Core Cable
Assembly(Head
Side) DVC-CM-003
5 8 Core Cable
Assembly(Interface
Panel Side) DVC-CF-004
6 Interface
Panel DVC-IP-002
7
Stand
with vertex
DVC-STD-001 /011 8 Camera
Module
DVC-KM-008 9 SVHS
Cable
DVC-SV-014
10 BNC to RC Cable
DVC-BN-013
Australia
DVC-PC-017
Sec 5 TECHNICAL SPECIFICATIONS
Image Processor
Pixels
Resolution
E-Flip
Mirror Image
Electronic Shutter
Signal to noise ratio:
Illumination
SONY Color CCD
12 00 000
> 825 lines (standard), or > 1000 (with Gamma ON)
Yes
Yes
Automatic
> 48 db
High MCD super bright white shadow less LED light
Color Temperature
Test Timer
Multigrade Electronic Green Filter
Blue Filter
Variable color contrast
Variable light intensity
Focus
Focus Distance
Zoom
Viewing area
Depth of view
Magnification display
Video Outputs
Safety Standard
Gamma Processor
Remote control (optional)
Power Supply
7000 K
Yes
Yes (4 steps)
Yes
Yes (5 steps)
Yes (5 steps)
Automatic and Manual
20 – 30cm / 30 - 40 cm (Optional)
1 – 55x
170mm – 10mm
200mm – 5mm
Yes
1 X SVHS, 1 X Video Composite
Complies to IEC 60601
Optional (through remote)
For operative functions
100-240 VAC, 50/60 Hz
Sec 6 LIST OF REPLACEMENT PARTS
Sl No
Part Description
Part Number
11
Power Cord
Operator’s Manual Ver: DMPL-STD-222
Europe
USA
South Africa & India
DVC-PC-018
DVC-PC-016
DVC-PC-015
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COLpro222DX-OZview
Sec 7 SYSTEM MAINTENANCE
Cleaning Agent
1.
2.
3.
4.
5.
: Examples of disinfectants that can be used on the colposcope unit are listed below:
Dilute Sodium Hypoclorite (Bleaching Agent)
Diluted Formaldehyde 35%-37%
Hydrogen peroxide 3%
Alcohol 75%
Isopropanol 70%
The Digital Video colposcope can be cleaned with hospital-grade ethanol and dried in air or with crisp and clean
cloth.
Cleaning Steps:
Turn off camera & colposcope, cut the connection with AC power supply.
Clean external part and stand
Clean connecting cables.
Wipe all the cleaned parts with dry cloth.
Warnings
Colposcope should be powered off and disconnected from AC power before cleaning.
Do not attempt to immerse any part of the equipment in cleaning solutions.
Do not use abrasive material to clean any part of Colposcope.
Do not use strong solvents to clean any part of Colposcope.
Do not leave any solution residue on the device, if so, please wipe it off quickly with a cloth damped in water
MAINTENANCE:
Please examine the following before using colposcope:
Examine whether there is any mechanical damage
-
Examine all external cables, insert parts and accessories.
-
Examine all parts, which connect to patients and make sure they are in good working condition.
-
If any damage is found, please contact manufacturer or its authorized technical personnel engineer.
-
When inspecting the system, pay attention to the following:
Make a visual inspection to ensure there are no damaged parts.
-
Make sure that there is no damage between plug and cable, and all the pins and plugs are not loose.
-
-
Check whether the connection between vertical stand, monitor & camera is correct & unbroken.
Check there is no cable breakage by moving each end of the cable.
-
Camera Head Maintenance:
-
Camera head is an important part of colposcope, dust particles can accumulate on it and may affect colposcope
performance, if fingerprint is left on the camera lens it could lower the image quality and it is really harmful to the
camera lens coating, so it should be removed / cleaned quickly.
Use soft brush to clean the camera.
-
Put a drop of camera lens rinse solution on cotton paper, then use it to wipe camera surface.
-
Maintenance of unit
Do not attempt to immerse any part of the equipment in cleaning solutions.
-
Do not use abrasive material to clean any part of Colposcope.
-
Do not use strong solvents to clean any part of Colposcope.
-
-
Do not leave any solution residue on the device, if so, please wipe it off quickly with a cloth damped in
water
Operator’s Manual Ver: DMPL-STD-222
- 11 -
COLpro222DX-OZview
Sec 8 WARRANTY TERMS AND CONDITIONS
Subject to any other statutory right or remedy and the warranty conditions below, this new Divine Digital Video
Colposcope COLpro222DX-OZview is expressly warranted by Divine Meditech Pvt Ltd (INDIA) to be free from
defects, and to conform to product descriptions and specifications as described in this document for a period of 1
year from the date of original delivery of the COLpro222DX-OZview unit by us or Dealer or Agent to the customer.
This warranty applies only to an original purchase world-wide from us or Dealer or Agent.
This warranty shall not cover damage malfunction or failure resulting from the use of COLpro222DX-OZview other
than in accordance with the instructions contained in this operator manual, accident, misuse or misapplication,
improper or unauthorized repair, neglect, modification or use of unauthorized accessories or improper voltage.
The warranty shall be void if the rating label or serial number is altered or removed. Apart from any warranty implied
by the law that cannot be excluded and the warranty specifically provided above, Divine Meditech Pvt Ltd (INDIA)
makes no warranty representation or covenant whatsoever in respect of the COLpro222DX-OZview or any part of the
COLpro222DX-OZview and all other warranties, representations, or covenants, express or implied, are hereby
excluded.
To obtain service under this warranty, first contact Divine Meditech Pvt Ltd (INDIA) (see details on front page).
Divine Meditech Pvt Ltd (INDIA) will correct any warranty failure by replacing the COLpro222DX-OZview or repairing
the COLpro222DX-OZview. Divine Meditech pvt ltd is limited to a liability to pay to the customer an amount equal to
the cost of replacing COLpro222DX-OZview, or the cost of having the COLpro222DX-OZview repaired, whichever is
the lowest amount.
To the fullest extent permitted by law, the customer will not under any circumstances have any cause of action
against or right to claim or recover from Divine Meditech Pvt Ltd (INDIA) for or in respect of any negligence or
economic loss of any special reliance, indirect or consequential loss, damage, or injury, including but not limited to,
loss, damage or injury in connection with an incorrect diagnosis arising out of or in connection with the use or supply
of the COLpro222DX-OZview or any part of it.
The customer expressly acknowledges and agrees that:
a.
The COLpro222DX-OZview is a technical medical device and it is the responsibility of the physician to
provide the final clinical diagnosis and treatment to the patient based on all information the physician has
available to him or her.
b.
The COLpro222DX-OZview is intended to assist the physician, not to provide a conclusive determination or
to serve as a substitute for the physician’s judgment with respect to the detection and treatment; and
All users of COLpro222DX-OZview shall be required to advise patients of the above limitations.
c.
By opening the packaging of the COLpro222DX-OZview, customers will be deemed to have read, fully understood
and accepted all of the above warranty terms and conditions. If the customer does not accept the above warranty
terms and conditions in their entirely, please contact Divine Meditech Pvt Ltd (INDIA).
Operator’s Manual Ver: DMPL-STD-222
- 12 -
COLpro222DX-OZview
COLpro222DX
-
OZview
(GIMA
29620)
Digital
Video
Colposcope
YYYY
-MM
www.gimaitaly.com
Pollution
Free-Disposal
BF application
component
Sec 9
LABELLING FORMAT FOR TRACEABILITY:
Divine Meditech Private Limited
G-197, Sector-63, Gautam Buddha NagarUttar
Pradesh – 201301 India
Made in India
Meddevices Lifesciences B.V.
Keizersgracht 482,
1017 EG Amsterdam, the Netherlands
Video Colposcopio Digitale
IMPORTATO DA / IMPORTED BY:
GIMA S.p.A.
Via Marconi, 1
20060 Gessate (MI) - Italy
Explanation of Symbol
Manufacturer
Authorized
representative in the
European Community
Attention/Be careful
Operator’s Manual Ver: DMPL-STD-222
Medical Device Compliant with Regulation (EU 2017/745)
- 13 -
Date of manufacture
Medical device
Please read the instruction
for use
COLpro222DX-OZview
Sec 10 CHECK LIST for ACCESSORIES for COLpro222DX-OZview
POWER CORD
SVHS CABLE
BNC CABLE
REMOTE CONTROL
SOFTWARE INSTALLATION CD AND USB DONGLE
KEY (LICENSE TO RUN THE SOFTWARE)
: PART OF SOFTWARE
SERIAL FOOT SWITCH
USB FOOTSWITCH WITH EXTENSION
CABLE(Optional)
: PART OF SOFTWARE
VIDEO CAPTURE CARD
: PART OF SOFTWARE
Warning: All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and competent authority of the
member state where your registered office is located.
CONTACT INFORMATION:
Divine Meditech Pvt Ltd.
G-197, Sector-63, Gautam Buddha Nagar
Uttar Pradesh, India-201301
Info@divinemeditech.in
Operator’s Manual Ver: DMPL-STD-222
- 14 -
COLpro222DX-OZview
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