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 COLpro777-FullHD 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. COLpro777-FullHD version is our newest, most advanced and recently upgraded
model of our COLpro777-FullHD series. Many additional facilities have been added according to the feedback
received from various users and stakeholders of our widely acclaimed COLpro777-FullHD series. The Delivered
Product may vary slightly in color or shape or specifications due to continuous product development.
Sec 2 DESCRIPTION OF COLpro 777- Full HD
COLpro777-FullHD view 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, 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.
COLpro777-FullHD 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 COLpro777-FullHD
view. 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: For examination of the tissues of the vagina, cervix and external genitalia by means of
magnification 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-FHD-777
2 -
COLpro777-Full HD
Page 3
Symbols and Terminology:
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
WARNINGS
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 conjunction 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 the eye.
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: The safety requirement mentioned in this section is for Colposcope as a whole and
applies 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. When not in use, the colposcope power supply shall be turned off, and the camera shall be covered to
prevent dust.
Operator’s Manual Ver: DMPL-FHD-777
3 -
COLpro777-Full HD
Page 4
DVI
Full HD
output
Y Pb Pr
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 DIRECTIONS FOR USE
COLpro777-FullHD 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 Stand Composition: Vertical stand with interface box can be 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.
External Cable of interface box
Use accompanying power cord; insert one end into 1 of figure B and the other end to grounded power
outlet.
Connect one end of Y Pb Pr HD Video Cable to fig B full HD output and the other end to an external HD
display monitor (with Y Pb Pr). And Connect SVSH or Video Cable to standard video display or
colposcopy Software.
COLpro777Full HD
twin axis adapter
1.
2.
Knob
vertical pole (upper)
3.
4.
vertical pole (lower)
5.
Interface Box
6.
Fig. A. Vertical stand
Interface Box Composition
rolling base
nut
7.
Fig. B Interface Box
SVHS
BNC
AC socket
Operator’s Manual Ver: DMPL-FHD-777
4 -
COLpro777-Full HD
Page 5
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.”
Fig. C - Step 1 Fig. D - 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
Fig. E - Step 3
Make sure to insert the camera head cable through Reference picture for Step 4
the first hole of vertex plate adaptor 1
2ndhole as shown in the reference picture.
Operator’s Manual Ver: DMPL-FHD-777
st
and then
5 -
COLpro777-Full HD
Page 6
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.
Fig. G - Step 5
Fig. H - 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.
Fig. I - Step 7
Operator’s Manual Ver: DMPL-FHD-777
6 -
COLpro777-Full HD
Page 7
STEP 8 Pull the hand grip of vertex plate
WARNING
KNOB
1
KNOB
2
KNOB
3
colposcope head.
adaptorutside 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.
1. Lose KNOB 1 to tilt the camera
head.
2. Lose KNOB 2 to move the camera
head sidewise (left-right).
3. Lose KNOB 3 to adjust the height
of the camera head (up-down).
Without losing knobs, the excessive
force may damage twin axis adapter of
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, YPBPR output and DVI 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-FHD-777
7 -
COLpro777-Full HD
Page 8
M
A
H
F
G
CAMERA HEAD CONTROL PANEL – FUNCTIONS
A. LED for Power
B. On/Off Switch
L
B
K
C
J
I
◦ LED for Power
LED next to the ON/OFF Switch lights up, when power is ON from
ON/OFF switch (B)
D
E
C. LED for Auto Focus
D. Auto Focus
E. Intensity Variation /
Manual Focus
F. Pause or freeze
G. Green Filter On
H. Green Filter Off and color
contrast selector
I. Zoom Out
J. Zoom In
K. Timer & Zoom Factor Display
L. E-Flip
M. Mirror Image
ON/OFF Switch Press once to get the device camera and illuminator ON & if pressed
◦ LED for Auto Focus
Auto Focus
Intensity Variation
Pause or Freeze This button allows you to freeze the required image that needs to be
Green Filter ON
Green Filter OFF and
color contrast selector
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.
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 5 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 G5 on screen.
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
Operator’s Manual Ver: DMPL-FHD-777
8 -
COLpro777-Full HD
Page 9
A B
D
E
I
K
Zoom
-
Out Press
this button
to
close
the Zoom in
factor
Zoom
- In
E-Flip
Mirror
-
Image
Mirror
Image
gives
a
side view of the
image
for better
diagnosis.
This button allows zooming of the image up to a certain level where one
Timer & Zoom factor
display
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.
REMOTE CONTROL FUNCTIONS
G
C
F
J
H
A. Gamma ON
B. Gamma OFF
C. Zoom IN
D. Zoom OUT
E. Pause
Green Filter ON
F.
G. Green Filter OFF
H. Manual Focus
I. Auto Focus
J. Timer & Zoom Factor Display
K. Mirror Image
L. E-Flip
L
Operator’s Manual Ver: DMPL-FHD-777
9 -
COLpro777-Full HD
Page 10
o
Sec 5 TECHNICAL SPECIFICATIONS
Image Processor
Pixels > 200,000
Resolution Full HD 1920 x 1080
E-Flip Yes
Mirror Image Yes
Electronic Shutter Automatic
Signal to noise ratio: > 50 db
Illumination
SONY Color CCD
High MCD super bright white shadow less LED light
Color Temperature
Test Timer Yes
Electronic Green Filter Yes
Focus Automatic and Manual
Focus Distance 30 – 40cm
Zoom 1 – 45x
Viewing area
Depth of view
Magnification display Yes
Video Output Full HD: Component Y Pb Pr
Safety Standard Complies to IEC 60601 including EMC
Gamma Processor Optional (through remote)
Remote access (optional) - for operative functions
Power Supply 100-240 VAC, 50/60 HZ
7000 K
170mm – 10mm
200mm – 5mm
DVI
Standard Video: SVSH / Video
Operator’s Manual Ver: DMPL-FHD-777
10 -
COLpro777-Full HD
Page 11
Sl No Part Description
Remark
Australia
Europe
Sec 6 LIST OF REPLACEMENT PARTS
1
Head Cabinet
2
Metallic Housing of Camera
3
Illuminator
4
Micro Controller Unit
5
Cable Assembly
6
Interface Panel
7
Stand with vertex
8
HD Camera Module
9
Y Pb Pr Cable
10 SVSH Cable
11 BNC Cable
12 Power Cord
South Africa & India
13 Multiple volt power supply
14 DVI Cable
Operator’s Manual Ver: DMPL-FHD-777
11 -
COLpro777-Full HD
Page 12
Sec 7 SYSTEM MAINTENANCE
Cleaning Agent: Examples of disinfectants that can be used on the colposcope unit are listed below:
1.
Dilute Sodium Hypoclorite (Bleaching Agent)
2.
Diluted Formaldehyde 35%-37%
Hydrogen peroxide 3%
3.
4.
Alcohol 75%
5.
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-FHD-777
12 -
COLpro777-Full HD
Page 13
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 COLpro777-FullHD 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 COLpro777-FullHD 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 COLpro777-FullHD 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 COLpro777- Full HD or any
part of the COLpro777-FullHD 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 COLpro777-FullHD or repairing
the COLpro777-FullHD. Divine Meditech Pvt Ltd to a liability to pay to the customer an amount equal to the cost
of replacing COLpro777-FullHD, or the cost of having the COLpro777-FullHD 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 COLpro777-FullHD or any part of it.
The customer expressly acknowledges and agrees that:
a.
The COLpro777-FullHD 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 COLpro777-FullHD 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 COLpro777-FullHD shall be required to advise patients of the above limitations.
c.
By opening the packaging of the COLpro777-FullHD, 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-FHD-777
13 -
COLpro777-Full HD
Page 14
Divine
Meditech
Private
Limited
Digital
Video
Colposcope
-
Full HD
YYYY MM
www.gimaitaly.com
Sec 9 LABELLING FORMAT FOR TRACEABILITY:
Pollution
Free
-
Disposal
BF application
component
G-197, Sector-63, Gautam Buddha Nagar
Uttar Pradesh – 201301 India
Made in India
Meddevices Lifesciences B.V.
Keizersgracht 482,
1017 EG Amsterdam, the Netherlands
COLpro777Full-HD (GIMA 29622)
Video Colposcopio Digitale - Full HD
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
Date of manufacture
Medical device
Please read the instruction
for use
Medical Device Compliant with Regulation (EU 2017/745)
Operator’s Manual Ver: DMPL-FHD-777
14 -
COLpro777-Full HD
Page 15
Sec 10 CHECK LIST for ACCESSORIES for COLpro777-FullHD
POWER CORD
SVHS CABLE
BNC CABLE
YPBPR CABLE
DVI CABLE
REMOTE CONTROL
SOFTWARE INSTALLATION CD AND USB DONGLE KEY
(LICENSE TO RUN THE SOFTWARE)
: PART OF SOFTWARE
USB FOOTSWITCH WITH EXTENSION CABLE
: PART OF SOFTWARE
VIDEO CAPTURE CARD
: PART OF SOFTWARE
Operator’s Manual Ver: DMPL-FHD-777
15 -
COLpro777-Full HD
Page 16
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.