Divine COLpro777 Full HD Digital Video Colposcope User Manual

Divine COLpro777 Full HD Digital Video Colposcope

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, or 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 before use. Failure to follow instructions or to heed warnings could lead to patient or operator injury. COLpro777-FullHD version is the 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.

DESCRIPTION

DESCRIPTION OF COLpro 777- Full HD

COLpro777-FullHD view is an aid to colposcopy. Colposcopy is a gynecological procedure in which the doctor, using a 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 the 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, the facility to vary the light intensity, facility to choose various colour 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 the cervix area. So far colposcopy plays a significant role in the 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. The operation must be performed per stipulated safety standards thus to ensure patient and operator safety.

GENERAL WARNINGS & PRECAUTIONS

Intended Use: For examination of the tissues of the vagina, cervix and external genitalia through 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

Symbols and Terminology

| Attention: Consult the 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 symbol 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.
The 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 users 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 the 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 the 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 the knob, the excessive force may damage the twin-axis adapter of the colposcope head.
• This is a non-contact type examination device, avoid contacting the patient during use.
• Before turning off the power supply of the whole system, never plug or unplug the video cable.
• Without written approval of the manufacturer, the 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.
• To prevent accidental power failure and other potential accidents, use an 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’s 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 a replacement of medical regulations.

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: A 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 a computer workstation to save, analyze print patient information etc. Its height can be adjusted according to actual needs.

External Cable of the interface box

• Use the accompanying power cord; insert one end into 1 of Figure B and the other end to a 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). Connect SVSH or Video Cable to standard video display or colposcopy Software.

ASSEMBLING STEPS

• STEP 1 Grasp the lower vertical pole “FIGURE A. 4.” and put it into the middle hole of the rolling base “FIGURE A. 6.”
• STEP 2 Screw in the nut “FIGURE A. 7.”
• STEP 3 Lie down the lower vertical pole “FIGURE A. 4.”, fix the nut “FIGURE A. 7.” by rotating it clockwise, thus to fix the rolling base “FIGURE A. 6.” and lower vertical pole “FIGURE A. 4.”
• STEP 4 Insert the camera head cable (grey) into the hole of the vertex plate adapter “FIGURE A. 1.”

Make sure to insert the camera head cable through the first hole of the vertex plate adaptor 1st and then the 2ndhole as shown in the reference picture.

• STEP 5 Push the cable through the upper vertical pole “FIGURE A. 3.” Until the cable comes out. Do not fix the camera on the axis adapter now. It can cause cable twisting.

• STEP 6 Connect the cable that 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 arrow markings pasted on the cables.

• 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 the cable, thus.

• STEP 8 Pull the hand grip of the vertex plate adaptor upside by 900, grasp the camera’s handle carefully and put the fixing base (which is attached to the camera head) into the vertex plate adaptor. When the camera head is attached, release the hand grip of vertex plate.

WARNING

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).

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).
The interface box has SVHS video output, BNC output, YPBPR output and DVI Output for connection to a suitable video device such as a medical-grade monitor. Switch ON the main power button provided on the camera head panel. The system is now ready for use.

CAMERA HEAD CONTROL PANEL – FUNCTIONS

• A. LED for Power
• B. On/Off Switch
• 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 colour contrast selector
• I. Zoom Out
• J. Zoom In
• K. Timer & Zoom Factor Display
• L. E-Flip
• M. Mirror Image

REMOTE CONTROL FUNCTIONS

• A. Gamma ON
• B. Gamma OFF
• C. Zoom IN
• D. Zoom OUT
• E. Pause
• F. 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

TECHNICAL SPECIFICATIONS

00 K

Test Timer| Yes
Electronic Green Filter| Yes
Focus| Automatic and Manual
Focus Distance| 30 – 40cm
Zoom| 1 – 45x
Viewing area| 170mm – 10mm
Depth of view| 200mm – 5mm
Magnification display| Yes
Video Output| Full HD: Component Y Pb Pr DVI

Standard Video: SVSH / Video

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

LIST OF REPLACEMENT PARTS

SYSTEM MAINTENANCE

Cleaning Agent: Examples of disinfectants that can be used on the colposcope unit are listed below:

1. Dilute Sodium Hypochlorite (Bleaching Agent)
2. Diluted Formaldehyde 35%-37%
3. Hydrogen peroxide 3%
4. Alcohol 75%
5. Isopropanol 70%

The Digital Video colposcope can be cleaned with hospital-grade ethanol and dried in air or with a crisp and clean cloth.

Cleaning Steps

• Turn off the camera & colposcope, and cut the connection with the AC power supply.
• Clean external parts and stand
• Clean connecting cables.
• Wipe all the cleaned parts with a dry cloth.

Warnings

• The 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 an abrasive material to clean any part of the Colposcope.
• Do not use strong solvents to clean any part of the 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 a colposcope

• Examine whether there is any mechanical damage
• Examine all external cables, and 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 the 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 the plug and cable, and that all the pins and plugs are not loose.
• Check whether the connection between the vertical stand, monitor & camera is correct & unbroken.
• Check there is no cable breakage by moving each end of the cable.

Camera Head Maintenance

• The camera head is an important part of the colposcope, dust particles can accumulate on it and may affect colposcope performance, if the fingerprint is left on the camera lens it could lower the image quality and it is harmful to the camera lens coating, so it should be removed/cleaned quickly.
• Use a soft brush to clean the camera.
• Put a drop of camera lens rinse solution on cotton paper, then use it to wipe the camera surface.

Maintenance of unit

• Do not attempt to immerse any part of the equipment in cleaning solutions.
• Do not use an abrasive material to clean any part of the Colposcope.
• Do not use strong solvents to clean any part of the Colposcope.
• Do not leave any solution residue on the device, if so, please wipe it off quickly with a cloth damped in water.

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 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 worldwide from us or the Dealer or Agent.
• This warranty shall not cover damage malfunction or failure resulting from the use of COLpro777-FullHD other than per 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 the 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 liability to pay 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:

• 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.
• 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 of the detection and treatment; and
• All users of COLpro777-FullHD shall be required to advise patients of the above limitations.

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).

LABELLING FORMAT FOR TRACEABILITY

www.gimaitaly.com

Explanation of Symbol

CHECKLIST for ACCESSORIES for COLpro777-FullHD

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.

Divine Meditech Pvt Ltd

• G-197, Sector-63, Gautam Buddha Nagar
• Uttar Pradesh, India-201301

Med devices Lifesciences

• B.V.Keizersgracht 482,
• 1017 EG Amsterdam, the Netherlands

Imported by:

• GIMA S.p.A
• Via Marconi, 1 – 20060 Gessate (MI) Italy
• gima@gimaitaly.com – export@gimaitaly.com
• www.gimaitaly.com.

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