2200I 2200I (H) User Manual V1.0F

Colposcope System user’s manual
Preface
Dear users,
First of all, thank you for your trust to choose our colposcope digital
imaging system!
To help you get familiar with the product as soon as possible, we provide a
detailed user manual along with the instrument. When you first install and use
the instrument, please read all the attached data carefully!
To meet the market and customer demands, the Company will
continuously improve quality and performance of the product. We will try to
keep you informed of the latest improvements to the product in a timely
manner. Your corrections are eagerly welcomed if there is any error and
omission in the User Manual!
The contents of the Manual are protected by copyright law. All rights
reserved. No part of the Manual may be reproduced, photographed, copied or
translated into other languages without prior written permission of the
Company.
● Contact information:
Company Name: Xuzhou Kernel Medical Equipment Co., Ltd.
Company Address: Kernel Mansion, Economic Development District, Xuzhou City,
Jiangsu Province, China Zip Code: 221004
Tel：+86(516)87732209 Fax: +86(516)87732210
Web: www.kernelmed.com Email: [email protected]
Edition： V1.0F
Instructions to Users
In case of any problem or in need of help during use, please contact
Technical Service Center of the Company. We will offer solutions as soon as
possible or send professionals for service.
Proper use can extend service life of the instrument, so as to maximize
its use value.
While improper use may cause harm to the instrument or workers. The
Company will neither assume any liability for any harm to the people or
instrument due to violations against provisions of the Manual, nor for reduced
performance indexes therefrom, such as instrument performance, reliability
and safety, nor offer free maintenance for such faults!
Please carefully read in the "safety requirements" and

"precautions".
Table of Content
CHAPTER I SAFETY REQUIREMENTS AND PRECAUTIONS .................................................. 1
1.1 CONTRAINDICATIONS .................................................................................................................. 1

1.2 WARNINGS .................................................................................................................................. 1
1.3 PRECAUTIONS .............................................................................................................................. 2
1.4 NOTE ........................................................................................................................................... 4
CHAPTER II OVERVIEW ................................................................................................................. 6
2.1 FUNCTION OVERVIEW .................................................................................................................. 6

2.2 STRUCTURE COMPOSITION ........................................................................................................... 8
2.3 MAIN TECHNICAL PARAMETERS ................................................................................................... 8
2.4 DESCRIPTION OF MARKINGS ....................................................................................................... 10
CHAPTER III INSTALLATION AND CONNECTION ................................................................... 11
3.1 PRE-INSTALLATION CHECK ........................................................................................................ 11

3.2 CONNECTION ............................................................................................................................. 11
CHAPTER IV SUGGESTED CLINICAL OPERATIONS ............................................................. 12
4.1 APPARATUS AND REAGENTS FOR EXAMINATION ......................................................................... 12

4.2INSTRUMENT OPERATION STEPS AND PRECAUTIONS ..................................................................... 12
CHAPTER V OPERATION AND USE OF THE SYSTEM ........................................................... 13
5.1 OPENING AND CLOSING OF THE SYSTEM ..................................................................................... 13

5.2 OPERATION OF THE CAMERA DEVICE .......................................................................................... 14
5.3 OPERATION OF CONTROLLER ...................................................................................................... 14
5.4 SOFTWARE OPERATION .............................................................................................................. 15
CHAPTER XI MAINTENANCE ...................................................................................................... 16
6.1 MAINTENANCE OF THE INSTRUMENT AND ITS ACCESSORIES ........................................................ 16

6.2 CLEANING OF THE INSTRUMENT ................................................................................................. 16
6.3 STORAGE ................................................................................................................................... 17
6.4 TRANSPORTATION AND STORAGE ................................................................................................ 17
6.5 REPLACEMENT OF BATTERY ....................................................................................................... 18
6.6 CHARGE OF BATTERY ................................................................................................................. 19
CHAPTER VII COMMON FAULTS AND CAUSES...................................................................... 20
CHAPTER VIII AFTER-SALES SERVICE .................................................................................... 22
APPENDIX A ASSEMBLY OF CANTILEVER SUPPORT .......................................................... 23
APPENDIX B ASSEMBLY OF CART ........................................................................................... 25
APPENDIX C INSTALLATION OF CAMERA DEVICE ............................................................... 28
APPENDIX D DECLARATION OF THE EUT ............................................................................... 29

Chapter I Safety Requirements and Precautions
(Please read this chapter carefully before use of the instrument!)
 Contraindications - The equipment is absolutely forbidden for use under such

circumstances.
 Warnings——used to identify a hazard that may lead to death or serious injury.
 Precautions——used to identify a hazard that may result in minor or moderate
injury to the user or patient or damage to the equipment or other property.
 Note - General precautions.
1.1 Contraindications
 It is forbidden to perform vaginal operations, such as gynecological examinations,

one day before the colposcope examination.
 It is forbidden to take vaginal administration two days before the colposcope
examination.
 It is forbidden to have colposcope examination during the menstrual period.
1.2 Warnings
 The electromagnetic field is likely to have interference on normal work of the

instrument. Therefore, the equipment to be used nearby the instrument must
comply with EMC requirements. X-ray generator or magnetic resonance
equipment is the potential interference source, as they may produce
electromagnetic radiations of high intensity. Besides, it is important to get away
from the mobile phone or other communication equipment.
 Do not open shell of the instrument without permission, otherwise you may have
an electric shock hazard. Any maintenance or upgrade of the instrument must be
conducted by the maintainers trained or authorized by the Company.
 The instrument can only be used in the occasions specified by well-trained
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medical staff. Any personnel unauthorized or untrained will not be allowed to

conduct any operation to the instrument.
 To prevent electric shock and reduce system fault, the instrument should not be
exposed to water. If the system is exposed to water accidentally, please stop it
immediately, and send it to professionals for repair before using again.
 Closing the main machine in an improper way may affect normal use of its
software system, or even damage software functions of the system.
 It should not be used in an environment containing inflammables/explosives
such as anesthetics, so as to prevent fire or explosion.
1.3 Precautions
 Before using the instrument, please strictly confirm the indications,

contraindications and possible adverse reactions.
 To ensure safety and accuracy of the equipment, only accessories with the
specifications specified by the Company can be used. The specifications of the
camera device adapter: GM 18-120150-1; input: 100-240 V, 50/60 Hz, 0.8 A;
output:12 VDC, 1.5 A.
 Other equipment to be connected with the instrument should comply with the
requirements in IEC 60950-1/IEC 60601-1.
 Cervical cancer smear, cleanliness and trichomonad/mold checks should be
completed in general outpatient clinics in advance.
 The colposcope examination is only a supplementary means, and its results are
not necessarily the final ones, which should be judged in combination with other
examination methods for final determination of the cause.
 Before use of the instrument, it is required to carefully check the instrument and
its connection cables and accessories, so as to ensure their normal and safe
operation.
 During using the instrument, get as far as possible away from radio frequency
lines, such as audio or video sources.
 Avoid using the camera device for image capture of high-brightness objects,
such as high-brightness light source, the sun, etc.
 The colposcope lens is a kind of precision optical instrument, and any falling to
the ground/collision may cause damage to the lens or deviation of the optical
axis, and further lead to unclear images that cannot be used.
 Closing the main machine in an improper way may affect normal use of its
software system, or even damage software functions of the system.
 Portable multiperture socket should not be placed on the ground, and its
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maximum load capacity is AC 10 A/250 V.

 The portable multiperture socket can only supply power to the equipment within
this system, and should not be connected to any equipment other than the
system components. If it is connected with other electrical equipment or devices
randomly, it may cause safety hazards for some reasons, such as superposition
of leakage current.
 Other additional multiperture sockets or extensions may not be connected to this
system.
 To ensure safe operation of the instrument, the various replaceable parts,
accessories and consumables to be equipped for the instrument should be
products with the specifications specified by the Company.
 The instrument must be connected to a separate power socket instead of sharing
one with other electrical equipment. In case of excessive mains voltage
fluctuations, it is required to equip AC stabilified-voltage power supply with
accuracy of 2%.
 The instrument should be placed in a stable place. If there is no need for
movement, please fasten the caster brake.
 The electrical equipment not specified in the Manual should not be connected
with the instrument.
 Reserve enough space around the instrument, so as to ensure normal ventilation
of the instrument.
 Ensure normal working environment and power supply requirements during
operation of the instrument.
 The replaced batteries should be disposed according to relevant provisions on
waste electronic products instead of being discarded randomly, so as to avoid
pollution to the environment.
 It is forbidden to immense the batteries in water, and during standby, they should
be placed in a cool and dry environment;
 It is forbidden to use or place the batteries besides high temperature heat
sources (e.g. fire and heater);
 It is forbidden to use the battery with the positive and negative electrodes
reversed;
 Please use special lithium battery charger for charge;
 It is forbidden to throw the batteries into fire or heater;
 It is forbidden to transport or store the batteries together with metals, such as
hairpins, necklaces, etc.;
 It is forbidden to knock, throw or stamp on the batteries, etc.;
 It is forbidden to weld the batteries directly;
 It is forbidden to pierce the batteries with nails or other sharp objects.
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 Disposal of the system and accessories

The packaging materials should be disposed according to the locally used waste
disposal regulations, so as to protect children from them.
The instrument has a service life and a shelf life of respectively five years. After
the end of life, the instrument and its accessories should be disposed according to
relevant laws and regulations for disposal of such products. In case of any doubt
about the disposal, please contact the Company or corresponding agency.
 User Manual
To ensure continuous and safe use of the instrument, the user must comply with
the instructions listed. However, these instructions can never replace the accepted
medical practice experience about patient care.
Please place the Manual nearby the instrument, so that it can be easily accessed
in a timely manner when needed.
1.4 Note
 Precautions for colposcopy examination

1. Avoid using lubricant when placing the vaginal dilator.
2. The vaginal dilator should be placed from the orthophoria lower dilated edge to
avoid scratching the cervix.
3. The optimal function time of 3% acetic acid test is 10-20 s.
4. The iodine test can help the beginners to avoid missed diagnosis.
5. Fully expose the cervical canal to avoid missed diagnosis.
6. Do not ignore those subject to ingression of transformation zone.
7. Selection of operation time:
 There is no time restriction for suspected cervical cancer or precancerous
lesions;
 The cervical canals should be examined for lesions nearby or during
ovulatory period;
 Other diseases should be examined within two weeks after menstrual
period.
 The "encryption dog" should be properly kept, not damaged or lost. If the
"encryption dog" is not inserted, the system can only implement demonstration.
 The power supply should be turn off first, and the AC power supply cut off before
cleaning of the instrument.
 Do not pour the liquid on the instrument while cleaning, and ensure no ingression
of any liquid into the instrument.
 Do not drop the cleaning fluid directly on the lens.
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 As the lens has surface coating, the time for every cleaning should not be more
than 30 s, and the lens should not be pressed or rubbed hard.
 If the battery is subject to obvious damage or run out of capacity, it should be
replaced.
 Only the battery with the specifications specified by manufacturer can be used
for replacement, i.e. L50 AC 193 A 7.2 V, 2.2 Ah.
 The battery replacement, requiring no professional, can be completed by the
user according to the method specified in Section 6.5.
 Before the battery replacement, it is required to first turn off power supply of the
camera device and disconnect the control line.
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Chapter II Overview
KN-2200 series colposcope digital imaging system combines digital imaging

technology and colposcope technology and applies to the clinical gynecologic
examination of such parts as vulva, vagina, cervix, etc. It breaks through the limitations of
optical colposcope by eliminating the use of eyepieces and enables doctors to observe
the focus on color display. With highly magnified images, it is capable of identifying tiny
details and realizes integrated management of the images observed on screen including
capture, magnification, freeze, storage, pathological analysis and printing, finally providing
better services for both doctors and patients in diagnostic process. The product
maximizes the functions of colposcopy and better satisfies the future development needs
of "digital" medical imaging.
2.1 Function overview
Application scope
For clinical examination of such parts as vulva, vagina, cervical, etc.
Features of the instrument
 Use of high resolution and high definition color digital camera device
 High resolution color digital camera device
 KN-2200I(H) is subject to high definition digital video camera, which has
effective pixels up to 32,700, and applies high definition monitor and
capture card that yield higher image quality and thus more accurate clinical
diagnosis.
 KN-2200I supports video output; (KN-2200I(H) supports HD-SDI output).
 Fast auto and manual focus control.
 Automatic white balance adjustment.
 KN-2200I supports two power supply modes: external AC and built-in
batteries (KN-2200I(H) does not support power supply by batteries).
 Unique light source design scheme
 Use of energy saving and environmentally friendly LED light source for
lighting, so that the brightness can be adjusted freely.
 Combined cart
6
 Brand new combined cart, which is flexible, convenient and space-saving.

 Two types of cart, which can meet different user needs.
 Integrated damping cantilever support, which can easily stay at any height.
 Potable multiperture socket, which can be fixed on the cart, so as to avoid
such hazards as forced dragging or accidental ingression of water.
 Foot switch
 Unique foot switch design, which makes imaging more convenient and
flexible.
 Controller
 Use of controller design, which enables the user to use handle for such
adjustment operations as enlargement, reduction, far focusing and near
focusing of images when mouse operation is not allowed.
 Integration of computer imaging, data management and condition analysis
functions
 It supports text in multiple languages, including Chinese, English, Spanish,
Russian, Vietnamese and Turkish.
 Multi-functional management software, which is integrated with image
observation, capture, videorecording, freeze, editing and report printing
and storage functions.
 Special software package, which can implement such operations as
tagging, adding annotations, magnification, reduction and local
magnification. Acetic acid reaction timing, which is applicable to dynamic
observation in colposcopy examination and surgery.
 Built-in standard case report template, which is convenient for editing and
printing case reports, supports printout of diagnostic reports and true color
images in multiple formats, and allows the doctor to design the case report
by itself.
 It allows querying cases in three modes: by case No., name and
examination date. It supports image display, data modification, saving,
follow-up diagnosis and video replay of the retrieved cases.
 It can store a large amount of image data, and has backup function.
 It supports one-click installation, and operating systems higher than WIN7.
 Rear LCD (optional for KN-2200I)
 The camera device can be optionally equipped with 2.5-inch LCD monitor
to implement real-time observation of dynamic images.
 Wireless transmission function (optional for KN-2200I)
 It can be optionally equipped with image wireless transmission function to
implement consultation and teaching functions of all scales.
 Bar code gun (optional)
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 It is optionally equipped with bar code gun function to facilitate fast creation
and search of cases.
2.2 Structure composition

Camera device Camera device
with LED light with LED light
source source
Rear LCD
Controller
Controller
Support Cart
KN-2200Ⅰ KN-2200Ⅰ(H)
Figure 2-1
KN-2200I is a kind of standard definition camera device, while KN-2200I(H) a high
definition one.
2.3 Main technical parameters
 Operation mode: Continuous operation.

 Ordinary equipment (do not prevent ingression of liquid)
 Equipment that cannot be used in the presence of flammable anesthetizing
gas mixed with air, or oxygen or nitrous oxide.
 Auxiliary display: Resolution ≥ 320 x 240 pixels.
 Power supply type: DC 12 V, 1.5 A.
 KN-2200I lithium battery: 7.4 V, 2.2 Ah;
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 Camera device:
 KN-2200I: Horizontal resolution of 550 lines; color digital CCD, automatic
focus control, and minimum illumination: 0.8 Lux (F1.2); PLA standard pixel
of 440,000; NTSC standard pixel of 380,000; magnification of 216 times.
 KN-2200I(H): Horizontal resolution of 1,000 lines; automatic focus control,
and minimum illumination: 1.7 Lux (F1.6, when ICR is closed); pixel of
3,270,000; magnification of 240 times.
 The instrument has no application part.
 The instrument has no signal input/output part.
 Working environment:
 Temperature：5～40℃
 Relative humidity：≤85%
 Atmospheric pressure：700hPa～1060hPa
 Computer configuration:
 Dual-core CPU of 2.4 GHz or higher
 Memory of not less than 2 G
 Space of the hard disk for software installation of not less than 100 G
 The mainboard has PCI-E slot, and the high definition products should
have HDMI.
 Monitor: with hanging holes
 KN-2200I: with resolution of not less than 1,440*900 pixels;
 KN-2200I(H): with resolution of not less than 1,440*900 pixels; 1080P,
with HDMI or DP high definition interface
 Printer: Supporting color printing, with resolution of not less than 600×600
pixels.
 Software: Supporting operating system higher than WINDOWS 7.
 Movable support: The support can be adjusted up and down, and the upper
cradle head part can be manually adjusted for 360 degrees;
 Light source:
 Illumination: The light source luminance can be adjusted. Within the
working distance, the illumination is not less than 1,200 Lux.
 The illuminated surface temperature is not above 41°C.
 Working distance: The camera device is 200~400 mm apart from the part to
be examined, and its focus should be adjusted so that clear images can be
observed on the monitor.
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2.4 Description of markings
Note! Refer to the attached files (user's manual, installation and operation
manual and packing list)
Waste disposal marking
Refer to user’s manual
Production date
IPX1 Drip-proof equipment
Turn on/off the LED light source
Enhance luminance of the LED light source. Every press will increase the
luminance by one level.
Reduce luminance of the LED light source. Every press will reduce the
luminance by one level.
Enhance red light of the image
Reduce red light of the image
Magnify the image being observed
Reduce the image being observed
Adjust the focus farther
Adjust the focus nearer
White balance
Freeze
10
Chapter III Installation and Connection
3.1 Pre-installation check
 Take the instrument out of the packing case, place it at a safe and stable position
for observation, and fasten the universal wheel at the bottom of the cart.
 Check the attached accessories according to the packing list, so as to ensure
completeness of the accessories.
3.2 Connection
3.2.1 Assembly of cantilever support

Please refer to Appendix A.
3.2.2 Assembly of cart

Please refer to Appendix B.
3.2.3 Assembly of camera device

Please refer to Appendix C.
3.2.4 Hardware connection and software installation

Please refer to the installation and operation manual.
3.2.5 Power connection

The camera device can only be connected to the adapter or power output device
with output voltage of DC 12 V and current of equal to or greater than 800 mA, and
complying with IEC60601-1 or IEC60950.
Precautions:
-The instrument must be connected to a separate power socket instead of sharing one
with other electrical equipment. In case of excessive mains voltage fluctuations, it is
required to equip AC stabilified-voltage power supply with accuracy of 2%.
-The electrical equipment not specified in the Manual should not be connected with the
instrument.
-The instrument should be placed in a stable place. If there is no need for movement,
please fasten the caster brake.
-Reserve enough space around the instrument, so as to ensure normal ventilation of the
instrument.
-Ensure normal working environment and power supply requirements during operation of
the instrument.
11
Chapter IV Suggested Clinical Operations
4.1 Apparatus and reagents for examination

1. Apparatus: Speculum, biopsy forceps, curet, gauze pliers, wire retractor, yarn ball,
cotton swabs, etc.
2. Reagents: 3% acetic acid solution and 1% iodine solution.
4.2Instrument operation steps and precautions

 Instrument operation steps (e.g. cervical examination)
Ask the patient to lie in bladder lithotomy position, place the vaginal dilator, and then
gently wipe mucus on surface of the cervix with sterile cotton balls. Adjust the distance
between the camera device and the examination positions (20~40 cm), and then adjust
focus of the colposcope to expose changes of the examination positions gradually, i.e.
transformation zone, epithelium and blood vessels.
During examination, apply 3% acetic acid solution on surface of the cervix, under
whose action the columnar epithelium will become edematous and slightly white to
botryoidalis, while squamous epithelium will become slightly white without change into
botryoidalis, which is the distinction therebetween. After the acid test, apply 1% iodine
solution evenly on surface of the cervix conventionally, with which the columnar
epithelium is not dyed, while the original squamous epithelium will be dyed dark brown,
and metaplastic squamous epithelium in different shades depending on maturity of
metaplasia. To observe more clearly morphologic changes of blood vessels, green filter
can be used for examination. Besides, under the action of acetic acid, normal blood
vessels will constrict, while abnormal blood vessels have no such change, which is the
distinction to help identify nature of the blood vessels.
 Precautions for colposcopy examination
1. Avoid using lubricant when placing the vaginal dilator.
2. The vaginal dilator should be placed from the orthophoria lower dilated edge to avoid
scratching the cervix.
3. The optimal function time of 3% acetic acid test is 10-20 s.
4. The iodine test can help the beginners to avoid missed diagnosis.
5. Fully expose the cervical canal to avoid missed diagnosis.
6. Do not ignore those subject to ingression of transformation zone.
7. Selection of operation time:
 There is no time restriction for suspected cervical cancer or precancerous lesions;
 The cervical canals should be examined for lesions nearby or during ovulatory
period;
 Other diseases should be examined within two weeks after menstrual period.
12
Chapter V Operation and Use of the System
5.1 Opening and closing of the system
 Opening of the system
1. Turn on switch of the portable multiperture socket;

2. Turn on power switch of the monitor;
3. Turn on switch of the camera device;
4. Press on-off key of the computer;
5. Insert the attached "encryption dog" into USB interface of the computer
6. Enter the WINDOWS operating system to have the icon pop up on the
desktop, and then double-click it to enter the system interface.
 Closing of the system

1. Log out from the colposcope digital imaging system, and close the
WINDOWS operating system;
2. Turn off power supply of the monitor;
3. Turn off switch of the portable multiperture socket.
Precautions: Closing the main machine in an improper way may affect normal
use of its software system, or even damage software functions of the system.
Note: The "encryption dog" should be properly kept, not damaged or lost. If the
"encryption dog" is not inserted, the system can only implement demonstration.
 Lens dust cover
Figure 5-1
While using, open the lens dust cover, and after using, close it to avoid
contamination or damage to the lens.
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5.2 Operation of the camera device
The operation panel of the camera device is as shown in the figure below:
Charging
indicator
Image Image
magnification reduction
Power
switch
Figure 5-2
 Charging indicator: Yellow means charging, and blue means charging
completed.
 Image magnification and reduction: Control magnification and reduction of
images.
 Power switch: Press the switch for 2 s to open or close the camera device. To
open the camera device, blue light will be emitted when pressing the button,
while to close it, no light will be emitted.
5.3 Operation of controller
The controller is used to control the LED light source and the image capture of
camera device.
Red light enhancement
Focus far Focus near
White balance
Red light reduction
Image reduction Image magnification
LED luminance reduction LED luminance enhancement

Opening and closing of
LED light source
Freeze
Figure 5-3 Controller Panel
 Control of LED light source
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 Open/close the LED light source.
 Enhance luminance of the LED light source. Every press will increase
the luminance by one level.
 Reduce luminance of the LED light source. Every press will reduce
the luminance by one level.
 Control of image capture:

 Enhance red light of the image.
 Reduce red light of the image
 Magnify the image being observed.
 Reduce the image being observed.
 Adjust the focus farther.

 Adjust the focus nearer.
 Automatic white balance. Press the button to adjust white balance of
the camera automatically.

 Freeze.
Note: Do not pull the connecting line hard when using the control handle in order
to avoid damage.
5.4 Software operation
Please refer to the installation manual.
15
Chapter XI Maintenance
To ensure normal operation of the instrument, and prolong its service life, it is
required to pay attention to maintenance of the instrument.
6.1 Maintenance of the instrument and its accessories
To ensure normal and safe work of the system, preventive inspection (including
performance inspection and safety inspection) and maintenance should be conducted
for the instrument and its accessories once every six months to confirm that the
instrument can work normally and is in good working condition, and that it is safe for the
medical staff and patients, with accuracy up to the level required for clinical applications.
1. Ensure that the instrument is reliably grounded.
2. Pay attention to the local grid voltage fluctuation, and if it falls beyond the allowable
range, add voltage stabilizing equipment as suggested.
3. It is not allowed to open shell of the instrument without permission, so as to avoid
affecting its normal use due to undue fault.
4. The accessories equipped for the instrument should be handled with care to avoid
drop, impact or pull, and they should not be wiped with corrosive chemicals!
5. The accessories should be stored together with the instrument, so as to decrease the
insertion and extraction times to extend its service life.
6. The camera device should be placed in a clean, dust-free and stable place. The
anti-shock of lens should be strictly managed. The Company will not guarantee repair
for fault of the lens due to drop.
7. When not in use, the camera device should be held in rigid packaging box to avoid
collision.
8. The equipment and accessories should be inspected regularly according to the check
cycle specified by the hospital. At the check cycle time, please contact the
manufacturer. It is advised that the user should inspect conditions of the equipment
and accessories during daily operation and use, so as to take corresponding actions,
and conduct comprehensive technical inspection on them every half a year, so as to
detect mechanical and cable damage.
9. The instrument shall be subject to regular maintenance in accordance with relevant
provisions of the hospital.
10. Upon expiration of the service life, the instrument and accessories should be
disposed correspondingly according to relevant provisions on waste electronic
products.
6.2 Cleaning of the instrument
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6.2.1 Equipment
Note: The power supply should be turn off first, and the AC power supply cut off
before cleaning of the instrument.
1. The most commonly used hospital cleaning solutions and non-corrosive detergents
can be used for cleaning the instrument, but it is important to note that many
detergents must be diluted prior to use. Please follow instructions of the detergent
manufacturer for use.
2. Avoid using ethanol, amine or acetone-based detergents.
3. The shell and screen of the instrument should be kept from dust pollution, and can be
wiped with a lint-free soft cloth or a sponge wet with detergents.
Note: Do not pour the liquid on the instrument while cleaning, and ensure no
ingression of any liquid into the instrument.
4. It is forbidden to use abrasives, such as steel wire brush or metal polishing agent, as
these materials may cause damage to the instrument panel and display screen.
5. When patch plug of the cable is occasionally wet, rinse it with distilled or deionized
water, and then dry it under 40-80°C for at least one hour.
6.2.2 Camera device
1. When cleaning the camera device, please do not use corrosive or abrasive
detergents. In the presence of dust, please use a dry cloth for cleaning. In case of
severe dirt, use neutral detergent to wipe it gently.
2. When cleaning the lens face, please do not use powerful or abrasive detergent. First
use a soft brush and blowing balloons to remove dust particles, then drip a small drop
of lens cleaning solution on the lens cloth or paper, gently wipe the lens surface, and
then wipe the lens with a clean cotton cloth in the end.
Note：
- Do not drop the cleaning fluid directly on the lens.
- As the lens has surface coating, the time for every cleaning should not be more
than 30 s, and the lens should not be pressed or rubbed hard.
6.3 Storage
If the instrument will not be used for a long time, it should be wiped clean and
placed in the packing box, and then stored in a dry and dust-free place.
6.4 Transportation and storage

Transportation: The instrument should be free from rain and snow, and it can be
transported in any modes provided that it is not mixed with corrosive substances or gases.
Storage: The product with complete package should be stored in a dry and ventilated
warehouse that is free of corrosive substance and intense magnetic field.
17
Transportation and storage conditions:

Ambient temperature: -40~55°C
Atmospheric pressure: 500~1,060 hpa
Relative humidity: ≤95%
6.5 Replacement of battery

Note:
-If the battery is subject to obvious damage or run out of capacity, it should be
replaced.
-Only the battery with the specifications specified by manufacturer can be used for
replacement, i.e. L50 AC 193 A 7.2 V, 2.2 Ah.
-The battery replacement, requiring no professional, can be completed by the user
according to the following method.
-Before the battery replacement, it is required to first turn off power supply of the
camera device and disconnect the control line.
Figure 6-1 Figure 6-2
Figure 6-3 Figure 6-4

Replacement method:
 Open the battery cover;
 Take out the battery and disconnect the connecting line between the battery and
the camera device;
 Connect the new battery with the camera device, and put it into the camera
device;
 Close the battery cover.
Precautions:
 The replaced batteries should be disposed according to relevant provisions on
18
waste electronic products instead of being discarded randomly, so as to avoid

pollution to the environment.
 It is forbidden to immense the batteries in water, and during standby, they should
be placed in a cool and dry environment;
 It is forbidden to use or place the batteries besides high temperature heat
sources (e.g. fire and heater);
 It is forbidden to use the battery with the positive and negative electrodes
reversed;
 Please use special lithium battery charger for charge;
 It is forbidden to throw the batteries into fire or heater;
 It is forbidden to transport or store the batteries together with metals, such as
hairpins, necklaces, etc.;
 It is forbidden to knock, throw or stamp on the batteries, etc.;
 It is forbidden to weld the batteries directly;
 It is forbidden to pierce the batteries with nails or other sharp objects.
6.6 Charge of battery
Figure 6-5 Battery Charging Method for KN-2200I
Figure 6-6 Battery Charging Method for KN-2200I(H)

The camera device should be charged according to the above connections. When it
is in charging status, the charging indicator will be red; when it is fully charged, the
indicator will change to blue. It takes about five hours to obtain charging volume of 90%,
and the fully charged instrument can be used for two hours.
19
Chapter VII Common Faults and Causes
Fault phenomenon Possible causes and handling methods
 Check whether all connections of the computer are

The computer cannot be
properly connected.
started.
 Check whether the computer power supply is damaged.
The computer shows a  Check whether the memory chip is tightly inserted or
blank screen and gives damaged.
alarm after start.  The memory or mainboard is damaged.
The computer is subject

to crash or circulating  The CPU fan is not installed properly or damaged.
start-up after entering the  The power supply is not stable.
system.
 The display switch is not turned on.

The color display does not
 Check whether signal line of the display is inserted
display.
properly.
 The capture card driver is subject to error.

The lens shows a blank  The signal line between the camera and the computer
screen after the camera is is subject to loose contact.
opened.  There are conflicts between software as multiple
applications are opened at the same time.
 The printer power supply is not turned on before the

printing command is sent. Cancel the order and send
The printer does not print again.
or there are random
 Check whether connecting cable of the printer is
characters in the printed
properly connected.
contents.
 Check whether there is a lack of paper.
 Check whether the printer type selected is correct.
 The software is not registered.

The software cannot work
 The decoder is not installed.
normally.
 The encryption dog is not inserted.
The software cannot

 The lens type selected in the software is not correct.
control the lens or the
 The control line is subject to connection error.
lens is subject to blue
Reconnect it according to the manual.
screen.
Imaging cannot be  The foot switch is damaged. Replace the foot switch.
implemented.  The control line is subject to connection error.
20
 The camera device is damaged. Contact the

manufacturer.
 The control line is subject to connection error.
 The capture card driver is not installed properly.
The image cannot be
Reinstall it according to the manual.
captured or there is a
 The capture card is damaged. Replace the capture
blank screen.
card.
 The serial port in the Software Settings is selected as
"COM1".
 There are conflicts between software as multiple
applications are opened at the same time.
 The camera device or control line is damaged. Contact

the manufacturer for replacement.
The lens cannot be  The control line is subject to connection error.
controlled. Reconnect it according to the manual.
 The USB port is not detected. Conduct "USB port
check".
There is no image in the  The "new patient" is not clicked.

comparative analysis.  No image is taken.
21
Chapter VIII After-sales Service
1. During the warranty period, for all faults due to product quality, the After-sales Service
Center of the Company will offer free repair or replacement of accessories. Please do
not disassemble the machine for repair without permission.
2. In case of any special requirements for the services, the user can consult relevant
issues with the After-sales Service Center of the Company
3. Relevant technical data of the instrument can be provided to the technical service
staff authorized by the Company as necessary.
4. The Company will not offer free warranty services for faults as a result of the following
causes:
 Faults due to disassembly & assembly or modification of the instrument without
permission.
 Faults due to accidental break or drop during use or handling.
 Faults due to lack of reasonable maintenance or failure to meet the environment
requirements for use.
 Faults due to failure to conduct proper operation as required in the user manual.
 Damage to the instrument and accessories due to human causes.
 Faults due to maintenance without permission of the Company.
 Faults or damage due to force majeure such as fire or earthquake.
22
Appendix A Assembly of Cantilever Support
(For KN-2200I only)
 Put the support in the base, fit M8*25 socket head cap screws from the bottom in
alignment with the installation holes, tighten them with a wrench, then put the
cantilever in the support, and fasten it with screws around:
Cantilever
②
Fastening
screw
Support
①
Base
M8*25 socket head cap screw

Figure 1
23
 Screw the cradle head to top of the support lever:
Cradle head
Cantilever
support
Figure 2
 Adjust the cantilever support

The user can adjust rotor strength of the cantilever according to specific usage.
②Damping
adjusting screw
②Damping ①
adjusting screw
Figure3
① +： Increase damping of the cantilever; -: reduce damping of the cantilever; use M6

Allen wrench for adjustment
② Use M3 Allen wrench for adjustment
24
Appendix B Assembly of Cart

(For KN-2200I(H) only)
1. Assembly of cart
⑦ 6 M4*10 cross recessed

countersunk head screws The handle is optional.
⑥4 M4*10 cross recessed

countersunk head screws
⑩ Install line card on

the cart
⑩
The bar code gun 将

rack is optional.
线
装
⑤4 M6*10 hexagon socket ⑧4 cross recessed round
countersunk head screws 到 head screws
①Remove this
piece first
⑨4 M4*10 cross recessed
④ 8 M6*10 hexagon socket
③4 M6*16 hexagon socket

head cap screws
②5 M6*16 hexagon
socket head cap screws
Figure 1
25
2.Assembly of equipment: (The computer, printer, display are beyond the

composition, and the product is reserved with interfaces, so the user can configure them
by itself.)
Display
Camera
device
Cradle
head
4 M4*10 cross recessed

pan head screws
Remove the glue on back of the

keyboard pad, stick it to the cart
table, and then place the keyboard
Computer
Place the
mouse
Fix the computer
with binding
bands
Printer
Place the bar code

gun (optional)
Wireless receiving
box (optional)
2 M3*6 cross recessed

pan head screws
Figure 2
26
 Adjust angle of the display
After installation of the display, if it feels too loose or tight when rotating, adjust
two adjusting screws with the attached wrench clockwise for tightening or
counterclockwise for loosening till the display can both be easily rotated and fixed at
any position.
Adjusting screw
Figure 3
 Adjust the cantilever support

The user can adjust rotor strength of the cantilever according to specific usage.
②Damping
adjusting screw
②Damping ①
adjusting screw
Figure 4
① +: Increase damping of the cantilever; -: reduce damping of the cantilever; use M6

Allen wrench for adjustment
② Use M3 Allen wrench for adjustment
27
Appendix C Installation of Camera Device

1． The functions of regulating mechanisms of the cradle head are as shown in the figure
below:
Figure 1
2． Unscrew the installation plate locking knob, and remove the installation plate of
camera device on the cradle head:
Installation plate of
camera device
Installation plate
locking knob
Figure 2
3． Install the installation plate of camera device on the fixing plate at bottom of the
camera device as shown in Figure 3, tighten the screws as shown in Figure 4, and
then lay the pull ring flat after installation, of which the effect is as shown in Figure 5:
Installation
Pull ring
plate
Fixing plate
Figure 3 Figure 4 Figure 5
4． Reinstall the installation plate of camera device in the cradle head, and tighten the
installation plate locking knob.
Figure 6
28
Appendix D Declaration of the EUT
Guidance and manufacture’s declaration – electromagnetic emissions-

for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission

The KN-2200ⅠColposcope System is intended for use in the electromagnetic environment specified below. The
customer or the user of KN-2200ⅠColposcope System should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
The KN-2200ⅠColposcope System uses RF energy
RF emissions only for its internal function. Therefore, its RF
Group 1
CISPR11 emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions The KN-2200ⅠColposcope System is suitable for use
Class B
CISPR11 in all establishments, including domestic
Harmonic emissions establishments and those directly connected to the
N/A
IEC 61000-3-2 public low-voltage power supply network that supplies
Voltage fluctuations / buildings used for domestic purposes.
flicker emissions N/A
IEC 61000-3-3
Guidance and manufacture’s declaration – electromagnetic emission

The KN-2200Ⅰ(H) Colposcope System is intended for use in the electromagnetic environment specified below.
The customer or the user of KN-2200Ⅰ(H) Colposcope System should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
The KN-2200Ⅰ(H) Colposcope system uses RF
RF emissions energy only for its internal function. Therefore, its RF
Group 1
CISPR11 emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions The KN-2200Ⅰ(H) Colposcope System is suitable for
Class A
CISPR11 use in all establishments, including domestic
Harmonic emissions establishments and those directly connected to the
N/A
IEC 61000-3-2 public low-voltage power supply network that supplies
Voltage fluctuations / buildings used for domestic purposes.
flicker emissions N/A
IEC 61000-3-3
29
Guidance and manufacture’s declaration – electromagnetic immunity –

for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity

The KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope System is intended for use in the electromagnetic
environment specified below. The customer or the user of the KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope
System should assure that it is used in such an environment.
Electromagnetic environment
Immunity test IEC 60601 test level Compliance level
- guidance
Floors should be wood, concrete or
Electrostatic discharge
6 kV contact 6 kV contact ceramic tile. If floors are covered with
(ESD)
8 kV air 8 kV air synthetic material, the relative humidity
IEC 61000-4-2
should be at least 30%.
2 kV for power supply
Electrostatic 2 kV for power supply Mains power quality should be that of a
lines
transient/burst lines typical commercial or hospital
1 kV for input/output
IEC 61000-4-4 1 kV for input/output lines environment.
lines
Mains power quality should be that of a
Surge 1 kV differential mode 1 kV differential mode
typical commercial or hospital
IEC 61000-4-5 2 kV common mode 2 kV common mode
environment.
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
Mains power quality should be that
for 0.5 cycle for 0.5 cycle
of a typical commercial or hospital
environment. If the user of the
40% UT 40% UT
Voltage dips, short KN-2200Ⅰ/KN-2200Ⅰ(H)
(60% dip in UT) (60% dip in UT)
interruptions and Colposcope System requires
for 5 cycles for 5 cycles
voltage variations on continued operation during power
power supply input mains interruptions, it is
70% UT 70% UT
lines recommended that the
(30% dip in UT) (30% dip in UT)
IEC 61000-4-11 KN-2200Ⅰ/KN-2200Ⅰ(H)
for 25 cycles for 25 cycles
Colposcope System be powered
from an uninterruptible power
<5% UT <5% UT
supply or a battery.
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency Power frequency magnetic fields
(50/60Hz) magnetic should be at levels characteristic of a
3A/m 3A/m
field typical location in a typical commercial
IEC 61000-4-8 or hospital environment.
NOTE： UT is the a.c. mains voltage prior to application of the test level.
30
Guidance and manufacture’s declaration – electromagnetic immunity –

for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity

The KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope System is intended for use in the electromagnetic environment specified
below. The customer or the user of the KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope System should assure that it is used in
such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope System,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3 Vrms
 3.5 
IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80
d   P
MHz V  1 
Radiated RF 3 V/m 3 V/m
 3.5 
IEC 61000-4-3 80 MHz to 2.5 GHz d   P
 E1  80 MHz to 800 MHz
7
d   P
 E1  800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m). b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, ashould
be less than the compliance level in each frequency
range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from
structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope System is used exceeds the
applicable RF compliance level above, the KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope System should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
31
Recommended separation distances between portable and mobile

RF communications equipment and the EQUIPMENT or SYSTEM –
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between

portable and mobile RF communications equipment and the KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope System
The KN-2200Ⅰ/KN-2200Ⅰ(H) Colposcope System is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the KN-2200Ⅰ/KN-2200Ⅰ(H)
Colposcope System can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment transmitters) and the KN-2200Ⅰ/KN-2200Ⅰ(H)
Colposcope System as recommended below, according to the maximum output power of the communications
equipment
Separation distance according to frequency of transmitter
Rated maximum output of (m)
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(W)
 3.5   3.5  7
d   P d   P d   P
 V1   E1   E1 
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
32

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Colposcope System user’s manual

Company Name: Xuzhou Kernel Medical Equipment Co., Ltd.

Company Address: Kernel Mansion, Economic Development District, Xuzhou City,

Jiangsu Province, China Zip Code: 221004

Tel：+86(516)87732209 Fax: +86(516)87732210

Web: www.kernelmed.com Email: [email protected]

Please carefully read in the "safety requirements" and

1.1 CONTRAINDICATIONS .................................................................................................................. 1

CHAPTER II OVERVIEW ................................................................................................................. 6

2.1 FUNCTION OVERVIEW .................................................................................................................. 6

CHAPTER III INSTALLATION AND CONNECTION ................................................................... 11

3.1 PRE-INSTALLATION CHECK ........................................................................................................ 11

CHAPTER IV SUGGESTED CLINICAL OPERATIONS ............................................................. 12

4.1 APPARATUS AND REAGENTS FOR EXAMINATION ......................................................................... 12

CHAPTER V OPERATION AND USE OF THE SYSTEM ........................................................... 13

5.1 OPENING AND CLOSING OF THE SYSTEM ..................................................................................... 13

CHAPTER XI MAINTENANCE ...................................................................................................... 16

6.1 MAINTENANCE OF THE INSTRUMENT AND ITS ACCESSORIES ........................................................ 16

CHAPTER VII COMMON FAULTS AND CAUSES...................................................................... 20

CHAPTER VIII AFTER-SALES SERVICE .................................................................................... 22

APPENDIX A ASSEMBLY OF CANTILEVER SUPPORT .......................................................... 23

APPENDIX B ASSEMBLY OF CART ........................................................................................... 25

APPENDIX C INSTALLATION OF CAMERA DEVICE ............................................................... 28

APPENDIX D DECLARATION OF THE EUT ............................................................................... 29

Chapter I Safety Requirements and Precautions

(Please read this chapter carefully before use of the instrument!)

 Contraindications - The equipment is absolutely forbidden for use under such

 Warnings——used to identify a hazard that may lead to death or serious injury.

 Precautions——used to identify a hazard that may result in minor or moderate

injury to the user or patient or damage to the equipment or other property.

 Note - General precautions.

 It is forbidden to perform vaginal operations, such as gynecological examinations,

 The electromagnetic field is likely to have interference on normal work of the

medical staff. Any personnel unauthorized or untrained will not be allowed to

 Before using the instrument, please strictly confirm the indications,

maximum load capacity is AC 10 A/250 V.

 Disposal of the system and accessories

 Precautions for colposcopy examination

KN-2200 series colposcope digital imaging system combines digital imaging

2.1 Function overview

For clinical examination of such parts as vulva, vagina, cervical, etc.

Features of the instrument

 Brand new combined cart, which is flexible, convenient and space-saving.

2.2 Structure composition

KN-2200I is a kind of standard definition camera device, while KN-2200I(H) a high

2.3 Main technical parameters

 Operation mode: Continuous operation.

2.4 Description of markings

manual and packing list)

Waste disposal marking

Refer to user’s manual

IPX1 Drip-proof equipment

Turn on/off the LED light source

Enhance red light of the image

Reduce red light of the image

Magnify the image being observed

Reduce the image being observed

Adjust the focus farther

Adjust the focus nearer