User Manual Colpoview c1
User Manual Colpoview c1
Technologies
BPL ColpoView C1
www.bplmedicaltechnologies.com Follow us on
Responsibility of the Marketer
BPL Medical Technologies Private Limited otherwise referred as BPLMTPL in this manual only considers itself
responsible for any effects on safety, reliability and performance of the equipment if:
The device is used according to the instructions for use presented in this manual.
The device is transported, stored & used in environment conditions as specified in User’s Manual.
This User’s Manual is prepared with the objective of providing the user with all the information necessary to
obtain the best use of BPL ColpoView C1.
In addition to the description of the device functions, the following documentation will be found with this manual:
For the purpose of improvement and betterment, Specifications and Operating Characteristics of
the BPL ColpoView C1 are subject to change without prior notice.
Statement
This manual contains exclusive information protected by copyright laws and we reserve its copyright. Without written
approval of manufacturer, no parts of this manual shall be photocopied, xeroxed or translated into other languages.
The contents and version contained in this manual are subject to amendments without notification.
Copyright
Registered Office:
BPL Medical Technologies Private Limited
11th KM, Bannerghatta Road, Arekere, Bangalore – 560076
Karnataka, India
www.bplmedicaltechnologies.com
Preface
Thank you for using BPL ColpoView C1.
In order to enable you to skillfully operate BPL ColpoView C1 as soon as possible, we provide this user's manual with
device. When you install and use this device for the first time, it is imperative that you read carefully all the information
that accompanies this device.
Based on the need to improve the performance and reliability of the parts and the whole device, we sometimes will
make some amendments to the device (including the hardware and software). As a result, there might be cases of
discrepancies between the manual and the actual situation of products. When such discrepancies occur, we will try our
best to amend or add materials. your comments and suggestions are welcome.
Contents
CHAPTER 1 Introduction & Safety ................................................................................................................................................................... 5
2.2.1 Appearance................................................................................................................................................................................ 12
1
5.1 Solution Preparation .................................................................................................................................................................... 29
6.5 Analyzing......................................................................................................................................................................................... 47
2
6.5.7 Performing Swede Evaluation .............................................................................................................................................. 56
3
7.1 Inspection ....................................................................................................................................................................................... 77
4
Chapter 1
Introduction & Safety
Product Name: Colposcope
Model: BPL ColpoView C1
Colposcope is used for gynaecological examination. It provides magnified visualization of the vagina, cervix and external
genitalia, which can help diagnose abnormalities and select areas for biopsy.
Thanks for choosing colposcope.
Please read this User manual completely prior to using this device.
Please carry out inspection and maintenance to the colposcope periodically as per the instructions given in the manual to
avoid patient/user injury.
1.2 Appearance
5
Observe all CAUTIONS and WARNINGS provided on the equipment, accessories and those provided in this manual.
Warning: Indicates hazardous situations or practices that could result in serious injury or death.
Caution: Indicates hazardous situations or practices that could result in minor injury or damage.
these personnel. Familiarize yourself with the contents of this user manual before operation.
Warning! Do not use the device in the presence of flammable anesthetics due to explosion risk.
SHOCK HAZARD – Do not attempt to connect or disconnect a power cord with wet hands. Make sure that your
Electromagnetic Interference – Ensure that the environment in which the device is installed is not subject to
any source of strong electromagnetic emissions, such as CT, radio transmitters, mobile phone base stations,
etc.
Electromagnetic Interference-Do not use mobile phones nearby the device, otherwise it may interfere with
device operation.
Do not touch the signal input or output connector and the patient simultaneously.
Accessory equipment connected to the device must be certified according to the respective IEC/EN standards
(e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment).
Furthermore, all configurations shall comply with the valid version of the system standard IEC/EN 60601-1.
If any question, please consult our technical service department or your local distributor.
Connecting any accessory or equipment to the device makes a medical system. In that case, additional safety
measures should be taken during installation of the system, and the system shall provide:
a) Within the patient environment, a level of safety comparable to that provided by medical electrical
equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical electrical equipment
For any non-medical electrical equipment forming part of the system to be used within the patient
environment, additional protective earthing should be applied or the non-medical electrical equipment
should be supplied via a separating transformer that complies with IEC/EN 60601-1. If no separating
transformer or other protective measure is applied, the non-medical electrical equipment must be used
6
outside the patient environment, and the system should be tested according to the requirements of IEC/EN
60601-1.
Do not exceed the maximum permitted load when using multiple portable socket-outlets to supply the
system. You can refer to the label or silk-screen for the maximum permitted load.
SHOCK HAZARD – Do not connect non-medical electrical equipment, which has been supplied as a part of the
system, directly to the wall outlet when the non-medical equipment is intended to be supplied via a multiple
SHOCK HAZARD – Do not connect electrical equipment, which has not been supplied as a part of the system,
Multiple portable socket-outlets shall not be placed on the floor. An additional multiple portable socket-outlet or
Do not connect any equipment or accessories that are not approved by the manufacturer or that are not
IEC/EN 60601-1 approved to the device. The operation or use of non-approved equipment or accessories with the device
tested or supported, and device operation and safety are not guaranteed.
Using accessories other than those specified by the manufacturer may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the device.
Make sure that all the components and accessories are connected correctly and checked before powering on.
No part of the device is intended to be maintained by the user. Unauthorized servicemen shall not open the
enclosure. Otherwise, safety hazards may happen.
The camera light source is very bright. When the camera is on, do not stare at the light source or aim the light
source at the patient's eyes.
The system is not for diagnosis or treatment, and it is a non-contact examination device. It should not touch
the patient during examination.
The mains plug is used as isolation means from supply mains. Position the device in a location where the
operator can easily access the disconnection device.
The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked
use is necessary,
the device should be observed to verify normal operation in the configuration in which it will be used.
The medical electrical equipment needs to be installed and put into service according to the EMC information
provided in this user manual.
Portable and mobile RF communications equipment can affect medical electrical equipment.
Do not service or maintain the device or any accessory which is in use with a patient.
Assembly of the device and modifications during actual service life shall be evaluated based on the
requirements of IEC60601.
CAU CAUTION
The device is designed for continuous operation. Do not water the device.
Keep the environment clean. Make the device far from corrosive medicine, dust area,
high-temperature and humid environment. Avoid vibration. Do not move it with the power cord connected.
Do not operate the device if it is damp or wet because of condensation or spills. Avoid using the device
immediately after moving it from a cold environment to a warm, humid location.
Do not sterilize the device or any accessory with autoclave or gas.
7
Do not plug any undefended USB device into the computer in which the video colposcope software
has been installed. Make sure that the connected USB device is free of viruses.
If the computer in which the video colposcope software has been installed will be connected to the
network, install genuine antivirus software to protect the computer against viruses.
Do not change the time of the system unless necessary, otherwise the appointment data may be lost.
The device and accessories are to be disposed of according to local regulations after useful lives.
Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal.
Patient environment means any volume in which intentional or unintentional contact can occur between the patient and
parts of the system or between patient and other persons touching parts of the system (reference IEC 60601-1). It is
difficult to apply unique dimensions to the volume, and the dimensions given in the figure below have been justified.
Overhead view
1.5 m
Examination
table
Side view
2.5 m
Examination table
Floor
1.5 m 1.5 m
1 Stand-by
2
Caution
3 USB connection
8
4 Power supply
5 Monitor
6 Signal input/output
7 CLASS II equipment
8 Foot switch
9
Operating instructions
10
Part Number
11
SERIAL NUMBER
13 Date of manufacture
14 MANUFACTURER
15 Disposal method
9
Warning
19 (Background: Yellow; Symbol&Outline: Black)
Sitting prohibited
20 (Background: White; Symbol: Black; Outline: Red)
Stepping prohibited
21 (Background: White; Symbol: Black; Outline: Red)
Pushing prohibited
22 (Background: White; Symbol: Black; Outline: Red)
10
Chapter 2
Product Features & Specifications
2.1 System Connection
Computer
Printer
Video colposcope
software
Camera
Foot switch
Video capture box
Power Target
Target
adapter
Electric
Electric signals
signals Power
Power supply
supply Optical
Optical signals
signals
WARNING
Accessory equipment connected to the device must be certified according to the respective IEC/EN standards (e.g.IEC/CN
60950 for data processing equipment and IEC/EN 0601-1 for medical equipment). Furthermore, all configurations shall
comply with the valid version of the system standard IEC/EN 60601-1. If any question, consult our technical service
department or your local distributor.
For any non-medical electrical equipment forming part of the system to be used within the patient earthing should be
applied or the non-medical electrical equipment should be supplied via a separating transformer that complies with
IEC/EN 60601-1.If no separating transformer or other protective measure is applied, the non-medical electrical equipment
must be used outside the patient environment, and the system should be tested according to the requirements of IEC/EN
60601-1.
Interface S-video
11
WARNING
The computer or monitor shall comply with the requirements of the valid version of IEC/EN 60950 and have relevant
certification (such as CE certification).
When connecting the computer or monitor to the device, ensure that the formed system meets the requirements of the
valid version of IEC/EN 60601-1.
2.2 Camera
2.2.1 Appearance
1 4
3
2
2
Camera
1 Key panel 2 3 Camera handle trigger
handle
12
2.2.2 Keys
2
5
3
6
Height adjustment
4 Camera holder 5 Lifting post 6
knob
7 Chassis 8 Casters
14
2.4 Swing Arm Stand(Optional)
By default, the swing arm stand includes the camera stand part. The monitor supporter part, keyboard tray part and laptop tray
part are optional. The swing arm stand in maximum configuration is as follows:
8
1
5
2 6
9
3
7
4
10
11
12
13
14
Figure 2.5: Swing arm stand (with the monitor supporter part and keyboard tray part)
Vertical angle
1 Camera holder 2 3 Holder post
adjustment knob
Horizontal arm- Horizontal angle
4 5 6 Swing arm
1 adjustment knob
Horizontal arm- Monitor supporter
7 8 Monitor supporter 9
2 post
13 Chassis 14 Casters
CAUTION
The maximum load of the monitor supporter is 3.5 kg, and that of the mouse tray is 0.5 kg. Do not put objects exceeding the
load on them.
15
1
4
1
2 4
2 2
3
3 2
16
1 2 3 4 5 6
4 Power switch
17
Chapter 3
Basic Operations
3.1 Opening & Checking the Package
Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim
for damage.
Open the package and check the components according to the packing list. Inspect the components for any damage. Let the
service engineer of the manufacturer assemble the system for you.
Keep the package for possible future transportation or storage.
When the stand is placed somewhere, step down the pedals to lock the casters and stop the stand from moving around.
When you need to move the stand, hold the lifting post with your hand and then push up the pedals to release the casters. After
you move the stand to the destination, step down the pedals again.
Push up to
release the caster
Figure 3.1
CAUTION
Do not move the stand by holding the camera handle, otherwise the camera may be damaged.
Step down the caster pedals to stop the stand from moving around.
Hold the lifting post with one hand, anticlockwise rotate the height adjustment knob to loosen it. Lift the post up or push it
down to the desired height.
18
CAUTION
When you loosen the height adjustment knob, hold the lifting post wiy one hand to avoid sudden fall of the camera.
Tighten
the knob
Loosen
the knob
Figure 3.2
To adjust horizontal angle: Hold the camera handle with your left hand and rotate the horizontal angle adjustment knob
anticlockwise with the other hand. Now you can tilt the camera left or right to the proper angle. Rotate the adjustment knob
clockwise to tighten it.
To adjust vertical angle: Hold the camera handle with your right hand and rotate the vertical angle adjustment knob
anticlockwise with the other hand. Now you can tilt the camera up or down to the proper angle. Rotate the adjustment knob
clockwise to tighten it.
Figure 3.3
CAUTION
Do not exert pressure downward more than 15 kg on the camera or it may hurt you or damage the device.
19
3.3 Adjusting the Swing Arm Stand
3.3.1 Placing/Moving the Stand
Each stand caster has a pedal. Step down the pedal can lock the caster.
When the stand is placed somewhere, step down the pedals to lock the casters and stop the stand from moving around.
When you need to move the stand, hold the stand post with your hand and then push up the pedals to release the casters. After
you move the stand to the destination, step down the pedals again.
CAUTION
Do not move the stand by holding the camera handle, otherwise the camera may be damaged.
When moving the stand, avoid the camera from hitting the door frame or other objects.
If the laptop tray or keyboard tray is configured, remove the laptop or keyboard placed on the tray before you move the
stand. Otherwise, the laptop or keyboard may fall down.
If the monitor supporter is configured, avoid the monitor or all-in-one PC installed on it from hitting the doorframe or
other objects when you move the stand.
Press down to
decrease the height
Lift up to increase
the height
Figure 3.4
Due to the locking force of the gas spring inside the swing arm, the swing arm can fix at the position after you release your hand.
The adjustment hole of the gas spring is in the swing arm axle connecting horizontal arm-2, as shown in the following figure:
20
Figure 3.5
If the swing arm continues to fall after you release your hand, it indicates that the locking force of the gas spring is too small.
You can use a 4 mm socket head wrench to rotate the adjustment hole of the gas spring to the "+" direction.
If the swing arm continues to rise after you release your hand, it indicates that the locking force of the gas spring is too large.
You can use a 4 mm socket head wrench to rotate the adjustment hole of the gas spring to the "-" direction.
Figure 3.6
You can adjust the angle at points A, B and C. Follow the instructions:
Point A: Hold horizontal arm-2 with one hand, and rotate the swing arm to the desired position on the horizontal direction
with the other hand.
Point B: Hold the swing arm with one hand, and rotate horizontal arm-1 to the desired position with the other hand.
Point C: Hold horizontal arm-1 with one hand, and rotate the holder post to the desired position by rotating the camera
handle with the other hand.
You can also adjust the camera angle by using the horizontal angle adjustment knob and vertical angle adjustment knob. The
operation is the same as that for adjusting the angle of the camera on the vertical stand.
CAUTION
Do not rotate the camera angle towards the same direction for multiple circles, otherwise the camera output cable may be
twisted or broken.
21
3.3.4 Adjusting the Position of Keyboard Tray or Laptop Tray
If the keyboard tray or laptop tray is configured, you can adjust its position on the horizontal direction. Either of the following
methods can be used:
Hold the stand post with one hand, and rotate the tray arm around the stand post to the desired position with the other hand.
Hold two sides of the tray with both hands, and rotate it to the desired position.
CAUTION
Adjust the position of the tray in a slow and gentle manner, otherwise your hands or arms may be hit by another part of the
swing arm stand and get hurt.
To adjust horizontal angle: Hold the left and right sides of the monitor with both hands, then tilt it left or right to the desired
angle.
To adjust vertical angle: Hold the top and bottom sides of the monitor with both hands, then tilt it up or down to the desired
angle.
CAUTION
When tilting the monitor, be careful not to jam your hands between the monitor supporter and the monitor.
22
Chapter 4
Software Installation
NOTE
The video colposcope software applies to operating system Windows XP, Windows 7, Windows 8 and Windows
8.1, Windows 10.
Before software installation, ensure that all the equipment forming the system has been connected and the
camera has been switched on.
Before software installation, close any antivirus software.
Replace or update of the software must be performed by professional personnel of BPLMTPL or under their
guidance.
1. Open the CD. The available directories, files, and programs are as follows:
Figure 4.1
Figure 4.2
23
Figure 4.3
It takes some time for the software installation preparation. Please wait. When the installation is ready, the
following interface is displayed. Click Next.
Figure 4.4
4. The following prompt is displayed. Click Next after you check the items.
24
Figure 4.5
5. Click Browse to select the installation path. The default path D:\Cx\Cx_Workstation is recommended. Then,
click Next.
Figure 4.6
NOTE
If disk D does not exist in the system, the default path is invalid. Please select another path.
6. Click Browse to select the database installation path. Do not select C:\Program Files. The default path
D:\Cx\Cx_Database is recommended. Then, click Next.
25
Figure 4.7
7. Click Next to continue installation. Do not close the black command prompt windows.
Figure 4.8
26
Figure 4.9
Figure 4.10
For operating system Windows 7, Windows 8 or Windows 8.1, a prompt will be displayed, asking you whether
to install the software driver. Choose to install the driver, as shown in the following figure (Windows 8 is used
as an example).
Figure 4.11
27
NOTE
If the driver is not installed, when you try to access the Examine interface or to set the capture card on the Setup
interface, a system prompt will be displayed, indicating that initializing video module failed. For details about
the troubleshooting, see relevant descriptions in Error! Reference source not found..
Figure 4.12
28
Chapter 5
Clinical Operations
NOTE
The colposcope is used to observe the tissues of vagina, cervix and external genitalia. Reduce interference and
stimulation to the check parts before examination. For example, sexual intercourse, gynecological check, local
biopsy or treatment should be avoided within 24 hours before vaginal or cervical colposcopy.
For the patient with acute infection, such as trichonomal vaginitis, monilial vaginitis, treatments should be taken
to control the infection first, and do not perform colposcopy before local acute inflammation is cured.
To acquire optimal examination effect, it's recommended to perform colposcopic examination 3 to 7 days after
the menstruation.
Instruments and materials needed for colposcopic examination: colposcope, speculum, forcep, normal saline, 5%
dilute acetic acid solution, Lugol's iodine solution, cotton balls and cotton swabs, etc.
5 ml glacial
acetic acid
Carefully add 5 ml of glacial Store the solution in a well-
acetic acid into 95 ml of sealed brown glass bottle. The
distilled water and mix them unused solution should be
thoroughly. discarded at the end of the day.
95 ml distilled
water
NOTE
Remember to dilute the glacial acetic acid, as the undiluted glacial acetic acid will cause a severe chemical
burn if applied to the epithelium.
29
Ingredient Preparation Storage
1. Dissolve 10 g potassium
10 g potassium
iodide in 100 ml of distilled
iodide
water.
100 distilled 2. Slowly add 5 g iodine Store the solution in a well-sealed brown bottle. The
water crystals while shaking. solution can be stored for 1 month.
2. Input patient information and enter the Examine interface of the video colposcope system.
1) Choose a proper speculum for the patient according to her age, figure and examination purpose.
2) Gently insert the speculum into the vagina, with the blades separated to gradually expose the cervix.
Rude insertion should be avoided, as this may cause bleeding, obscuring the view. Gentle insertion is specially
needed for patients with cervical cancer.
Exposure of the whole cervix is recommended to have optimal visualization of the cervix.
1) Locate the camera at the magnification of X09 (default magnification) till the image on the screen is clear.
2) Zoom in/out to the suitable magnification level for better visual examination.
In AF mode, you can press the "DISPLAY/F-" key to view the magnification.
1) Assess the colour, turbidity and pattern of cervical secretions of the patient, and capture an image.
If cytological examination is necessary, take a sample. (Be careful not to damage the cervical surface.)
2) Remove secretions from the vaginal and cervical surface with saline-soaked cotton balls.
3) Observe the cervical surface, and capture one image of the whole cervix and one image with green filter
respectively.
1) Wipe off normal saline on the cervical surface with dry cotton balls.
2) Use a large cotton ball soaked with 5% dilute acetic acid solution to cover the entire cervical surface, and
3) Remove the cotton ball after 50 seconds, and wipe off the mucus on the cervical surface.
4) Capture one image of the whole cervix at T1:00, T1:30, T2:00 and T2:30 respectively.
If abnormal vessels appear after T1:30, magnify the image or activate green filter for viewing. If necessary, you can
capture one image of the whole cervix at T3:00.
1) Apply Lugol's iodine solution on the acetowhite epithelium, cervix, then vagina with cotton swabs.
4. Based on the captured images, perform operations such as analysis and printing reports.
30
Chapter 6
Application of the Video Colposcope Software
NOTE
During normal running of the system, do not remove the USB connection between the computer and the video
capture box.
Double-click the software icon on the desktop. The system login interface is displayed.
Figure 6.1
The drop-down menu of Name lists all existing usernames. Select your username, input the correct password and
then click Login. Your username is shown on the top of the displayed main interface, for example,
For the first login, use the name sys and the default password is sys. After you log in to the system, you can add
more users by using the procedures described in b) Adding a User.
NOTE
You are advised to change the password of user sys after the first login.
31
1
Figure 6.2
Info. button in the tool bar to switch to this interface. On this interface, you can input patient information,
view today's exam schedule, search for a re-examined patient, make appointment, or manage follow-up patient
data.
Click the Patient Info. tag to open the Patient Info. interface.
On the Patient Info. tab, input the patient information, e.g. name, age, and reason.
32
Figure 6.3
If Yes is selected for Menopause, Menopause Age instead of LMP is displayed and must be specified.
You can click for more patient information, for example, marital status and gravidity. The button changes
to the button. You can click to hide the patient information again.
Figure 6.4
On the Indications for Colposcopy tab, select the clinical indication and input information about TCT, HPV, or
histopathology based on the patient's actual conditions.
Figure 6.5
NOTE
Examining Time can only be the current day or an earlier day.
For Reason, TCT, HPV, and Histopathology, you can manually input the information or click to open the Select
Term page and select relevant terms.
On the Select Term page, you can also perform term maintenance. Click Term Maintenance to enter the Term
Maintenance page. On this page, you can add, modify, delete, or move up or down a term.
33
Figure 6.6
Figure 6.7
34
NOTE
Certain terms provided by the system cannot be modified or deleted. When you double-click such a term to
select it, the Save and Delete buttons are unavailable.
After you input patient information and indications for colposcopy, click Add Patient, this patient is added to
today's exam schedule. Or you can click Start, this patient is added and the system enters the Examine interface
automatically. You can click Clear to delete all the inputted information.
By default, the list is sorted based on Item and Status as follows: Unexamined patients are listed preceding
examined patients, and within each group, patients are sorted by Item in ascending order. You can click another
item name such as Age, and the list is then sorted in this order. Click this item again, the list is sorted in reverse
order.
Figure 6.8
Select a patient in the list and right-click it, you can choose to browse her examination record, modify her
information or delete her information.
You can only view the examination record but cannot edit it.
35
Figure 6.9
NOTE
If a patient in today's exam schedule is not examined, her information will be deleted the next day. Therefore,
you need to modify App. Time for her and the system makes the appointment.
App. Time and Physician are available for modification only when the patient is unexamined and not the
current patient.
NOTE
The current patient's information cannot be deleted.
Once a patient's information is deleted, this examination record of hers in the database is deleted as well.
In the Re-examination Search area, select a condition, then input the keyword. If the condition is Name or Patient
No., the system supports fuzzy search, and you can search by inputting only part of the keyword. The more
information you input, the more accurate result you will get.
36
Figure 6.10
Click Search, all the patients that meet the condition will be displayed in the Re-examining Patient list. Click
Refresh, the today's exam schedule is shown again.
Select a patient in the Re-examining Patient list, her information is shown above. You can edit the information.
Click Add Exam, this patient is added to today's exam schedule and the system shows today's exam schedule again.
Or you can click Start, this patient is added to today's exam schedule and the system enters the Examine interface.
You can click Clear to delete the inputted information.
Figure 6.11
37
Figure 6.12
Click the Appointment tag to open the Appointment interface. Input information such as
patient name, age and appointment time on the Patient Info. tab and indications on the Indications for Colposcopy
tab, then click Save. The appointment is made, and the patient's information is shown in the appointment list below.
The appointment time can be the current day or a future day. If the user type of the doctor login is nurse, the system
will move the patients whose appointment time is the current day to Today's exam schedule; if the user type of the
doctor login is not nurse, the system will move the patients whose appointment time is the current day to Today's
exam schedule only when the appointed physician is the doctor login or not specified.
NOTE
Every login user can view all the appointment information.
In the Appointment Search area, select a condition, then input the keyword. If the condition is Name or Patient No.,
the system supports fuzzy search, and you can search by inputting only part of the keyword. The more information
you input, the more accurate result you will get. If the condition is App. Time, the result will include all the
appointment records of the inputted date and dates after it.
Click Search, all the patients that meet the condition will be listed.
You can select multiple pieces of the appointment information and delete them at the same time.
38
6.3.11 Follow-up Management
If the patient appointment function is enabled (see section j) Enabling Patient Appointment), the Follow-up tag is
available.
Figure 6.13
Click the Follow-up tag, the follow-up patients to be processed in or before the specified follow-up period will be
displayed. The list shows the patients by follow-up date in ascending order, and the Follow-up tag shows the total
number of records. For setting of the follow-up period, see section b) Setting Follow-up Period.
Select a patient in the list, her information will be displayed in the area above. You can modify the follow-up status,
follow-up date, or remark, and click Save. The inputted follow-up date cannot be earlier than the current day. If the
follow-up status is changed to Cancelled, the follow-up visit will be cancelled for the patient; if changed to To
Appointment, the system will make the appointment for the patient, and the Appointment interface shows this
appointment record, in which the appointment time is the follow-up date.
Input search conditions in the Search area, and click Search, all the patients that meet the conditions will be
displayed in the follow-up list. Click Refresh, the original follow-up list is shown again.
Click Cancel All, the follow-up status of all the patients whose follow-up date has expired will be set to Cancelled.
NOTE
You cannot modify information of the patients whose follow-up status is "To Appointment".
After the bar code scanner function is enabled (System Setup>General Setup>Scanner Setup>On), you can scan the
patient bar code on the Patient interface or Appointment interface with the scanner, and the patient’s information,
including patient number, patient name, birthday and age, will be entered automatically. The rest information can
be entered manually. Click “Add Patient” (Patient interface) or “Save” (Appointment interface) after entering
information.
6.4 Examining
Once a patient is selected on the Patient Info. interface, click Start on the interface or the Examine button
39
in the tool bar. The system enters the Examine interface, with the patient's key information displayed on
the lower left. On this interface, you can capture images, take video, make comparison, edit or measure the images.
NOTE
You can open the Examine interface only after the camera is connected to the computer and switched on.
If no image is displayed, check whether the USB connection between the computer and the video capture box
is normal.
Prompt
Figure 6.14
Click the Auto Capture tag , the auto capture function is enabled (which can also be enabled on
the Setup interface, see section p) Enabling Auto Capture), and the tag turns to . After you press
the "TIME" key of the camera, the system will automatically capture one image at specific time points. To disable
the auto capture function, click Auto Capture again.
If the function of providing examination prompts is enabled (see section o) Enabling Examination Prompts), the
system will show prompts after you press the "TIME" key of the camera. Perform operations according to the
prompts.
40
Prompt
Figure 6.15
NOTE
After you press the "TIME" key, the Auto Capture and Help tags become unavailable. They are available again
after you press the "TIME" key again or the current timer ends.
Click the Capture tag , the system captures the current image. The captured image is shown on the
right of the screen. A maximum of 50 images can be captured for a patient. You can double-click an image to
magnify it. You can click an image to select it, then right-click it and choose Delete to delete it. You can select
multiple images and delete them at the same time.
If the foot switch is connected, you can step on it to capture or freeze and capture the current image, depending on
the setting.
By default, the camera handle trigger is used to control coordinate display. Pull this trigger, the screen displays a
coordinate, as shown in the figure below.
41
Figure 6.16
The coordinate helps to locate the center of an image, facilitating image capturing. Pull the trigger again, the
coordinate disappears.
If the camera handle trigger is set to capture image, you can pull this trigger to capture the current image.
Click the Video tag , the system starts taking video. Click the Stop tag to stop taking
video. The video taking can last for at most one hour. Once one hour is reached, the system automatically stops
taking video.
The video is saved as an .avi file and the file is shown with a video symbol on the right of the screen. You can
double-click to play it.
Click the Comparison tag . The Comparison Analysis page is displayed, with the current patient's
information and image displayed on the upper left.
In the Search area, select a condition: Name, Patient No., Preliminary Diag., or DOB, input a keyword, then click
Search. All the cases that meet the specified condition are shown in the Case List. By default, the Compare Patient
Information area on the upper right displays the patient information and image of the first case in the list. You can
click a desired case in the Case List so that its patient information and image are displayed in the Compare Patient
Information area.
42
Figure 6.17
NOTE
For a re-examined patient, the Compare Patient Information area displays her last examination record, and the
Case List shows all of her examination records, with the latest examination records listed first.
You can click Record to view the corresponding examination record. You can double-click an image to magnify it,
Click Compare Images to compare image of the current patient with that of the compare patient. If you have
selected images, comparison starts from the first selected, otherwise it starts from the first patient image.
Figure 6.18
43
6.4.6 Analyzing
Click the Analysis tag to switch to the Analysis interface. For specific operations on the Analysis
interface, see section Error! Reference source not found. Error! Reference source not found..
In the Image Remark area, input remark for the image, then click Save to save the remark. A maximum of 50
characters (excluding "&") can be inputted. This remark will be shown together with the image.
You can add notes on the image as follows: In the Image Note area, click Note. Then move the cursor to the image
area and click on it. A broken line frame is shown, and you can type note in it. You can move the cursor to other
positions to add more notes. After all notes are added, click Save to save them.
A maximum of 20 notes can be added to an image, with each note containing no more than 30 characters.
Term area
Figure 6.19
The system allows quickly adding notes. Click a term in the term area, then click on the image at the desired
position, the term note is added to the image.
44
To modify note font: the font of notes can be set to small (S), medium (M), or large (L). Once a font is selected, it
applies to all notes.
To modify note content: click the note, the cursor flashes and the note becomes editable. Modify the content and
then click Save in the Image Note area.
To move a note: click and drag the note to the target position. Then click Save in the Image Note area.
To delete a note: right-click the note and choose Delete. The note is deleted. Then click Save in the Image Note
area.
To delete all notes: click Delete All Notes in the Image Note area, all notes are deleted.
Move the slider of Brightness/Contrast to the left to decrease or to the right to increase the brightness/contrast.
Click OK to save the setting.
4) Deleting an Image
Click the Delete button underneath the image to delete it. A prompt is issued. Click Yes to confirm the deletion, or
click No to cancel it.
If multiple images are available, you can click or to switch to the previous or next
image and then edit it in the same way. Click Exit or to close this page.
NOTE
If you choose default calibration, keep the camera at a distance of 25 cm from the target in vertical direction
while capturing images, and make the calibration magnification consistent with the actual magnification.
1) Default Calibration
Select Default and the magnification and you can measure the image by Line, Perimeter or Area. When you select
a desired area, the measurement result will be displayed nearby.
45
Figure 6.20
2) Manual Calibration
Select Manual and draw a line on the image with your mouse. Input the length (mm) of the line and click OK. If you
input 0 or any other invalid value, the following prompt will be issued: The input value is invalid, please input
again.
Figure 6.21
46
Then you can measure the image by Line, Perimeter or Area, and the measurement result will be displayed nearby.
To delete a piece of measurement data, right-click it, and choose Delete. You can click Clear Data to clear all the
measurement data on the image.
Clear Save, the current image with all the measurement data on it will be saved as a new image and displayed in the
patient image list. If you switch to the Image Editing tab, the measurement data will be cleared.
Chapter 6
6.5 Analyzing
Click the Analysis button in the tool bar to open the Analysis interface, or you can click the Analysis tag
on the Examine interface to switch to the Analysis interface. On this interface, you can perform
R-way evaluation, RCI evaluation, and Swede evaluation, and input examination result and biopsy result.
Figure 6.22
47
Figure 6.23
Figure 6.24
48
You can compare 2-6 images at the same time. If more than 6 images are selected, the first 6 images are compared
by default, and the button is available at the upper right corner of each image. You can click to delete an
image from the comparison page, and another selected image will be displayed instead. After the deletion, you can
right-click and choose Undo deletion to undo it.
Click Combine, images on the comparison page are combined into one image, which is also displayed in the Current
Patient Image area.
In the Current Patient Image area, select an image, right-click it and choose Delete, the image will be deleted. You
can select multiple images and delete them at the same time.
Figure 6.25
Click Select All, all the images will be selected. Click Select None, all the images will be deselected.
Right-click an image and choose Image Processing, the Image Processing page is displayed, and you can edit or
measure the image. For details, see sections 6.4.8 Editing an Image and 6.4.9 Measuring an Image.
NOTE
The R-way Evaluation tab is available only when the USB Sentinel for R-way evaluation is connected to the
computer and R-way evaluation is enabled (see section k) Enabling R-way Evaluation).
49
On the R-way Evaluation tab, observe normal saline test images, acetic acid solution test images, and Lugol's iodine
test images and make labels as required. The system will offer colposcopic preliminary diagnose and treatment
suggestion based on your observation and labels.
1 2
Figure 6.26
1 Labelling area 2 Image preview area 3 Evaluation step area
When the cursor is placed on an image in the Current Patient Image area, this image will be displayed in the image
preview area. You can double-click the image in the image preview area to magnify it, and you can move the
magnified image during evaluation.
In the evaluation step area, perform operations as instructed. During the process, you may be asked to mark labels
on the image in the labelling area. Click on the image to add labels. If you need to delete a label, click it or right-
click it and choose Delete. You can delete a label only in the corresponding labelling step.
When the evaluation is completed, the Evaluation Result sub-tab is displayed. It shows preliminary diagnosis and
treatment suggestion. If the treatment suggestion is biopsy, information (including the grade, quadrant, clock
direction and offset) about the recommended biopsy regions will be given in the list under Biopsy Region. If you
select Immediate Biopsy, a point will be displayed on the biopsy image on the left to indicate this biopsy region.
50
Figure 6.27
Click Preview, you can view the current R-way evaluation process.
If you want to re-evaluate, click Reevaluate. The system clears the evaluation result and shows the first evaluation
step again.
If endocervical curettage (ECC) or diagnostic conization is recommended, select ECC or Diagnostic Conization.
Click Accept, the system switches to the Examination Record tab, and the preliminary diagnosis and treatment
suggestion are loaded to the Examination Record tab, and information about the recommended biopsy regions is
loaded to the Biopsy Record tab. If there is any immediate biopsy region, on the Examination Record tab, Yes is
selected for Immediate Biopsy, and the Remark field under Colposcopic Primary Diag. will automatically add the
first term in the remark term list.
Click Cancel, the system switches to the Examination Record tab, without loading any information.
You can manually input colposcopic findings or click to select relevant terms.
Figure 6.28
51
Figure 6.29
Figure 6.30
52
Terms of colposcopic findings are listed on the left and classified into four categories: Normal, Abnormal,
Suspicious For Invasion and Miscellaneous Finding. Double-click a term, this term is added to the Selected Term
area. You can select multiple terms and edit them. Click OK, the selected terms are added to the Colposcopic
Findings field.
The current patient image is shown on the upper right of the page. If multiple images are available, you can click
or next to the Image Remark field to view the previous or next image. You can double-click an image to
magnify it, and double-click the magnified image or click on it to exit magnification.
Some terms are provided with reference images. Click such a term, its reference image is shown in the Reference
Image area. If multiple reference images are available for this term, you can click or next to the
Terminology field to view the previous or next reference image.
If the current patient image is a typical one, you can add it to be a reference image. Select the relevant term in the
term list, then click Add Ref. Image. The current patient image is added as a reference image of this term.
If you want to delete the current reference image, click Del. Ref. Image. A prompt is issued, asking you to confirm
the deletion. Click OK, the current reference image is deleted.
You can also click Term Maintenance and maintain terms on the displayed Term Maintenance page.
Under Colposcopic Primary Diag., you can manually input preliminary diagnose, treatment and remark or select
relevant terms by using the button next to the field.
Figure 6.31
For the follow-up date, you can select a specific date or a period later (for example, 1 month later or 3 months later),
or manually input the date.
If you select Yes for Immediate Biopsy, the system switches to the Biopsy Record tab.
NOTE
Only when you select a specific date as the follow-up date, A.M. and P.M. are available for selection.
Under Biopsy Region, you can click on the biopsy image to add a point to indicate an immediate biopsy region,
which is marked as XN (N is the Item number). Information (including the quadrant, clock direction, and offset)
about the biopsy region is automatically shown in the list on the right. Immediate Biopsy is selected by default, and
you can select the lesion grade from the Grade drop-down list. If Immediate Biopsy is deselected, the biopsy image
will show only the lesion grade (if selected) without a point.
53
The font of notes on the biopsy image can be set to small (S), medium (M), or large (L). Once a font is selected, it
applies to all notes.
If the software has the R-way evaluation function and the Remark field under Colposcopic Primary Diag. on the
Examination Record tab is empty, after you add an immediate biopsy region, this Remark field will automatically
add the first term in the remark term list; and when all immediate biopsy regions are deleted, the content in this
Remark field will be cleared.
Figure 6.32
If you want to delete a note, select this note in the list and click Del. Selected Note. If you click Del. All Notes, all
notes in the list and on the biopsy image will be deleted.
You can manually input biopsy pathology and remark or select relevant terms by using the button next to the field.
NOTE
The RCI Evaluation tab is available only when RCI evaluation is enabled (see section m) Enabling RCI
Evaluation).
On the RCI Evaluation tab, you can perform RCI (Reid Colposcopic Index) evaluation.
54
Figure 6.33
RCI evaluation is performed based on four aspects: colour, margin, vessel, and Iodine staining. Click the button,
the corresponding Select Term page is displayed. In the term list, each term has its score.
Figure 6.34
55
When you select a term and click OK, this term and its score are added to the corresponding fields on the RCI
Evaluation tab. If multiple terms are selected for one aspect, the score of this aspect is the largest value among the
scores of the selected terms. The system will calculate the total score and provide the RCI evaluation result based
on this score.
NOTE
You can modify terms of RCI evaluation, but you cannot modify term scores or add, delete, or move up or down
any term. When you first enter the Term Maintenance page, the Add, Save, Delete, Up and Down button are
invalid. The Save button becomes valid after you double-click a term to select it.
NOTE
The Swede Evaluation tab is available only when Swede evaluation is enabled (see section n) Enabling Swede
Evaluation).
Figure 6.35
Swede evaluation is performed based on five aspects: aceto uptake, margin/surface, vessel, lesion size, and Iodine
staining. Operations on the Swede Evaluation tab are similar to those on the RCI Evaluation tab, see section 6.5.6
Performing RCI Evaluation for reference.
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6.6 Examination Report
6.6.1 Printing the Examination Report
Select a patient and then click the Report button in the tool bar to open the Report interface.
Figure 6.36
The examination report is shown in detail in the middle of the interface. The captured images are shown on the
right.
If six images of the patient have been combined into one image using the combination function (see section 6.5.1
Comparing Images of the Current Patient), the examination report will show these images by default according to the
following principle:
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Once you switch the print template, the principle no longer works.
If you want to have an image shown on the report, drag it from the Current Patient Image list to the Image area of
the report. The original shown image (if any) will be replaced.
Click the Print tag on the left of the interface to start printing the report.
To obtain an optimal report, you are advised to set the print items first.
NOTE
You can double-click an image in the Current Patient Image list to magnify it, and double-click the magnified
If multiple images are available, click on the left or right of the magnified image to view the previous or next
image.
On the Report interface, click the Setup tag on the left to open the Setup page.
Figure 6.37
Select a print template and a printer, specify the number of copies, then click OK to save the settings.
Under Print Template, if you select a template other than Custom, the default print settings are used and print
items are unavailable for selection. If you select Custom, the print items are available for selection, and you can
select them as desired. The selected items will be shown on the report. You can click the Restore Factory Config
button under Print Patient Info. and Print Content to restore to the default settings. (By default, the 4-image print
template is used.)
58
NOTE
Whichever print template is selected, you can set the color of hospital name and hospital second name, or
define the report title. The color setting and report title applies to all print templates.
You can select a print template on the Setup page, or you can quickly select the print template by clicking the
You can also click the tag. The examination report is then displayed in the template that you have
customized on the Setup page.
On the Report interface, click the Export tag on the left, select a directory and then click Save. The
report is exported to the target directory.
NOTE
The Export tag is shown on the Report interface only after you select Export on the General Setup tab (see
section g) Enabling the Report Export Function).
On the Report interface, click the To PACS tag on the left to send the report to PACS.
NOTE
The To PACS tag is shown on the Report interface only after you select To PACS on the General Setup tab (see
section h) Enabling Sending Report to PACS), and it is available only after you enable DICOM on the Network
Setup tab (see section 4)a) Enabling DICOM).
The tag is unavailable after you click it, and it becomes available again when sending is complete.
You can send patient information, examination result, doctor and hospital information, etc. to the server.
During the sending process, if the system is disconnected from the server, the system will stay in the sending
state. You can restart the software and click To PACS again.
On the Report interface, click the Email tag on the left to send the report to the specified email
address.
NOTE
59
The Email tag is shown on the Report interface only after you enable the email function (see section 4)b)
Enabling the Email Function).
Click the Operation button in the tool bar to open the Operation interface.
Figure 6.38
Click the Print tag on the left of the interface to start printing the report.
On the Operation interface, click the Record tag on the left to open the Record page. On this page,
you can specify operation-related information. The specified items will be shown on the operation report.
60
Figure 6.39
For the follow-up date, you can select a specific date or a period later (for example, 1 month later or 3 months later),
or manually input the date.
NOTE
Only when you select a specific date as the follow-up date, A.M. and P.M. are available for selection.
The operation report will not show the post-operation pathology.
On the Operation interface, click the Setup tag on the left to open the Setup page.
On this page, you can only set the printer type, number of copies, and color of hospital name and hospital second
name, or define the report title. The report title is the operation report name, while settings of the other items stay
the same as those set for the examination report.
On the Operation interface, click the Email tag on the left to send the report to the specified
email address.
NOTE
The Email tag is shown on the Operation interface only after you enable the email function (see section 4)b)
Enabling the Email Function).
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6.8 History Case Database
Click the Database button in the tool bar to open the Database interface.
Figure 6.40
On this interface, all the cases of the examined patients are listed. Click one of the cases, the images contained in
this case are shown on the right of the interface.
The header of the list can be customized, see section f) Customizing the Database Header.
The list is sorted in the order of Item by default. You can click another item name such as Age, the list is then sorted
in this order. Click it again, the list is sorted in reverse order.
At the lower left corner of the interface, the number of the page (in the form of current page/total page, e.g. 1/10)
and page turning buttons are provided. If there are multiple pages, you can click to switch to the first page, click
to switch to the previous page, click to switch to the next page, or click to switch to the last page.
Alternatively, you can input the page number in the blank and click .
NOTE
You can double-click an image to magnify it, and double-click the magnified image or click on it to exit
magnification.
If multiple images are available, click on the left or right of the magnified image to view the previous or next
image.
Click the cell of the Attention column, the corresponding case is marked with the default attention label. Or you can
right-click to choose another attention label. A case marked with an attention label will be displayed in the colour
set for the label.
62
Figure 6.41
Figure 6.42
Choose Clear Attention or click the cell again, the attention label will be cleared. Choose Setup, the following page
is displayed.
Figure 6.43
There are five attention labels in total. You can customize the name or color for each label, or change the default
label, then click Save.
NOTE
This operation can be performed only by users having the permission of modifying history case. A chief
physician having this permission can mark attention labels for cases examined by other physicians, while
other types of users having this permission can only mark attention labels for cases examined by themselves.
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6.8.2 Searching for a History Case
To quickly search for a history case, perform the following procedures:
Input the name, patient number, or date of birth in the Records Search area. You can also specify examining time for
search. The more information you input, the more accurate result you will get.
Click Search, all the cases that meet the condition will be listed.
Select a case in the list, right-click it and choose Browse Patient Report. The patient report is displayed. You can
only view it but cannot edit it.
NOTE
This operation can be performed only by users having the permission of modifying history case. A chief
physician having this permission can modify the information of patients examined by other physicians, while
other types of users having this permission can only modify the information of patients examined by
themselves.
NOTE
This operation can be performed only by users having the permission of modifying history case. A chief
physician having this permission can modify the examination records of patients examined by other
physicians, while other types of users having this permission can only modify the examination records of
patients examined by themselves.
NOTE
This operation can be performed only by users having the permission of modifying history case. A chief
physician having this permission can modify the operation records of patients examined by other physicians,
while other types of users having this permission can only modify the operation records of patients examined
by themselves.
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6.8.7 Modifying Patient Report
Double-click a case in the list. The system switches to the Report interface, and you can modify the patient report,
for example, you can modify print setup, change print template, or replace the images shown on the report, etc.
NOTE
This operation can be performed only by users having the permission of modifying history case. A chief
physician having this permission can modify the reports of patients examined by other physicians. Other types
of users having this permission can only modify the reports of patients examined by themselves; if they
double-click the cases of patients examined by other physicians, they can only view the patient reports.
NOTE
This operation can be performed only by users having the permission of inputting pathology result.
NOTE
This operation can be performed only by users having the permission of deleting history case. A chief
physician having this permission can delete the information of patients examined by other physicians, while
other types of users having this permission can only delete the information of patients examined by
themselves.
You can select multiple cases and export them at the same time.
6.9 Statistics
NOTE
If there is a large amount of data in the system, performing statistics or exporting may take a few seconds, and
a progress bar will be shown. Please wait patiently and do not perform any operation to avoid system
breakdown.
Click the Statistics button in the tool bar to open the Statistics interface. On this interface, you can
perform statistics of the cases by items.
65
Figure 6.44
Select a statistics item, input the condition, then click Statistics. The result is shown on the right, including:
Name Description
It shows the quantity and proportion of each item that meet the
Data Comparison
condition.
Click a chart format, the chart is then shown in the corresponding format.
66
Linear Graph
Figure 6.45
Histogram
Figure 6.46
67
Pie Chart
Figure 6.47
After performing statistics, click the Export Record button. Select a directory, input the file name and then click
Save. The Excel file is saved in the target directory.
NOTE
The operation of exporting patient list or chart can be performed only by users having the permission of
exporting record & chart; otherwise, the system will issue a prompt, indicating that you are unauthorized.
You should install the Microsoft Office software in the system to open the exported file. A maximum of 60000
records can be exported.
After performing statistics, click the Export Chart button. Select a directory, input the file name and then click Save.
The Excel file is saved in the target directory.
Click the Switch User button in the tool bar to open the Switch User interface.
68
Figure 6.48
Select a username and input the correct password. Click Login, the user is switched. Or click Exit, the previous user
remains.
NOTE
Only users having the permission of system setup can open the Setup interface.
You are recommended to set the hospital information. After the setting, the hospital information will be shown in
the examination report and operation report.
2) On the User Management tab, input the hospital name, its second name, address and telephone number in
the Hospital Info. area. Click the button to import an image of the hospital logo.
3) Click OK.
NOTE
The hospital logo image should be in .jpg format and cannot exceed 512KB. For clear display on the report, it is
recommended that the hospital logo fill the whole image.
b) Adding a User
2) On the User Management tab, input the user name, type and password (Confirm Password should be the
same as Password) in the User Info. area. Click the button next to Signature to import an image of
the user's signature, and select the authority.
3) Click Add. This user is added to the User List on the right.
4) Click OK.
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5) Exit the system and restart the software immediately.
NOTE
The user's signature image should be in .jpg format and cannot exceed 512KB. For clear display on the report,
it is recommended that the user's signature fill the whole image.
The authority that can be selected varies with user types. By default, the administrator has all the authority.
For the chief physician, Setup cannot be selected, and for the doctor and the nurse, both Setup and Delete
History Case cannot be selected.
2) On the User Management tab, select a user in the User List, his/her information is shown on the left. You
can edit the information as required.
3) Click Modify.
4) Click OK.
d) Deleting a User
3) Click Delete.
4) Click OK.
2) On the General Setup tab, choose a date format from the Date Format drop-down menu.
3) Click OK.
NOTE
The date is shown in the same format as that of the operating system by default, unless the date format is
changed.
70
b) Setting Follow-up Period
2) On the General Setup tab, choose a period from the Follow-up Period drop-down menu.
3) Click OK.
The foot switch can be used to capture images only (the default function) or to freeze and capture images.
2) On the General Setup tab, select Capture Image Only or Freeze&Capture Image in the Foot Pedal Setup
area.
3) Click OK.
The camera handle trigger can be used to capture images or to control coordinate display (the default function).
2) On the General Setup tab, select Capture Image or Display Coordinate in the Camera Handle Trigger
Setup area.
3) Click OK.
2) On the General Setup tab, click the Capture Card Setup button. On the displayed page, set brightness,
contrast, hue, or saturation based on actual requirements by inputting a specific value or dragging the
slider. The setting will take effect immediately. (You can click Restore Factory Config to restore to the
default setting.)
3) Click Exit.
NOTE
You can open the capture card setup page only after the camera is connected to the computer and switched
on.
The header of the case list on the Database interface can be customized.
71
1) Click the Setup button to open the Setup interface.
2) On the General Setup tab, click the Database Header User-define button. On the displayed page, select
headers as desired, or move headers using the Up or Down button.
3) Click Save. (To restore to the default setting, click Default, then click Save.)
NOTE
Name, Age, and Examining Time are mandatory and cannot be deselected.
3) Click OK.
NOTE
The Export tag is shown on the Report interface only after you select Export on the General Setup tab.
3) Click OK.
NOTE
The To PACS tag is shown on the Report interface only after you select To PACS on the General Setup tab.
For operation convenience, you can set the software to run automatically once the host starts up.
2) On the General Setup tab, select Run on Startup in the Others area.
3) Click OK.
NOTE
If you enable automatic running on startup in Windows 7 or Windows 8 system, you need to disable User
Account Control (UAC) as follows:
72
1. Select Start button, input uac in the search box to enter Change User Account Control Settings.
2. If you want to disable UAC, move the slider to Never notify and click OK. If the system asks you to enter
administrator password, please input it and restart your computer.
3) Click OK.
2) On the General Setup tab, select R-way Evaluation in the Others area.
3) Click OK.
To use the R-way evaluation function, you also need to connect the USB Sentinel for R-way evaluation to the
computer.
NOTE
R-way Evaluation is selected by default. You can deselect it to disable the function.
You can switch the position of the R-way Evaluation tab with that of the RCI Evaluation tab on the Analysis
interface.
2) On the General Setup tab, select Switch R-way with RCI in the Others area.
3) Click OK.
2) On the General Setup tab, select RCI Evaluation in the Others area.
3) Click OK.
NOTE
RCI Evaluation is selected by default. You can deselect it to disable the function.
73
n) Enabling Swede Evaluation
2) On the General Setup tab, select Swede Evaluation in the Others area.
3) Click OK.
2) On the General Setup tab, select Image Capture Prompts in the Image Capture Setup area.
3) Click OK.
NOTE
Image Capture Prompts is selected by default. You can deselect it to disable examination prompts.
2) On the General Setup tab, select Auto Capture in the Image Capture Setup area.
3) Click OK.
You can also click the Auto Capture tag on the Examine interface to enable or disable auto capture.
Two modes are available: screening (the default mode) and diagnose. The system provides more image capture
prompts (if enabled) and captures more images with the auto capture function (if enabled) in diagnose mode than
in screening mode.
3) Click OK.
On the General Setup tab, click Restore Factory Config. Except the date format, capture card and database header,
other items on the General Setup tab will be restored to the default settings.
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6.11.3 Database Management
a) Backing up Database
2) On the Database tab, select the backup path. The default path is D:\DataBaseBackup.
3) Select the backup type (Auto Backup or Manual Backup).If you select Auto Backup, you need to select
number of days (1-100), and automatic backup is started after the software is restarted. If you select
Manual Backup, click Start Backup to start the backup.
4) Click OK.
NOTE
You can back up images in manual backup but not in auto backup.
b) Restoring Database
c) Exporting Terms
2) On the Database tab, click in the Export Term area to select a directory.
3) Click Export Term. The system starts to export terms to the target directory.
NOTE
For terms with reference images, their reference images will also be exported to the target directory.
d) Importing Terms
2) On the Database tab, click in the Import Term area to select the directory in which terms to be
imported are stored.
3) Click Import Term. The system asks you to confirm the import. Click Yes, the system starts importing.
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5) Exit the system and restart the software immediately.
NOTE
For terms with reference images, their reference images will also be imported. After importing is succeeded,
the original terms and reference images will be replaced with the imported ones.
a) Enabling DICOM
3) Input the PACS IP, Port Number, Calling AE Title and Called AE Title according to your server
configuration.
NOTE
To use the DICOM function, enable DICOM first and specify DICOM setup items correctly.
Before you use the DICOM function, ensure that the system connects to the server successfully.
3) On the displayed page, select Send Email, and complete email receiver and sender setup.
4) Click Test.
5) If sending the test email succeeded, click Save. If sending the test email failed, change the email setting
and test again.
NOTE
You can input several email receiver addresses, separating them with a semicolon (;).
5.12 Exit
Click the Exit button in the tool bar. A prompt is issued. Click Yes to exit the system, or click No to keep
the system.
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Chapter 7
Maintenance & Cleaning
7.1 Inspection
(1) Visual Inspection
1) Check the system and accessories to see if there is any visible evidence of damage that may affect the patient's or
operator's safety.
The overall check of the system, including safety check and function check, should be performed by qualified
personnel every 12 months or according to local regulations, and each time after service.
The equipment should undergo periodic safety testing to ensure proper patient isolation from leakage currents. This
should include leakage current measurement and insulation testing. The recommended testing interval is once a year
or as specified in the institution's test and inspection protocol.
WARNING
Failure on the part of the responsible individual hospital or institution employing the use of this equipment
to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health
hazards.
Do not touch the lens with your fingers. The grease on the fingers may damage the plating film on the lens, and
the finger print may affect the image quality as well.
Keep the lens dry, avoid exposing it in extreme temperature and humidity, and protect it from direct sunshine.
7.3 Cleaning
WARNING
Make sure that the power is off and the power cords are disconnected prior to cleaning or disinfecting the
device.
The device should be kept clean from dust, medical solution and reagent. Clean the device when necessary.
The recommended cleaning agents are:
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3. Wipe the surface with a soft dry cloth.
CAUTION
The device components are not waterproof. Do not immerse any components in water or allow liquids to enter
the cases.
In case of liquid splashing on the equipment, wipe it with dry cloth immediately to stop the liquid from entering
the interior. Stop using the device and contact the service personnel if accidental wetting occurs.
Do not allow any remaining solution on the surface of the device, wipe it clean with a cloth.
Make sure that a dedicated cleaning cloth is used when cleaning the lens. Common paper or tissue may scratch
the lens.
Only dedicated lens cleaner should be used to clean the lens, and it should not be applied on the lens directly.
7.4 Disinfection
This device does not have direct contact with the patient, and in order to protect the product, disinfection is not
recommended unless this is necessary according to your hospital regulation.
Ethanol (75%)
Isopropanol (70%)
2. Wipe the external surface of the device components, camera and cables using a soft cloth dampened with the
disinfectant.
Make sure that no liquid enters the cases, and the surface must be wiped clean in the end.
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Chapter 8
Product Specifications
8.1 Environmental Specifications
Temperature: +5 ºC ~ + 40 ºC ( +41 ºF ~ +104 ºF)
Standards Compliance IEC 60601-1: 2005, EN 60601-1:2006, IEC 60601-1-2: 2007, EN 60601-1-2: 2007
Degree of Protection against Device/Camera: ordinary equipment (sealed equipment without liquid proof)
Harmful Ingress of Water
Foot switch: IPX8
Disinfection/Sterilizing
Refer to this user manual for details
Method
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EMC CISPR 11 Group 1 Class A
Magnification: 1 ~ 36X
Illumination: ≥2500 lx
SNR: ≥ 50 dB
6X: ≥120 mm
Depth of field:
18X: ≥5 mm
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Chapter 9
Troubleshooting
9.1 No Access to Video Colposcope Software and Error Reporting
Unsuccessful connection
to the database.
1. Open the database installation directory. Eg. Open
D:\Cx\Cx_Database\data and delete postmaster.pid.
Database service
does not start.
The video capture card is faulty. Check the video capture card.
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package and find the
usbdriver\USBToCOM directory. If the
32-bit operating system is used, open the
X32 folder, right-click
installUSBtoCOM.bat and choose Run as
administrator. If the 64-bit operating
system is used, open the X64 folder,
right-click installUSBtoCOM.bat and
choose Run as administrator.
Select the incorrect printer in the print Open the print setup page and select the
setup. correct printer.
Unsuccessful connection The printer drive is not installed
to the printer. Reinstall the printer drive.
correctly.
No connection to the printer. Connect to the printer.
Please confirm whether
PDF Creator 0.9.6.0 is No PDF Creator 0.9.6.0 is installed. Install PDFCreator 0.9.6.0.
installed.
WorkStation of
The software breaks down. Restart the software.
Colposcope stops working.
The USB&DC cable (or USB cable) is Close the software, reconnect the cable,
loose. and restart the software.
The USB&DC cable (or USB cable) is
Replace the cable.
The image observation damaged.
area is blank screen in
white. The DC cable of the power adapter is
Fasten the cable.
loose.
The drive of the video capture card Reinstall the drive of the video capture
breaks down. card.
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The video capture card is faulty. Replace the video capture card.
The graphics card drive breaks down. Reinstall the graphics card drive.
The annular LED board is faulty. Replace the annular LED board.
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Chapter 10
Contents List
No. Part Description Quantity
3 Camera 1
6 Foot Switch 1
7 Power Adapter 1
9 Dust cover 1
10 User Manual 1
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Chapter 11
EMC Information
11.1 Guidance and manufacturer’s declaration on
electromagnetic emissions
RF emissions Group 1 The Video Colposcope uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
CISPR 11
interference in nearby electronic equipment.
RF emissions Class A
CISPR 11
Harmonic Class A The Video Colposcope is suitable for use in all establishments, other than
emissions domestic and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Voltage Complies
IEC 61000-3-2
fluctuations /
flicker emission
IEC 61000-3-3
Electrical fast ±2kV for ±2kV for Mains power quality should have a typical
transient burst Power line Power line commercial or hospital environment.
GB/T 17626.4
1 kV line(s) to
Surge 1 kV line(s) to line(s) Mains power quality should be that of a typical
line(s)
IEC 61000-4-5 2 kV line(s) to earth commercial or hospital environment.
2 kV line(s) to earth
Power frequency
85
< 5% UT < 5% UT
< 5% UT < 5% UT
for 5voltage
NOTE: UT is the a.c. mains sec for 5 sec of the test level.
prior to application
86
11.2 Guidance and manufacturer’s statement on Electromagnetic immunity
The equipment should be used under stipulated electromagnetic environment. Customer or user shall ensure
using the equipment under the following stipulated electromagnetic environment.
d 2.3 P 800M~2.5GHz
Radiated RF
IEC 61000-4-3
3 V/m
3 V/m
Note 1. At 80 MHz and 800 MHz, 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.
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
Video Colposcope is used exceeds the applicable RF compliance level above, the Video Colposcope should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Video Colposcope.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
87
The Video Colposcope is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Video Colposcope can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Video Colposcope as recommended below, according to
the maximum output power of the communications equipment.
Maximum rated output power of the Separation distance determined by the frequency of the
communications device (W) communications device (m)
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.
88
WARRANTY CERTIFICATE
BPL Medical Technologies Private Limited, warrants to the purchaser
of the equipment that it is free from all defects in material and
workmanship. BPL provides warranty for 12 months from the date of
installation or 18 months from the date of invoice whichever is earlier,
to the following equipment as per BPL warranty policy given overleaf:
OWNER/EQUIPMENT DETAILS
DATE OF INSTALLATION:
IMPORTANT NOTE:
The warranty registration card is enclosed with this user manual. The warranty will
be strictly as per BPL warranty policy given overleaf. You are requested to fill up the
warranty registration card send it to the company address given below within one
month from the date of purchase. The service provider will assist you in filling up the
form and sending the card to us. This is to ensure that the service provider is in touch
with you. Hence, properly secure the user manual having warranty card.
1. Qualification
To qualify for this warranty
a) The equipment must be purchased directly from BPL or an authorised dealer, stockist, distributor or agent and
serviced by BPL authorised dealer/service centre.
b) The warranty certificate given overleaf must be completed by the dealer or purchaser at the time of delivery of
the equipment (Read important Note overleaf).
2. Term
The term of the warranty shall be within a period of 12 months from the date of installation or 18 months from
the date of purchase/invoice, whichever is earlier to the first owner. The warranty will be valid only on receipt of
warranty registration cards by BPL within one month from the date of purchase.
Any additional warranty, if purchased is valid only after written communication from the BPL Medical Technologies
on extended warranty
4 . Extent of Warranty
This warranty is the entire written warranty given by BPL for BPL equipment and no dealer or his agent or distribu-
tor or stockist or employee is authorized to alter any terms of this warranty and no dealer or his agent or distributor
or stockist or employee is authorized to make any oral warranty on BPL’s behalf.
BPL reserves the right to add any improvements or change of design of any model at any time with no obligation
to make the same changes on units previously sold.
5. Warranty Service
To obtain warranty service, the complete equipment with accessories must be presented at the owner’s expenses
to any authorized BPL service centre. However, field service can be availed of within the Municipal limits of towns
where BPL authorized service centres are situated.
7. Limitation
This warranty shall not apply :
a) To the accessories (they are warranted for only 3 months from the date of purchase). b) To any defects caused by
misuse, negligence or insufficient care.
c) To repairs or replacement required as a result of accidents or fluctuations in AC mains supply voltage.
d) If any equipment has been modified or altered by anyone other than BPL service centre/ authorised dealer. e) If
any equipment has not been operated in accordance with the operating instructions.
f) If any equipment has been assembled, disassembled, adjusted or repaired by anyone other than an BPL Service
centre/authorised dealer.
g) If damage or deterioration has been caused by insect droppings or rat bite. h) To insignificant defects which do
not affect the function of the instrument. i) To body scratches or aesthetic defacing
INSTALLATION REPORT
CUSTOMER NAME & ADDRESS: Supplied by
(Dealer Name/Code)
Invoice /Bill No.
Date
Model Number Serial Number
INSPECTION REPORT:
PARAMETER REMARKS
AC Mains
L-N Voltage Volts
Volts
L-GND Voltage
Volts
N-GND Voltage
Stabilizer/any other
regulating device connected
Generator availability
Working condition of all the YES NO
functions
Accessories availability as YES NO
per list
Demonstration to customer YES NO
Tips on user maintenance to YES NO
the product
Details provided on after YES NO
sales service & consumables
availability
Engineer's remarks (if any)
Customer Remarks:
99
100
CUSTOMER SATISFACTION SURVEY
Model Date of
Purchase
Serial No.
1 APPEARANCE 10%
3 FEATURES 30%
4 DELIVERY 30%
Signature
1.
2.
101
104
CUSTOMER SATISFACTION SURVEY
Model Date of
Purchase
Serial No.
1 APPEARANCE 10%
3 FEATURES 30%
4 RELIABILITY 30%
Signature
1.
2.
103
106
CUSTOMER SATISFACTION SURVEY
Model Date of
Purchase
Serial No.
1 APPEARANCE 10%
3 FEATURES 30%
4 RELIABILITY 30%
Signature
1.
2.
105
106
108
SALES OFFICES
Ahmedabad : BPL Medical Technologies Pvt. Limited, 313, “ Samaan” Complex, 3rd Floor
Opp. Mansi Apt, Near Satellite Area, Ahmedabad - 380 015,
PH : 079 - 40031471
Bangalore : BPL Medical Technologies Pvt. Limited, 11th KM, Bannerghatta Road,
Arakere, Bangalore - 560 076, PH : 080-26484388 / 26484314 / 26484350
Bhopal : BPL Medical Technologies Pvt. Limited, 215, 2nd Floor, M.P.Nagar, Zone 1
Bhopal(M.P.) 462011, PH : 0755 - 4059311
Chandigarh : BPL Medical Technologies Pvt. Limited, Plot No: E-110, Industrial Area, Phase-VII,
SAS Nagar, Mohali-160055, Punjab, PH : 0172-4626572 / 4626573
Chennai : BPL Medical Technologies Pvt. Ltd, New No. 46/1, Old No. 151/1
“Archway Apartments”, Eldams Road, Teynampet, Chennai 600018,
PH : 044 -24333074
Cochin : BPL Medical Technologies Pvt. Limited, No. 35 - 261, Milma Dairy -
Methanam Road Koonamthai, Edapally North PO, Kochi-682 024,
PH : 0484-4014406/2558418
Hyderabad : BPL Medical Technologies Pvt. Limited, C/o. M/s. Crystal Marketing Corporation,
B-3, IDA Uppal, Uppal, Hyderabad – 500 039, PH : 040-27208855
Jaipur : BPL Medical Technologies Pvt. Limited, A-654 Ground floor, Royal Paradise,
Calgiri hospital road, Opp Malviya Nagar Police Station and Rungta Hospital,
Malviya Nagar, Jaipur- 302017, PH : 0141-2525933
Kolkata : BPL Medical Technologies Pvt. Limited, Shrachi Tower, 686 Anandapur, 6th Floor,
E. M. Bypass, Rubby Connector, Kolkata – 700107, PH : 033 - 23648951/ 23648952
Mumbai : BPL Medical Technologies Pvt. Limited, 207, INIZIO, Cardinal Gracious Road, Near Procter &
Gamble Plaza, Chakala Naka. Andheri (East), Mumbai: 400 099, PH: 022 - 61046000
New Delhi : BPL Medical Technologies Pvt. Limited, 304, Ashok Bhavan, 93, Nehru Place,
New Delhi - 110 019, PH : 011 - 30865001/ 30865005
Factory : BPL Medical Technologies Pvt. Limited, BPL Works, Kootupatha Junction,
Chandranagar P.O, Palakkad - 678 007, PH : 0491 - 2573100,
Tin No.32090277093
Visit us at : www.bplmedicaltechnologies.com
Contact Service Call Center on
Toll Free Number: 1800 - 425-2355
109
Our reach, quick response time
and easy availability of spares
and consumables make us more
accessible anywhere, anytime.
Always close to you
Toll Free: 1800-4252355
Head Office
Factory
© 2014 BPL Medical Technologies Private Limited. All rights reserved. BPL Medical Technologies Private Limited reserves the right to make changes in product
features, specifications, aesthetics and/or to discontinue the same at any time without notice or obligation
84