MS-8 Instructions For Use of Medical Image Processor
MS-8 Instructions For Use of Medical Image Processor
2.0
Description
Thank you for purchasing the Medical Image Processor.
Please read the Instructions for Use (hereinafter referred to as "IFU") carefully before use for
proper use of the product.
Please keep this Instructions for Use for future reference.
Legal Manufacturer Address: 401, 501, Building 4, Haizhi Technology Park, Fortis, No. 17,
Bulan Road, Xialilang Community, Nanwan Street, Longgang
District, Shenzhen, Guangdong, 518112, China
Shenzhen HugeMed Medical Technical
After-sales service company: Development Co.,Ltd.
Tel: +86-4006901290
Contact Details: E-mail: [email protected]
Website: https://hugemed.net
I
Intellectual Property
The IFU and the intellectual property of the product belong to Shenzhen HugeMed Medical
Technical Development Co., Ltd. (hereinafter referred to as "HugeMed").
© 2023 Shenzhen HugeMed Medical Technical Development Co., Ltd. All rights reserved. No
individual or organization may copy, modify, or translate the IFU, in part or in whole, without
the written consent of HugeMed.
Statement
HugeMed reserves all the rights for the final interpretation of the IFU.
HugeMed reserves the right to modify the IFU without prior notice. Modifications to the content
of the IFU will be reflected in the latest version.
HugeMed shall not be held responsible for any software and equipment not provided by
HugeMed or its distributors.
Only when all of the following requirements are met shall HugeMed be held responsible for the
safety, reliability, and performance of the product:
Assembling, expansion, adjustment, improvement, and repair shall be carried out by
professionals recognized by HugeMed;
All replaced parts involved in repair and supporting accessories and consumables are
genuine (original) parts of HugeMed or approved by HugeMed.
The related electrical equipment complies with national standards and the requirements
specified in the IFU;
This product shall be operated according to the IFU.
II
Warranty and Repair Service
The standard warranty period for this product is one year.
If the warranty period in your sales contract with the seller is inconsistent with the above
standard warranty period or unless otherwise agreed, please consult and confirm with HugeMed
through the free service hotline at +86-4006901290. If it is not confirmed by HugeMed, please
promptly negotiate and confirm with the seller.
The warranty period starts from the "Installation Date" filled in the Product Warranty Card
attached to the product, which is the only proof for calculating the warranty period. To protect
your rights and interests, please urge the installer to return the second page of the Product
Warranty Card to HugeMed within 30 days from the date of installation. If the Product Warranty
Card of the product you purchased is not returned to HugeMed in time, the warranty period will
be extended for 45 days starting from the "Ex-warehouse Date" indicated on the product
packaging box.
Within the warranty period, you may enjoy free after-sales services for the product. Please note
that HugeMed will offer a fee-based repair service even within the warranty period if the product
needs to be repaired due to the following reasons, and you need to pay for the repair and
accessories:
Artificial damage;
Improper use;
The grid voltage exceeds the voltage range specified for the product;
Force majeure;
Parts or accessories not approved by HugeMed are replaced or used, or repairs are
conducted by personnel not authorized by HugeMed; and
Other failure not arising from the product itself.
After the warranty period of the product expires, HugeMed may continue to provide fee-based
repair services. If you fail to pay for or delay the payment for the repair service, HugeMed will
temporarily suspend the repair service until you make the payment.
III
After-sales Service Unit
Customer Service Department of Shenzhen HugeMed Medical Technical Development
Co.,Ltd.
Postcode: 518112
After - sales service hotline: +86-4006901290
Sales hotline: +86-4006901290
Official website: http://hugemed.net
Warning
IV
Foreword
Description
This IFU details the purpose, functions and operation of the product. Prior to using this product,
please read carefully and understand the IFU to ensure its correct use as well as the safety of the
patient and operator.
The IFU describes this product in its most complete configuration, and some of them may not
apply to the product you have purchased. If you have any questions, please feel free to contact
this Company.
These operation instructions contain precautions on how to operate the Medical Image Processor
safely, correctly, and effectively. They help reduce failure, maintenance cost and downtime, and
improve the reliability and service life of the instrument. It can be used not only as an IFU, but
also as a reference manual. Therefore, this IFU must be kept next to the device and available at
any time.
Read Chapter 1 "Safety" carefully before using it for the first time.
Applicable Objects
The IFU is intended for use only by specially trained clinical medical staff.
Illustrations
All illustrations provided in the IFU are for reference only. The settings or data in the
illustrations may not be exactly the same as the actual display of the product.
V
Table of Contents
Description ......................................................................................................................................... I
Intellectual Property ........................................................................................................................II
Statement .......................................................................................................................................... II
Warranty and Repair Service ....................................................................................................... III
After-sales Service Unit ..................................................................................................................IV
Foreword ...........................................................................................................................................V
Table of Contents ............................................................................................................................VI
Chapter 1 Safety ................................................................................................................................1
1.1 Safety Information ................................................................................................................ 1
1.1.1 Hazard ......................................................................................................................1
1.1.2 Warning ....................................................................................................................2
1.1.3 Caution .....................................................................................................................3
1.1.4 Note ..........................................................................................................................3
1.2 Labels and Identification ...................................................................................................... 4
Chapter 2 Overview ..........................................................................................................................5
2.1 Product Description .............................................................................................................. 5
2.1.1 Intended use ............................................................................................................. 5
2.1.2 Structural Composition ............................................................................................5
2.1.3 Contraindications .....................................................................................................5
2.1.4 Product Structural Diagram .....................................................................................5
2.1.5 Battery ......................................................................................................................6
2.1.5.1 Overview ................................................................................................ 6
2.1.5.2 Battery Level .......................................................................................... 7
2.1.5.3 Battery Maintenance ...............................................................................7
2.1.5.4 Battery Recycling ................................................................................... 8
2.1.6 Clinical Benefits ...................................................................................................... 8
2.1.7 indications ................................................................................................................8
Chapter 3 Use and Maintenance ..................................................................................................... 9
3.1 Installation and Use .............................................................................................................. 9
3.1.1 Unpacking and Inspection ....................................................................................... 9
3.1.2 Charging Requirements ......................................................................................... 10
3.1.3 Environment Requirements ...................................................................................10
3.1.4 Power Supply Requirements ................................................................................. 11
3.1.5 Endoscopic Connection ......................................................................................... 11
3.1.6 Monitor (Display Device) connection ...................................................................12
3.2 Care and Maintenance ........................................................................................................ 12
Chapter 4 Operation Guide for Medical Image Processor .........................................................14
4.1 Main unit System Operation ...............................................................................................14
4.1.1 Interface Switching ................................................................................................14
4.1.2 Login Interface ...................................................................................................... 14
4.1.3 Real-time Display .................................................................................................. 15
4.1.4 File management ....................................................................................................16
VI
4.1.5 User management .................................................................................................. 17
4.1.6 Setting .................................................................................................................... 18
4.1.7 Shutdown ............................................................................................................... 20
4.2 Technical Parameters .......................................................................................................... 21
4.3 Compatible Products ...........................................................................................................22
Chapter 5 Appendix ........................................................................................................................23
5.1 Packing list ..........................................................................................................................23
VII
Chapter 1 Safety
1.1 Safety Information
This chapter lists the basic safety information that users must pay attention to and observe when
using the Medical Image Processor. Other safety information that is identical, similar, or relevant
to specific operations will appear in respective chapters.
Hazard
Indicates an urgent danger that, if not avoided, may result in death, serious physical
injury or property damage.
Warning
Indicates a potentially dangerous or unsafe operation that, if not avoided, may result
in death, serious physical injury, or property damage.
Caution
Indicates a potentially dangerous or unsafe operation that, if not avoided, may result
in minor physical injury, product failure, damage, or property damage.
Note
Stresses important precautions, provides instructions or explanations for better use
of the product.
1.1.1 Hazard
There is no such safety risk.
1
1.1.2 Warning
Warning
The Medical Image Processor shall be used in conjunction with our endoscope or
laryngoscope, and can only be used by professional clinicians, medical electrical
specialists, or trained clinical medical staff in a designated situation.
The responsible surgeon must take charge of the operating procedures and technical
application of the equipment! The trained surgeon (responsible surgeon) is entitled to
decide how to make full use of the equipment in light of the actual application
conditions.
Prior to first use, please read the IFU carefully.
Before using the Medical Image Processor, the user must check the Medical Image
Processor and its accessories to ensure their proper and safe operation.
It shall not be used in an environment where flammable or explosive items are placed
to prevent fire or explosion.
The Medical Image Processor and its supporting equipment shall be properly
installed or carried to protect the Medical Image Processor from falling, being
collided, receiving intensive oscillation, or being damaged due to other external
mechanical forces.
The electromagnetic field may affect the performance of the Medical Image
Processor and its supporting equipment, so the equipment in use near the Medical
Image Processor and its supporting products must meet the corresponding EMC
requirements, otherwise, electromagnetic interference may result in failure or
collapse to the Medical Image Processor. Mobile phones, X-ray or MRI equipment
are all possible sources of interference, all of which may emit high intensity
electromagnetic radiation.
All other devices. For example, some similar digital interference devices must meet
relevant requirements in the standards when they are connected to an Medical Image
Processor. The person responsible for connecting the equipment must ensure the
operability of the system and be responsible for meeting the system requirements. If
you have any other questions, please consult the local equipment supplier or the
technical service center of HugeMed.
Repairs or upgrades to the Medical Image Processor must be made by trained
maintenance personnel authorized by the Company.
Relevant local regulations or the hospital's regulations on waste disposal must be
followed when handling the packaging materials.
HugeMed shall not be held accountable for any personal injury and property
damage because:
2
Equipment parts are not original parts of HugeMed;
The IFU is lost;
Installation, commissioning, revision, upgrading and repair are done by personnel not
authorized by HugeMed.
HugeMed will not be responsible for any damage or incident arising from using
consumables or accessories that are not of the specifications required by HugeMed.
The main unit is prohibited from use while charging. HugeMed will not be
responsible for any damage or incident caused by unauthorized use.
A notice that any serious incident that has occurred in relation to the device should
be reported to the manufacturer and the competent authority of the Member State in
which the user and/or patient is established.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
1.1.3 Caution
Caution
The use environment and power supply of the Medical Image Processor must comply
with the requirements in Section 4.2 Technical Parameters.
1.1.4 Note
Note
Please place the IFU near the Medical Image Processor so that it is easily and
promptly accessible when required.
The IFU introduces the product in its most complete configurations and functions,
and the Medical Image Processor you have purchased may not have certain
configurations or functions.
3
1.2 Labels and Identification
Warning CE Mark
2797
Follow operating
Type BF applied part
instructions
Atmosphere pressure
Temperature limit
limitation
4
Chapter 2 Overview
2.1 Product Description
2.1.1 Intended use
This product shall be used in conjunction with the medical electronic endoscope produced by the
Company for displaying images of the in vivo operative region during endoscopic surgery.
Warning
Before using the Medical Image Processor, the user must inspect the Medical Image
Processor and its accessories to ensure their proper and safe operation.
It consists of an Medical Image Processor and accessories, which include a power cord and a
signal cable.
2.1.3 Contraindications
Used in conjunction with the electronic endoscope or laryngoscope of the Company, which is
equivalent to the contraindications of endoscope or laryngoscope.
5
[Fig. 2-2] Right front view of MS-8
2.1.5 Battery
2.1.5.1 Overview
The Medical Image Processor has a built-in lithium-ion battery (hereinafter referred to as the
"Battery") and operates on battery power. The Battery will be charged when the Medical Image
Processor is connected to the adapter. When charging in the power-on state, the Medical Image
Processor will enter the charging mode and fail to operate.
6
Note
Do not charge if the mains voltage fluctuates significantly.
Warning: MS-8 cannot be used while charging.
It takes 4–5 hours to charge the battery in full in case of running down of battery.
Rechargeable batteries have a continuous operating time of approximately 3–5 hours
with load.
If this product will not be used for a long time, please charge and discharge the
battery at a 3-month interval to avoid battery damage.
The battery belongs to consumable part and, once exhausted and failed, must be
replaced. If the battery supplies power for a too short time after it is fully charged, it
may have been damaged or failed. The power supply time of the battery depends on
the configuration and frequency of use of the Medical Image Processor, e.g.
long-time backlight of the display screen.
If the battery suffers from obvious damage (bulging, deformation, weeping) or the
battery cannot store energy, it shall be replaced and reasonably recycled.
If the battery is to be replaced, contact the distributor selling this product to you or
the manufacturer.
Replacement of battery can only be done by the technical service engineer of the
Company!
White = 20% < battery level ≤ 100% Orange = 10% < battery level ≤ 20%
Warning
Do not disassemble the battery, put it into fire or make it short-circuited. Battery
burning, explosion and leakage may cause personal injury.
2.1.7 Indications
Please refer to the Instructions for Use of the compatible HugeMed endoscope for information on
the indications for use.
8
Chapter 3 Use and Maintenance
3.1 Installation and Use
Warning
The software copyright of the Medical Image Processor is owned by the Company,
and no organization or individual is allowed to tamper, copy, or exchange it by any
means or in any form without permission.
The Medical Image Processor main unit must be connected to the endoscope or
laryngoscope manufactured by HugeMed. HugeMed shall assume no responsibility
for any damage or incident caused by connecting to endoscopes not manufactured by
HugeMed.
When the Medical Image Processor main unit is connected to energized endoscopes
or endoscope accessories not manufactured by HugeMed, leakage currents of
patients may be increased.
When the endoscope connected to the Medical Image Processor main unit loses its
function, it shall be removed from the patient immediately and disconnected from
the Medical Image Processor main unit.
Do not use this product in the presence of high-frequency electrosurgical equipment,
as it may cause injuries to patients or damage to equipment.
If the package is intact, please unpack the it correctly, carefully take out the Medical Image
Processor from the packing box, and count one by one according to the packing list. Check
whether the product has suffered from any mechanical damage and whether the items are complete.
If you have any questions, please feel free to contact the After-Sales Service Department of this
Company.
Warning
The user shall keep the packaging materials away from children. Relevant local
regulations or the hospital's regulations on waste disposal must be followed when
handling the packaging materials.
9
Note
Please keep the packing box and packaging materials for future shipping or storage.
If you open the package and find that some fittings are missing, please contact the
distributor selling this product to you or the manufacturer as soon as possible.
Specification Parameter
Output current 6A
Warning
The use environment of the Medical Image Processor shall also be free of noise, vibration, dust,
and corrosive or flammable and explosive substances.
Warning
To avoid electric shock risks, the device shall only be connected to the earthed power
supply.
When disconnecting the device from the power supply, the plug must be pulled out of
10
the wall socket.When disconnecting the Medical Image Processor from the adapter,
pull the plug out of the socket.
Warning
Please make sure that the Medical Image Processor operates under the specified
environmental and power conditions, otherwise, it will not meet the technical
specifications stated in A Product Specification and may lead to unexpected
consequences such as Medical Image Processor failure.
Note
The Medical Image Processor main unit must be connected to the endoscope or
laryngoscope manufactured by HugeMed. HugeMed shall not assume any
responsibility for any damage or incident caused by connecting to endoscopes not
manufactured by HugeMed.
Note
The plugs for the wiring of the Medical Image Processor main unit and the
endoscope have alignment marks. When inserting, pay attention to the direction of
the connector and do not forcefully insert for connection. Applying force when not
aligned may damage the plug.
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[Fig. 3-1] Diagram of Endoscope Connection
Connect the video output interface of the Medical Image Processor to the monitor with a signal
connecting line.
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Warning
Disconnect the Medical Image Processor from any main power supply, remove all
connectors, and ensure that the Medical Image Processor is totally switched off
before care and maintenance.
The main unit shell does not come into contact with the human body. After use, use a neutral
cleaning agent to disinfect its external surface.
Note
The rag shall be moist but not dripping so as not to harm the electronics inside the
display unit.
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Chapter 4 Operation Guide for Medical
Image Processor
4.1 Main unit System Operation
4.1.1 Interface Switching
Marks
(1) Regular login: Click , and a drop-down box for the user name will appear. Select the user
or call out the keyboard to enter the user name, then enter the password, and click the "Login"
button. If the user name and the password are correct, the real-time display interface will be
entered, and the login user is Admin or a regular user at this time. (Click the show/hide icon
14
to show/hide the password entered).
Remark: The default user name of Admin is admin, and the default password is 00000000;
(2) Anonymous login: Click the "Anonymous Login" button to directly enter the real-time display
interface. The login user is an anonymous user at this time, and the anonymous user cannot set
advanced options.
(2) Image adjustment: Click the Image Settings button , then drag the
button .
(3) Press the Custom button or in the upper right corner, and then select the icon to
complete the corresponding function.
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4.1.4 File management
Click on the touch screen to enter the File page, as shown in Fig. 4-3.
Then click on the corresponding date folder to enter the view image or video page, as shown in
Fig. 4-4.
Click the file thumbnail to view the file content (picture, video, graphic report), and click and
to switch files.
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(1) Image view: Click to zoom in the image, and click to zoom it out.
(2) Video view: Click to play the video, and click to pause it.
(3) File deletion: Click in the upper right corner of a file thumbnail to select the file. Once
selected, the identifier will change to . Click and to delete the selected file,
(4) File export: Connect to a USB drive, select a file and click , and the File Export pop-up
window will pop up. Select the file export format, and click to export. After the export
(5) Creation of video or graphic report: Select a picture or a video, and click Create Graphic
Report or Create Video Report to enter the Input Information interface. Input the information, and
click Create Graphic Report or Create Video Report again to generate a graphic or video report.
Click on the touch screen to enter the User page, as shown in Fig. 4-6.
Remark: Different users have different permissions. The corresponding permissions are performed
according to the login user type.
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『Fig. 4-6』User page
(1) New user: Log in as Admin, then click to enter the New User page, enter the legal user
name and password, verify the password, and click . If you can see the new user name on
the User page, the new user is successfully added.
(2) Edit user: You can edit all users when logging in as Admin; You can only edit the current user
when logging in as a regular user; You cannot edit any user when logging in as an anonymous user.
Select the user, click to enter the Edit User page, enter the legal user name and password,
verify the password, and click . If you can see the edited user name on the User page, the
user is successfully edited.
(3) Switch user: Enter the User page, select the user, click to enter the Switch User page,
enter the correct password, and click . Then the user will be switched to the currently
selected one.
(4) Delete user: Log in as Admin, select the user, and click . Click in the pop-up
window Confirm Delete to delete the selected user.
(5) Log out user: Click this button to log out the user and enter an anonymous status.
4.1.6 Setting
Click on the touch screen to enter the Settings page, as shown in Fig. 4-7.
Remark: The setting menu assigns corresponding operation permissions to different login users.
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『Fig. 4-7』Settings page
(1) Language settings: Click the Device Language bar to show the drop-down options.
Select a language, and the system language will be switched to the selected one.
(2) Data and date settings:
1) Time zone settings: Click the Time Zone Configuration bar to show the drop-down options.
Select a time zone, and the system time zone will be switched to the selected one.
2) Time system settings: Select 24H or 12H, and the time system will be switched to the selected
one.
3) Date format: Select "YYYY/MM/DD" or "DD/MM/YYYY", and the system date format will
be switched to the selected one.
4) Date and time settings: Select the date and time by sliding up and down, and click to
confirm.
(3) General settings:
1) USB Input: Switch to enable or disable exporting the file to U-disk.
2) View Rotation: Switch to enable or disable rotation button at preview window.
3) Document Access: When it is enable, all the user can access other user’s folder. When it is
disable, only admin can access other user’s folder.
4) Boot password: Click the startup password switch to control the login verification
(turn on the switch, and login verification is required for startup);
5) Pre-recording: Switch to enable or disable Patient Information Window at preview window.
When a patient ID is filled in the information, Photos and videos will be stored in the folder
with the patient's ID.
6) Border setting: Switch to change Border of preview.
7) Restore factory settings: Click the button to restore the factory settings.
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8) System upgrade: Click the button to check whether there is an upgrade file in the USB flash
drive, and click the file to upgrade the system after the administrator certification.
(4) Device information: Enter the Device Information page to view the information on the main
unit machine and lens body.
4.1.7 Shutdown
Lightly press the power button of the main unit for 3 seconds, and the power indicator light and
screen will dim, then the system will enter a shutdown state, as shown in Fig. 4-8.
Remark:
The pressing time and whether the power button pressed properly will affect the shutdown. If it
has not entered the closed state, it can be pressed for more than 3 seconds, and the maximum
pressing time should not exceed 10 seconds.
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4.2 Technical Parameters
Storage method SD card 64 GB
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4.3 Compatible Products
Reusable Ureterorenoscope
Single-use Bronchoscope
Single-use Rhinolaryngoscope
Single-use Cystoscope
Single-use Choledochoscope
Single-use Ureterorenoscope
Video Laryngoscope
22
Chapter 5Appendix
5.1 Packing list
Part name Quantity Remark
MS-8 1
Power cord 1
Power adapter 1
Instructions for use 1
HDMI to DVI cable 1
DVI to DVI cable 1 Optional
SDI cable 1 Optional
USB Flash disk(32G) 1 Optional
VL port connecting cable(type C plug to LEMO Optional
1
connector)
VL port connecting cable(type C plug to type C Optional
1
plug)
Reusable flexible endoscope connecting Optional
1
cable(Gold finger plug to LEMO connector)
23