User’s Manual

DONG-A CHAMMED Co., Ltd.

V1 SMART MINI (CM-M-021, Rev. 4)

V1 SMART MINI
User’s Manual

-1-
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

Symbol
Table 1 Description of Symbols
Symbol Descriptions Symbol Descriptions
Degree of Protection Against
CE Mark Electric Shock; Type BF
Applied Part
Catalogue
Temperature limitation
number

Manufacturer
Humidity limitation
EU Authorized
Representative
Consult instructions for
Equipotentiality
use

Caution Fragile

Warning Keep dry

Date of Manufacturer Packing direction

Serial Number Use no hook

WEEE; Waste Electrical and

Electronic Equipmen
Please contact the
Main Power On, Off manufacturer or other
authorized disposal company
to decommission your
equipment.

Importer Medical device

Atmospheric pressure
Unique device identifier
limitation

1. Before using the device, you should familiarize yourself with this
manual
2. This manual should be placed where the user could read it
whenever necessary.

-2-
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

Name plate(Label)

- Main Body

- Packaging

- Camera
1. Camera Head 2. Camera Head
(Pen NL Type) (Pen Type)
HCHMDCMR0009-V1 HV1GTC-V1

3. Camera Head 4. Camera Head

(Gun Type 60) (Gun Type 90)
HV1SPTBC-V1 (Option) - HV1SPTAC-V1

-3-
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

Contents

Contents ............................................................................................................................................................. - 4 -
1. Introduction ................................................................................................................................................... - 5 -
1.1 Introduction .......................................................................................................................................... - 5 -
1.2 Intended purpose ................................................................................................................................. - 5 -
1.3 Features ................................................................................................................................................ - 5 -
1.4 Component ........................................................................................................................................... - 5 -
1.5 Appearance Description ....................................................................................................................... - 7 -
2.1 Caution ................................................................................................................................................. - 9 -
2.2 Warning .............................................................................................................................................. - 10 -
3.1 Installation procedure ....................................................................................................................... - 11 -
4. How to use ................................................................................................................................................... - 12 -
4.1 General operation ............................................................................................................................... - 12 -
4.2Operation stop process ........................................................................................................................ - 19 -
5. Cleaning ........................................................................................................................................................ - 20 -
5.1 Cleaning the Camera Head ................................................................................................................. - 20 -
6. Maintenance ................................................................................................................................................ - 21 -
6.1 Replacing the fuse............................................................................................................................... - 21 -
6.2 maintenance schedule ........................................................................................................................ - 21 -
7. Trouble shooting .......................................................................................................................................... - 22 -
8. Technical specification ................................................................................................................................. - 24 -
8.1 Product specification .......................................................................................................................... - 24 -
8.2 Life cycle of the product ..................................................................................................................... - 25 -
8.3 Operating principle ............................................................................................................................. - 25 -
8.4Safety device ........................................................................................................................................ - 25 -
8.5 Alarm (Information) ............................................................................................................................ - 25 -
9. Condition for use and transfer .................................................................................................................... - 26 -
9.1 Condition for use ................................................................................................................................ - 26 -
9.2 Condition for transfer / storage .......................................................................................................... - 26 -
10. Recommended Electromagnetic Environments ........................................................................................ - 27 -
11. Guidelines for After Service ....................................................................................................................... - 29 -
11.1 Policy and Warranty ......................................................................................................................... - 29 -
12. Product Approval and ................................................................................................................................ - 30 -
13. Revision history .......................................................................................................................................... - 30 -

-4-
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

1. Introduction
1.1 Introduction

The Light Source & Camera is a device that is used for patient treatment in otolaryngology, pediatrics, family
physicians. Main functions are below.

HD/FHD Resolution system.

Various Video output
2 Channel Video Input (selectable)
Video Capture (1/2/4)
Camera White Balance Function
Supports 3 modes (EAR / NOSE / LARYNGO)
Foot Switch Supported.(FULL/CAPTURE)

1.2 Intended purpose

The Light Source & Camera is a Fiberoptic Xenon Light Source plus a camera, that is a reusable, non-sterile,
active and non-invasive medical device. It is used for investigation of diseases. The time of application is
transient, meaning the duration of the examination is no longer than one hour. The patient group is not
specific. The device is used by doctors and medically trained personnel in clinics and ENT and phoniatrist
practices. The affected parts of the body are ear, nose and throat. The Light Source & Camera is used in
combination with an Endoscope.

This device is intended to be used by doctors and medically trained personnel in clinics and practices for ENT
doctors and phoniatrists.

1.3 Features

Top view

Front view Back side view

1.4 Components

-5-
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

Pen NL type Pen type Gun type(90) Gun type(60)

HV1SPTAC-V1 HV1SPTBC-V1 HV1GTC-V1 HCHMDCMR0009-V1

Foot switch HDMI Connection Power Code Camera Adapter Otoscope

Cable

-6-
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

1.5 Appearance Description

(Vertical type) (Horizontal type)

Figure 1 Front view

Table 2 Description Front view

No. Name Function

1 MAIN POWER SWITCH Power ON/ OFF switch

2 CAPTURE Capture image / Save image (with USB)

3 DIVISION 1 / 2 / 4 screen split and Live mode

4 Camera head connector Connector for connecting medical camera head

5 USB Port Port for connecting USB（For image save）

6 WB (White Balance) Operating white balance

7 FULL Expand to full screen of captured image for revision

8 CAMERA LED Camera status LED. White : Camera OFF, Green : Camera ON

-7-
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

(Vertical type) (Horizontal type)

Table 3 Description Back view

Figure 2 Back view

No. Name Function

1 Power Cable connector Connector for AC Power Cable

2 Main power switch MAIN Power ON/ OFF switch

3 Foot switch connector Connector for foot switch to capture the image

4 CVBS Output Output for camera video signal through CVBS

5 DVI Output Output for camera video signal from the camera

6 HDMI Output Output for camera video signal from the camera

7 Earth terminal A terminal to earth equipment

Figure 3 Top view

-8-
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

2. Safety Information
2.1 Caution

- The device doesn’t have water protection.

- If you notice the smell of burning, unplug the device immediately.
- Do not disassemble the device or make any modifications without authorization.
- After using the device, it should be switched off.
- DONG-A CHAMMED CO., LTD. is not liable for personal injury.
1. If no DONG-A CHAMMED part is being used.
2. if installation and operation are not performed according to DONG-A CHAMMED's
instructions
3. If alternations and extension without permission were made.

- 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 you are located.

- During moving and installation

1. Do not place flammable objects near the device
2. Do not install the device in dusty place.
3. Do not install in the place with extremely cold or hot temperature. (10C̊ ~ 40C̊)

- During cleaning
1. Clean with soft fabric by detergent or disinfectant.
2. Make sure all components and cable are not damaged before cleaning. (broken parts should
be replaced if necessary.)

-9-
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

2.2 Warning
2.2.1 General
- The device is medical devices. It must not be used for other than medical purposes.
- This device may only be operated by the physician. However, the nurse can operate it in a
subsidiary manner.
- At a minimum, service technicians and installers must have experience repairing or installing
similar medical

2.2.2 During the installation

- Make sure all the device should be connected to the proper ground.
- Please do not use non-grounded power outlets. This may result in electric shock.
- Make sure all cable are not damaged.
- A device that is sensitive to electric or magnetic fields must not be placed near this device.

2.2.3 During connecting the Power

- Do not share the socket.
- Do not pull the cable.
- Do not handle it with wet hands.
- Do not place heavy object on the cable.
- Do not extend the cable.
- Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper oper ation

2.2.4 During operating

- Do not place liquid container on the device.
- If there is thunder and lightning outside, please unplug it.
- Do not use flammable things near the device.

2 2.5 During cleaning

- Do not pour water on the device.
- Do not clean with flammable liquids.
- Main power switch must be off during cleaning.
2 2.6 During servicing
- The service technician must not repair the device while it is switched on. This may result in an
electric shock
- The service technician must ensure that the internal wiring is not damaged during repair. The
operator and the patient may receive an electric shock if the internal wiring is damaged.

- 10 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

3. Installation
3.1 Installation procedure

1. Connect the ground before connecting the power

2. Connect the AC power of the console to the power output terminal.

3. Connect one of the DVI output, HDMI output, or CVBS output of the console to the input
terminal of the display monitor.

1) Camera head connection

1. Align the cable connectors to the connector port.

2. Slide the connector until it locks into place.

Note: To unplug the camera from the console, press the locks on both sides to unlock and unplug the
camera.

- 11 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

4. How to use
4.1 General operation
4.1.1 Connect the Power cable to the product and Turn on the main switch..

4.1.2 Color of the Front Power Button LED will change to green, then wait until camera image is
output on the monitor screen.

4.1.3 Control operation

1) Auto White Balance
Touch the 'Auto White Balance' button about 2 second on the front or press the
'LED/WB' ’LED’ button on the camera head.

or

4.1.4 Screen Image

1) 'L' (Live)

This icon shows the live status, and the number behind the icon is a simple
representation to indicate the location of its image.

2) 'R' (Review)

This icon shows the review status, and the number behind the icon is a simple

- 12 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

representation to indicate the location of its image.

3) ‘F' (Freeze)

This Icon shows the Freeze status, and the number behind the icon is a simple
representation to indicate the location of its image.

4) Division (split display)

: Single Mode : Dual Mode : Quad Mode

5) ‘USB' (USB recognition indicator)

When the main unit recognizes the USB storage device, USB signal appears on the
screen. When saving an image to the storage device, the USB icon changes to red.
After the image is finished saving, it turns white.

6) ‘No Signal’ (No input signal on camera video)

When camera is not connected to the main body or when the camera's signal is not
recognized by the main unit, ‘NO SIGNAL’ signal appears on top of display\

4.1.5 Division

1) Single mode

If you press the DIVISION button, ( ) shaped icon will be changed on the upper
left of the monitor. By setting to Single Mode, only one video can be displayed on the
monitor. Four images in the order of L1 ~ L4 can be saved by pressing Capture button.

- 13 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

2) Double Mode

If you press the DIVISION button, ( ) shaped icon will be changed on the upper
left of the monitor. By setting to double Mode, two videos can be displayed on the
monitor. Two images in the order of L1 ~ L2 can be saved by pressing Capture button.

3) QUAD Mode
If you press the DIVISION button ( ) shaped icon will be changed on the upper
left of the monitor. By setting to Quad Mode, four video can be displayed on the
monitor.
Four images in the order of L1 ~ L4 can be saved by pressing Capture button.

- 14 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

4.1.6 FULL

If you press the FULL button once on saved image, the icon 'R' Review will appear on the

monitor and will display in full image depending on the mode. (Double /QUAD)

1) Single Mode

2) Double Mode

3) Quade Mode

4.1.7 How to save captured image

1) Capture
Press & hold the Capture button for few seconds to capture the image. The USB
icon on the monitor will blink in red when saving the captured image. (Folder will
be created in the USB storage device with the saved image)
◈ Image saved in the USB cannot be viewed at V1 SMART MINI. Please connect the
USB to the PC to view the saved image.

- 15 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

4.1.8 MAIN MENU

How to change settings: Press & hold the Division button to enter MAIN MENU
(After entering the menu, press each button to control; ‘Capture’: Up / ‘White Balance’:
Down / ‘Division’: Select, Exit)

1. OUTPUT VIDEO
- It is possible to change the detailed setting value of the camera image such as
brightness, sharpness etc.

- 16 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

2. DISPLAY MENU
1) RESOLUTION
Select ratio 16: 9 or 5:4 (Default: 16: 9)
Since the default aspect ratio is 16: 9, in case the circle image looks oval, it is
necessary to correct the aspect ratio setting. From the OSD MENU, enter “1.
RESOLUTION” > Change the resolution to match the monitor resolution
(1920x1080 / 1280x1024)
The reason for using this function is to forcibly adjust the aspect ratio because the
display ratio is different for each monitor.
CHAMMED Standard Monitor: 19” monitor (5: 4), 24” monitor (16:10), 27” monitor
(16: 9)
2) DUAL SCREEN SIZE
Image in DUAL Mode can be adjusted from 50 to 100% (Default: 100%)
3) DUAL LEFT-X, DUAL RIGHT-X
It is used when it is necessary to modify the X coordinate value of each image in
dual mode. (Default: 50%)

- 17 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

3. DATE/TIME MENU
- Change the time set on the device
1) DISPLAY
Time is printed at the set position (Default: OFF)
(*When saving an image to USB, the time is not saved to the image, however the
file name of the saved image is saved with the set time.)

4. SYSTEM SETTING
1) SAVE MODE
It is used for saving image automatically when capture button is pressed while the
USB is inserted. (Default: MANUAL)
2) Buzzer TIME
It is used to adjust the time the buzzer sounds when the front button is pressed.
(Default: 30)
3) LED ON TIME
Set the LED on time from 1 to 20mins. (Default: 3min)
(LED on/off: Lightly press W/B button on the front panel / white balance : Press &
hold W/B button for 2‘ sec on the front panel)
4) DEFAULT
All settings will be reset.

- 18 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

4.1.9 Firmware update

- Insert the firmware saved USB
- To enter firmware mode, press & hold the FULL button while turning on the power
- Move: CAPTURE, DIVISION button / Select: FULL button

4.2 Operation stop process

• Step1. PEN Type Camera and Gun Type Camera should return to their home position after use.
• Step2. Click the activated button on the front to turn it off.
• Step3. Turn off the main power switch on the back.

- 19 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

5. Cleaning
5.1 Cleaning the Camera Head

The camera head and cable must be cleaned prior to the first use and after every
subsequent use.

Immediately after use, unplug the camera-head connector from the console and protect it with the
soaking cap. Place the cap over the connector and turn it clockwise until secure.

Always install the soaking cap before rinsing the camera. Failure to properly
tighten the soaking cap will corrode the connector pins and void the warranty.

2. Rinse the camera head and cable in lukewarm tap water. Use a mild enzymatic detergent and a soft
brush to remove stubborn dirt and biological contaminants from all surfaces.

3. Rinse off all soap residue with water.

4. Clean glass surfaces with alcohol(ethanol).

5. Dry the camera head and cable thoroughly with a soft towel or gauze surgical sponge.

6. Prepare the camera head and cable for disinfection by rolling up the camera cable into a loop with a
diameter of about ten centimeters, avoiding kinks or twists in the cable.

- 20 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

6. Maintenance
6.1 Maintenance before & after use
1) With the power turned off, disconnect the parts connected to the device in the reverse

order of connecting them.

2) Store in a place that does not affect the device by air pressure, temperature, humidity,

ventilation, sunlight, dust, salt, and ion containing air.

3) Store in a safe place from inclination, vibration and impact.

4) Avoid places where chemicals are stored or where gas is generated.

5) Be sure to keep it clean so that it does not interfere with next use.

- Clean the exterior with a soft fabric.

- Lightly moisten the soft fabric with a mild enzymatic detergent in case of severe
contamination.
6) In case of malfunction, stop using and contact the manufacturer.

6.2 Maintenance Schedule

MIN.
SERVICE REQUIRED
FREQUENCY

Cleaning Daily

Check that all circuit board connectors and cable plugs are tight 6 monthly

Check all cable for damage or fraying 6 monthly

Inspect electrical cord 6 monthly

- 21 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

7. Trouble shooting
Table 4 Trouble shooting

Trouble Check list

Check the power cable and main power switch.
Not working
Check the cable is not damaged
Check your monitor HDMI / DVI / CVBS cable
The monitor does not display Camera cable connector connection check
Product Power On Check
The foot switch pedal does not
work Foot Switch Check cable connection.
When LED Light is not on Make sure the camera is selected.
White balance quality is poor Turn on the light source, set the camera image to
white, and perform white balance.
Camera image looks blurred Move the camera focus ring to adjust focus.
The camera image is frozen. Make sure that the camera capture feature is enabled
Dust on optical device If there is dust on the camera lens, wipe the window
with a cotton swab.

CAUTION!
1. If the device makes an unusual noise or emits smoke,
heat, or an unusual smell, immediately turn OFF the power
switch and disconnect the camera cables if they are
connected. Then, unplug the power plug from the AC power
outlet.

2. Do not disassemble or modify without permission.

- 22 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

- 23 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

8. Technical specification
8.1 Product specification
Table 5 Product specification

Specifications
No. Specification Item
V1 SMART MINI
1 Power Voltage & Frequency 100-240VAC, 50/60Hz
2 Power Consumption 80 VA
3 Control Key Electrostatic touch input method
4 Aspect Ratio 16:10 / 5:4
5 Input Resolution HD 1280x720p, FHD 1920x1080p
6 Frame Rate 50/60fps
7 Video Output 2x HDMI, 1x DVI, 1x CVBS
8 USB Port USB 2.0
9 Main Fuses 250V,2A
10 Dimension 202 ㎜(W) × 115 ㎜(D) ×780 ㎜(H) ± 10%
11 Weight 1.08Kg
Specifications
No. Specification Item
PEN / GUN Camera
1 Image Sensor CMOS
2 Image resolution HD 1280x720p, FHD 1920x1080p
3 Frame rage 50/60fps
4 Head Type Pen Type, Gun Type
5 LED Light More than 5000K
6 Weight Pen Type (400g) / Pen NL Type (350g)
/ Gun Type 60 (390g) / Gun Type 90 (400g)

- 24 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

8.2 Life cycle of the product

The service life of this product is set at 5 years, considering the specifications of the main component SMPS
and the data of the test (IEC, EN60950-1) and the approvals of TÜV Rheinland

8.3 Operating principle

When a voltage of 100-240V~ is supplied, it is divided into a primary voltage (AC 100V-240V~) and a secondary
voltage through the main board.
The primary current is supplied as current for each part and controlled by the secondary signal. When the
buttons on the front of the device are pressed, each function is activated.

The light is generated by transmitting the transformed DC current to the LED module, and the video is
transmitted through the medical camera head and displayed on the monitor.
Since the foot switch has a pause function, the image of the area that needs to be checked in detail can be
examined with a still image on the monitor.

8.4 Safety device

Power fuse (2A) are installed on main housing to protect device from electric shock.

8.5 Alarm (Information)Table 6 Alarm (Information)

No Types Cause of Occurrence Cause of restoration

1 LED Light Source About 3 minutes after LED Light You can turn on / off the LED by
operation LED Light Off. clicking the camera LED On / Off
switch.

- 25 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

9. Condition for use and transport

9.1 Condition for use
Table 7 Condition for use

Hospital Room
Ambient temperature(Device); +10℃~+40℃

Relative Humidity; below 95%

Physical
Conditions
Atmospheric pressure; 70-106 kPa.

Do not store the product in direct sunlight.

Keep away from heat

9.2 Condition for transport / storage

Table 8 Condition for transport / storage

Ambient temperature;
-20℃~+60℃

Relative Humidity; below 95%

Physical
Conditions
Atmospheric pressure; 70-106 kPa.

Do not store the product in direct sunlight.

Keep away from heat

- 26 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

10. Recommended Electromagnetic

Environments
Manufacturer’s Declaration
Refer to the following tables for specific information regarding this device’s compliance to IEC Standard 60601-
1-2:2014.
Table 9 Recommended Electromagnetic Environments

WARNING: Use of this equipment adjacent to or with other equipment should be avoided as it may result in
improper operation.
If such use is necessary, this unit and the other equipment should be observed to ensure that they are
operating normally.

- 27 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

WARNING: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the [ME EQUIPMENT or ME SYSTEM],
including cables specified by the manufacturer.

NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate protection to radio-frequency communication services. The
user might need to take mitigation measures, such as relocating or re-orienting the equipment.

- 28 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

11. Guidelines for After Service

11.1 Policy and Warranty

o DONG-A CHAMMED CO., LTD. guarantees one year warranty all new products against faults in
materials from date of shipment. This warranty covers faulty components by manufacturer.
DONG-A CHAMMED CO., LTD. will charge service fee in following cases: If the product is out
of order after the warranty expires.
o If the product is out of order due to natural disasters.
o If the product is out of order due to improper transportation after installation and careless
use.
o If the product is out of order due to improper repair or renovation.

- DONG-A CHAMMED CO., LTD. will not be responsible for any loss, damage, or injury resulting
from delay in service under this warranty.

- DONG-A CHAMMED CO., LTD. will not be responsible to you for incidental or consequential
damages of any kind arising from or connected with the use of its equipment.

- DONG-A CHAMMED CO., LTD doesn’t provide endoscope warranty. Hence, it is too easy to
broken by careless handling.

- For the A/S that occurs in foreign countries such as in EU etc, it shall be processed through the
regional agency.

- When medical accidents or recall etc happens and they are due to the inappropriateness of the
device, the producer will take the whole responsibility.

- If you need to dispose of the product, please contact DONG-A CHAMMED CO., LTD and we will
inform you of the disposal plan.

- 29 -
User’s Manual
DONG-A CHAMMED Co., Ltd.
V1 SMART MINI (CM-M-021, Rev. 4)

12. Product Approval and

Quality Assurance

- Our Visual System (model: V1 SMART MINI) is approved CE mark in accordance with Regulation
(EU) 2017/745 of Europe.

- The standards of our quality system and product are as follows;

- EN ISO 13485:2016
- KGMP(Korean Good Manufacturing Practices)

13. Revision history

Rev. No. Revision date Revision details (Applicable standard)
0 Nov. 15, 2018 Council Directive 93/42/EEC Concerning Medical Device
1 July 20, 2022 Medical Device Regulation (EU) 2017/745
2 Nov 09, 2022 Added instructions for disposal
Added guidance in case of serious incidents
Dispose of devices in accordance with valid local regulations
3 Feb. 01, 2023 Amendment due to company name change

DONG-A CHAMMED Co., Ltd.

(13Fl, b213, b214, 2804, A-Dong) 17, Gosan-ro 148beon-gil, Gunpo-si, Gyeonggi-do,
15850, REPUBLIC OF KOREA
Tel : +82-31-8068-1400 Fax : +82-31-8068-1430,
www.donga-chammed.com

Mdi Europa GmbH

Langenhagener Str. 71 D-30855 Langenhagen, Germany
Tel : +49-511-3908-9531 Fax : +49-511-3908-9539

- 30 -