VSI CLAROX plus User manual

with fully digital X-ray source based on CNT nano technology
VX-100 User Manual
plus
Ultra light
High speed driving
Wide usable
100 kV, 1 mA, 2.5 kg

V X - 100 User Manual(v01 )
2
Check the following before use;
*Troubleshooting
In instances of abnormal operation, error messages will be displayed on the Control Panel.
If a problem persists, please request assistance from the customer support information services.
E ? : An error occurred. Turn the power off, and then turn it back on. If the error persists,
contact your Service Representative.
Error Code Check
Paramete
r
Description
E1 X-ray Generator In the "E1", "E2" and "E9" states where power is
maintained, the errors related to X-ray exposure
cannot expose the X-ray.
If the equipment is turned off and on after an error
related to X-ray exposure occurs, X-ray exposure is
performed normally.
E2
E9
BATT Battery Appears when the battery voltage is lower than the
reference value during X-ray exposure. Charge the
batter
y
.
CHG Appears when foreign matter or temporary
phenomenon in the charging hole of the equipment.
Check for foreign substances and connect and
disconnect the charger.
If it continues to connect and disconnect the charger
more than 5 times, it will be performed normally.
If the error code continues to occur, contact your
service representative.
Appears when the battery is charging. After
disconnecting the battery charger from the system,
start the s
y
stem.
BATT Appears when the battery level is lower than the
reference value during X-ray exposure.
A problem occurred. Turn the power off, and then turn it back on. If the problem persists,
contact your Service Representative.
Problem Cause Solution
Equipment is not turned on. The power switch is not
turned on properly.
Turn the equipment power switch off and
then on again.
Battery discharge Charge the battery with the charger and
check again.
Battery cable is not
connected properly.
Please contact your service
representative.
Battery defect Please contact your service
representative.
Control Panel is not turned on. Defective Control Panel
board
Please contact your service
representative.
Internal cable
disconnection
Please contact your service
representative.

V X - 100 User Manual(v01 )
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No X-ray emission Exposure Switch Please contact your service
representative.
Internal cable
disconnection
Please contact your service
representative.
Defective generator Please contact your service
representative.
X-ray emission works, but
exposure is too light or
completely white.
The device is
positioned incorrectly.
Adjust the position of the equipment.
The exposure time is
too lon
g
.
Reduce the setup time.
Receptor direction
problem
Adjust the direction of receptor.
X-ray emission works, but
exposure is too dark.
The exposure time is
too short.
Increase the setting time.
* Checking for battery
1. Environment requirements for battery
(1) Storage Temperature
* Under 1 month : -10 - +45 ℃
* Under 3 month : -10 - +30 ℃
* 1 year : 25 ± 3℃
* Best Temperature : 23 ± 3℃
(2) Operating Temperature
* Charging : +10 - +45℃
* Discharging : -10 - +50℃
(3) Humidity : < 75% RH
2. Checking period for battery(Battery is a consumable component.)
-Recharge the battery every 3 months with checking the battery recharging condition.
-Recharging capacity shall be about 80%(3 level on the battery recharging indicator of control
panel) for storage.
-Recharge the battery with provided adapter within 30 mins for 80%(3 level on the battery
recharging indicator of control panel) recharging.
-Do not use the battery with liquid spillage or soaked.
-Dispose the battery according to a national law.

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Table of Contents
1. About User Manual ........................................................................................................................... 5
1.1 Cautions .................................................................................................................................... 5
1.2 Quality Assurance ..................................................................................................................... 5
1.3 Revision History ........................................................................................................................ 5
1.4 Symbols..................................................................................................................................... 5
2. Precautions ........................................................................................................................................ 6
2.1 General Cautions ................................................................................................................... 6
2.2 General Prohibitions ............................................................................................................. 6
2.3 General warnings .................................................................................................................. 6
3. Appearance and Specifications ....................................................................................................... 8
3.1 Intended Use ............................................................................................................................. 8
3.2 Specification .............................................................................................................................. 9
3.3 Safety Standards ..................................................................................................................... 10
3.4 Appearance ............................................................................................................................. 11
3.5 Dimension ............................................................................................................................... 14
3.6 Operating condition ................................................................................................................. 16
3.7 Storage and transportation condition ...................................................................................... 16
3.8 Symbols................................................................................................................................... 16
3.9 Labels of Main unit and packaging ......................................................................................... 18
3.10 Label of AC/DC adapter connector ....................................................................................... 18
3.11 Label of Radiation hazard (Physiological effects) ................................................................. 18
3.12 Label of re-chargeable battery .............................................................................................. 19
3.13 High voltage tank .................................................................................................................. 19
3.14 X-ray tube assembly ............................................................................................................. 19
4. How to use (Start-up and Shutdown procedure) ......................................................................... 20
4.1 Frequently used functions ....................................................................................................... 20
4.2 Pre-procedure ......................................................................................................................... 20
4.3 Operation procedure ............................................................................................................... 23
4.4 Storage and Cleaning after use .............................................................................................. 26
4.5 Procedure allowing measurement of the radiation quantity .................................................... 26
5. Technical Data ................................................................................................................................. 27
5.1 Specifications .......................................................................................................................... 27
5.2 X-ray exposure control ............................................................................................................ 27
5.3 X-ray tube assembly ............................................................................................................... 27
5.4 High voltage tank .................................................................................................................... 28
5.5 X-ray exposure area ................................................................................................................ 28
5.6 Re-chargeable battery ............................................................................................................. 28
5.7 AC/DC adapter Specification .................................................................................................. 28
5.8 Software for VX-100 ................................................................................................................ 28
5.9 Extra accessory ....................................................................................................................... 28
5.10 Minimum requirement for digital X-ray image receptor ......................................................... 28
5.11 Protection against Residual Radiation .................................................................................. 28
5.12 Metrics about imaging performance ...................................................................................... 28
5.13 Characteristics of the X-ray tube voltage waveform ............................................................. 29
6. Maintenance .................................................................................................................................... 30
6.1 Replacement of Rechargeable battery ................................................................................... 30
6.2 Periodic inspection (Quality Control Procedure) ..................................................................... 30
6.3 Disposal of the device ............................................................................................................. 31
6.4 Circuit diagram, component part list, etc to repair certain parts of the device ........................ 31
6.5 Assessment of the leakage and stray radiation to the operator.............................................. 31
7. Statements and tables for EMC ..................................................................................................... 32
8. Product Warranty Policy ................................................................................................................ 38

V X - 100 User Manual(v01 )
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1. About User Manual
This User Manual is provided to the user along with the VX-100.
This User Manual only pertains to the VX-100 and does not serve for any other products of the
company. In the event of loss of or damage to this User Manual, please contact to service center of
VSI Co., Ltd.
This User Manual describes the precautions and possible risks that the user should be aware of and
give attention to prior to use the VX-100. Please read carefully all the precautions before you start
using the device.
Please refer to the Table of Contents to easily find the information that you need.
If you have any inquiries or need more detail information on the product, please refer to the contact
information or call our customer service center.
1.1 Cautions
This document contains proprietary information that is protected by copyright.
Under copyright law, this document cannot be reproduced, modified or otherwise amended without
prior approval.
1.2 Quality Assurance
The contents of this document may be revised without notification.
The company will not be responsible for any consequential problems, loss or damage arising from the
use of any performance specification or information that differs from the information contained in this
User Manual.
1.3 Revision History
The part numbers and revision number indicated in this document represent the current version.
The revision number will not be changed even if any sub-documents are revised.
The revision number may be changed when there is a major change in part numbers or technical
information in the document.
1.4 Symbols
Symbols are indicated on the exterior, packaging of the product and in this User Manual.
The symbols represent important cautions and advice to the user. Please read the following symbols
carefully and be well informed of them for the use and storage of the product.
WARNING
This symbol represents “WARNING.” It is associated with possible
matters that may harm or cause irreversible damage to the product or
the patient.
CAUTION This symbol represents “CAUTION.” It is associated with possible
matters that may damage the product or harm the patient.
* This User Manual may differ from the actual product in terms of functionality.
* If deemed necessary, the company may make any improvement to the product to enhance its
performance, without prior notification, and the company has no obligation to apply the same
specification change to the products already sold.

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2. Precautions
2.1 General Cautions
CAUTIONS
1 This product is intended for use b
y
a radiolo
g
ist havin
g
received appropriate license.
2 Please read and understand the instructions carefull
y
and then use
y
ou
r
device.
3
Do not touch product, charger, and power plug with wet hands, otherwise,
there is
dan
g
er of
g
ettin
g
electrical shocks.
4
During cleaning process of product, do not use wet wiping clothes, or spray.
A
lso, please onl
y
do cleanin
g
after separatin
g
batteries from device.
2.2 General Prohibitions
PROHIBITIONS
1 Do not use with unspecified AC/DC adapter.
2 Do not use it out o
f
intended use.
3 Do not use without mountin
g
the cone.
4 Do not disassemble the device.
5 Do not use the device outside of the si
g
nificant zone of occupanc
y
.
6 Do not use on patients who known to be or possibl
y
pre
g
nant.
2.3 General warnings
WARNINGS
1
Electrical circuits inside the equipment use voltages which are capable of causing
serious injury or death from electric shock. To avoid this hazard, operators should
never remove an
y
of the cabinet covers.
2
This X-ray device is not waterproof. Water, soap, or other liquids, if allowed to drip into
the equipment, can cause electrical short circuits leading to electric shock and fire
hazards.
If liquids should accidentally spill into the system electronics, do not connect the
power cord to a supply connection or turn the system on until the liquids have dried
or evaporated completel
y
.
3
This x-ray device may be dangerous to patient and operator unless safe exposure
values are used and correct operatin
g
procedures are observed.
4
The other equipment may malfunction due to the electromagnetic waves generated
by this device. This device may malfunction due to electromagnetic interference
generated by other equipment. Do not use it adjacent to other equipment or load
other equipment do.
5
Only use the AC/DC adapter specified by the manufacturer to charge. There is a
risk of fire or explosion if unspecified AC/DC adapters are used.
And, it should be placed out of the patient's reach (outside the patient environment)
durin
g
char
g
in
g
usin
g
the AC/DC adapter.
6 Do not connect the powe
r
cord to suppl
y
mains with wet hands.
7 Do not use this device if the cone or main unit is broken or damaged. Using damaged main
unit or dama
g
ed cone ma
y
be exposed to unwanted
X
-ra
y
.
8
Always use the cone when using the device. If used without a cone, it may be
exposed to unwanted X-radiation.
9
This device must be used by the intended user. Patients and users may be at risk
from a variety of hazards when using the device by someone other than the
intended user.
10
If intentionally ignore the cautions, warnings, and safety signs specified in this manual,
patient and user ma
y
be at risk from various hazards.

V X - 100 User Manual(v01 )
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11
To prevent the device from falling down, it is necessary to hold the device with both
hands.
Using a damaged device due to falling may expose the patient or user to unwanted
X-ra
y
radiation.
12
No modification of this equipment is allowed. If the product is modified or used for any
purpose other than those specified in this User Manual, VSI will not be responsible for
the safe operation of the VX-100.
13 Please ensure not to exceed X-ra
y
exposu
r
e dose required for ima
g
e dia
g
nosis.
14
When using this device, if any abnormalities are found with the patients, please stop
usin
g
the device, and ensure the safet
y
o
f
patients.
15
While using, if you suspect of breakdowns such as oil leakage, please turn off power
immediatel
y
, and contact the closest customer support center.
16
When patients with a pacemaker are in radiograph successively, could result in
malfunction of the pacemaker.
17 Batter
y
replacement must onl
y
be carried out b
y
an authorized person.
18
When using the device, care must be taken to ensure that the cone does not come
into contact with the patient's skin.
19 This device should onl
y
be used within an X-ra
y
shieldin
g
environment.
20
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
operatin
g
normall
y
.
21
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.
22
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. Otherwise, degradation of the performance of this equipment
could result.
23 Refer to Section 7 for EMISSIONS class and
g
roup and IMMUNITY TEST LEVEL.

V X - 100 User Manual(v01 )
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3. Appearance and Specifications
This device is a portable X-ray imaging device used to diagnose by generating and controlling X-rays.
It is structured to be easily moved to other places.
This device is composed of operation panel, high voltage generator (including X-ray tube), battery, etc.
It does not include Detector, A/D Convert, image software, and computer for image output.
No. Item Qt
y
Note
1 Main uni
t
1 -
2 Cone
(
For receptor
)
1
A
ttached to main uni
t
3
A
daptor 1 -
4 User manual 1 -
5 Cradle 1 -
3.1 Intended Use
VX-100 General purpose Portable X-ray equipment is intended to be used by trained radiologist
technicians as an radiography x-ray source for producing diagnostic x-ray images using image
receptors. Its use is intended for chest X-ray imaging.
The VX-100 should be used with an X-ray detector, and this detector has a digital type and a film type.
But the X-ray detector is not included in the VX-100 package.
The owner/operator is responsible for verifying continued compliance exposure rates, leakage
radiation, alignment of the useful beam, and the calibration of kVp and mAs. Annual verification by a
qualified service technician may be required by federal law. Compliance with applicable statutory and
regulatory requirements is the responsibility of the owner/operator. Consult local, state, and/or federal
agencies regarding specific requirements and regulations applicable to the use of this type of medical
electronic equipment.
Ensure the adapter is unplugged before attempting to clean. To make sure that power is off for
VX-100 while cleaning. Use a non-alcohol based disinfectant only - wipes or a cloth dampened
with liquid or spray. Do not use acetate or acetone cleaning solutions to prevent a damage of
plastic enclosures.
VX-100 and the accompanying adaptor are not designed to be subjected to any kind of sterilization
procedure. VX-100 is not designed to be used to sterilize anything else.

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3.2 Specification
Classification Class IIb (Annex IX, Rule 10, Council Directive
93/42/EEC as amended by Directive 2007/47/EC)
Model VX-100
Protection type from electrical shock
- Class Ⅱ equipment (Charging mode)
- Internal power source equipment (Exposure
mode
)
Rated power of AC/DC adapter - Input: 100-240 Vac, 50/60 Hz, 0.4 A
- Output: 25.5 Vdc, 0.9 A
Rated power of re-chargeable battery 22.2 Vdc, 1,460 mAh
Power input 0.4 A (At charging mode)
Tube voltage 70 kV – 100 kV
(
5 kV step
)
*Loading condition
Min. 70 kV, 0.1s
Max. 100 kV, 1.0s
Tube current 1.0 mA (Fixed)
Exposure time range 0.10 s - 1.0 s
Focal spot size 0.6 mm (complied with IEC 60336)
Permanent filtration 3.5 mmAl 70kV / HVL 2.5 mmAl
Anode angle 0°
Thermal Characteristics 1.2 kJ
Maximum Anode Heat Dissipation
Rate 100 W
Mode of operation Continuous operation(Depend on duty rate)
Expected service life 5 years
Essential performance
*Accuracy of loading factors
-Tube voltage accuracy: not greater than 10 %
-Tube current accuracy: not greater than 20 %
-Exposure time accuracy: ± (10 % + 1 ms)
-Reproducibility of the radiation output: The
coefficient of variation of measured values of air
kerma: less than 0.05
Dosimetric indications
Tube
voltage
Tube
current
Exposure
time
Air Kerma
(± 20 %)
70 kV 1 mA
0.1 s 0.002 mG
y
1.0 s 0.021 mGy
100 kV 1 mA 0.1 s 0.005 mGy
1.0 s 0.054 mGy
Radiation dose delivered to the T
Tube voltage 100 kV
Tube current 1 mA
Exposure time 0.1 s(Min.) 1.0 s(Max.)
Radiation dose 0.0051 mGy 0.054 mGy

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3.3 Safety Standards
IEC 60601-
1:2005+CORR.1:2006+CORR.2:2007+A1:2012
EN 60601-1:2006+A1:2013
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-2:2014
EN 60601-1-2:2015
Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance – Collateral Standard: Electromagnetic
disturbances - Requirements and tests
IEC 60601-1-3:2008+A1:2013
EN 60601-1-3:2010
Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential
performance - Collateral Standard: Radiation
protection in diagnostic X-ray equipment
IEC 60601-1-6:2010+A1:2013
EN 60601-1-6:2010
Medical electrical equipment – Part 1-6: General
requirements for safety – Collateral standard :
usability
IEC 60601-2-28:2017
Medical electrical equipment - Part 2-28: Particular
requirements for the basic safety and essential
performance of X-ray tube assemblies for medical
diagnosis
IEC 60601-2-54:2009+A1:2015
Medical electrical equipment - Part 2-54: Particular
requirements for the basic safety and essential
performance of X-ray equipment for radiography and
radioscopy
IEC 62304:2008
EN 62304:2006+AC:2008 Medical device – Software life cycle
IEC 62366:2007+A1:2014
EN 62366:2008
Medical devices - Application of usability engineering
to medical devices

V X - 100 User Manual(v01 )
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3.4 Appearance
3.4.1 Main unit
No. Name Description
1 Cone When irradiating X-rays, limit the exposure range of the beam.
2 Maintenance port
Port used to download firmware by only authorized engineer
(
Use onl
y
with IEC 60950-1 certified PC.
)
3 Adapter connection port Port for connecting the charging adapter
4 X-ray exposure button Button to exposure X-ray
5 Control Panel Set exposure conditions and display battery charge and operation
status
6 Power button Power ON / OFF button
7 Battery cover Cover to open when replacing the battery

V X - 100 User Manual(v01 )
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3.4.2 Cradle
Name Description
Cradle Used to mount the device when not in use.
3.4.3 Wrist strap
Name Description
Wrist strap When using the device, it is used by hanging the strap on the wrist, and it
p
revents the device fallin
g
.
3.4.4 AC/DC adaptor
Name Description
AC/DC adapter It is used to charge the device, and the device cannot be operated when
charging.

V X - 100 User Manual(v01 )
13
3.4.5 Control panel
No. Name Description
1 Tube voltage
indicator Display the sett tube voltage.
2 Light field indicator The user can turn the X-ray field lamp ON/OFF and display the ON/OFF
status.
3 Battery level
indicator
The remaining battery charge is displayed in 4 stages, and in the 1st
stage, it blinks and X-rays are not irradiated.
4 Exposure time
indicator The time is set according to turn the jog dial.
5 X-ray exposure
indicator
It is displayed in green when it is ready, and in yellow when X-rays are
irradiated.
6 Jog dial Used to turn or press the dial used to set the exposure conditions.
Cone should not be placed in a direction other than patient body.

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3.5 Dimension
3.5.1 Main unit
- size: 413 mm(W) x 144 mm(D) x 284 mm(H)
- weight: 2.5 kg

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3.5.2 Cradle
- size: 305.9 mm(W) x 223.7 mm(D) x 188.2 mm(H)
- weight: 2.3 kg
3.5.3 Wrist strap
- size: 200 mm(L) X 10 mm(W)
3.5.4 AC/DC adaptor
- size: 46 mm(W) x 69 mm(D) x 70 mm(H), code length: 1840 mm

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16
3.6 Operating condition
- Temperature: +10 ℃ - +40 ℃
- Related Humidity: 30 %R.H. - 90 %R.H. (Non-condensing)
- Atmospheric pressure: 80 kPa - 106 kPa
- Altitude: Less than 2,000 m
3.7 Storage and transportation condition
- Temperature: -40 ℃ - +70 ℃
- Related Humidity: 5 %R.H. - 95 %R.H. (Non-condensing)
- Atmospheric pressure: 76 kPa - 106 kPa
3.8 Symbols
The following are descriptions of the symbols located on the outside and packaging of the product.
Please read carefully before using the product.
No Symbol Description Location
1 Serial Number Product Label
2 Date of manufacture Product Label
3 Follow instructions for use Product Label
4 Note User manual
5 General Caution, Warning (safety sign) User manual
6 Warning: Electrical Inside of equipment
7 General Prohibition (safety sign) User manual
8 Alternating current Product Label
9 Direct current Product Label
10 Keep dry Package
11 Keep away from sunlight Package

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12 EC representative Package
Product Label
13 Manufacturer Package
Product Label
14 Storage temperature range Package
Product Label
15 Storage humidity range Package
Product Label
16 Storage Atmospheric pressure range Package
Product Label
17
CE marking, Complies with European medical
devices directive
Package
Product Label
18 WEEE Mark Package
Product Label
19 Warning: Hight voltage Inside the device
20 Radiation hazard Product Label
Product enclosure

V X - 100 User Manual(v01 )
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3.9 Labels of Main unit and packaging
1) Main unit
Label location: On the Bottom of equipment
2) Packaging
Label location: On the surface of the packaging box
3.10 Label of AC/DC adapter connector
Label location: Near the AC/DC adaptor connector
3.11 Label of Radiation hazard (Physiological effects)
Label location: On the bottom right of front of the device and the surface of package

V X - 100 User Manual(v01 )
19
3.12 Label of re-chargeable battery
Label location: On the battery pack
3.13 High voltage tank
Label location: On the high voltage tank house(Inside the device)
3.14 X-ray tube assembly
Label location: On the X-ray tube assembly(Inside the device)

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20
4. How to use (Start-up and Shutdown procedure)
4.1 Frequently used functions
- Connecting “Charging cable”
- Checking “Charging condition”
- Mounting “Cone”
- Pushing “ON/OFF button”
- Setting “Exposure time”
- Setting “Tube voltage”
- Checking “Display LCD”
- Pushing “X-ray exposure button”
4.2 Pre-procedure
1) The operator of VX-100 must be a radiologist having received appropriate license.
2) Understand warnings, cautions and user manual.
3) Check the Charging condition of battery before use. If the battery is not charged enough, charge
the battery using AC/DC adapter provided by the manufacturer. (While charging mode, VX-100 could
not be used.)
Only the adapter provided by the manufacturer can be used.
The plug of adapter is used as the isolation means. Do not position the device so that it is
difficult to operate the disconnection device.
Disconnecting the plug of the AC/DC adapter from the wall power supply disconnects the
device from the mains.
The plug of the AC/DC adapter should not be installed in a place where it is difficult to
disadvantage the wall power.
Char
g
in
g
the device should be done outside of the patient environment.
4) Establish significant zone of occupancy as following and puts individual defense tool such as apron
in this area and diagnostic area in radiography.
5) When the power button is pressed for 2 seconds, check if the control panel is activated at the same
time as the beep sounds 3 times.
-The initial display value indicates the last set value.
-If there is no Jog dial and X-ray exposure button operation for 10 minutes, the power is automatically
turned off to save battery power.
6) Check that there is no error message on the exposure time display section.