1-v1) 1903
User Manual
Hand-held Dental X-ray System
XTG Model: MINIX-S
Hand-held X-ray System, XTG Model: MINIX-S User Manual
DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS MANUAL.
This manual contains installation, operation and maintenance instructions for the portable dental
X-ray system, XTG. Operation should be performed only by dentists, radiologists, dental hygienists,
or maintenance service technicians who are experienced in installing and servicing dental X-ray
systems.
DISCLAIMER: XTG is sold with the understanding that the user assumes sole responsibility for radiation
safety (as well as any state, provincial, or local regulatory compliance) and that DIGIMED Co., Ltd., its
agents or representatives, do not accept responsibility for:
a) injury or danger to personnel from X-ray exposure,
b) image over/under exposure due to poor operating techniques or procedures,
c) equipment not properly serviced or maintained in accordance with instructions contained in this
publication, and
d) equipment which has been damaged, modified, or tampered with in any way.
The Digital Doc and XTG logos are trademarks of Digital Doc LLC. DIGIMED is a trademark of DIGIMED
Co., Ltd. worldwide. All other brand and product names are trademarks or registered trademarks of
their respective companies.
The symbols used in this publication or used to mark the equipment have the following meanings:
Ionizing radiation
[STATEMENT OF COMPLIANCE]
X-RAY EQUIPMENT for DENTAL INTRA-ORAL RADIOGRAPHY XTG IEC 60601-2-65:2012
[CAUTION]
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR ON THE ORDER OF A PHYSICIAN.
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
Table of contents
1. Introduction...........................................................................................................4
1.1. Product Description ........................................................................................................4
1.2. Intended Use...................................................................................................................4
1.3. Main Features.................................................................................................................4
1.4. Definitions.......................................................................................................................4
2. Important Safety Precautions.................................................................................5
2.1. Device Package Check...................................................................................................5
2.2. Radiation Safety.............................................................................................................6
2.3. Usage and Duty Cycle..................................................................................................10
2.4. Cleaning.......................................................................................................................10
2.5. Storage and Transportation..........................................................................................10
2.6. Periodic Maintenance................................................................................................... 11
2.7. Guidance and Manufacturer’s Declaration.................................................................... 11
3. Specifications of Device.......................................................................................13
4. Components and Accessories.............................................................................14
5. Description of Device............................................................................................15
5.1. Name of Each Part........................................................................................................15
5.2. Description of the Control Panel and LCD Functions...................................................16
6. Setup and Power Check........................................................................................17
6.1. Backscatter Shield.........................................................................................................17
6.2. Remote Control Switch.................................................................................................17
6.3. Checking for Power.......................................................................................................17
7. Operation................................................................................................................18
7.1. Starting and Ending the System....................................................................................18
7.2. Indicators on LCD screen..............................................................................................18
7.3. X-ray Exposure Mode Setting .......................................................................................19
7.4. X-ray Exposure..............................................................................................................20
7.5. X-ray Exposure Techniques...........................................................................................21
8. Recommended Exposure Time Setting...............................................................22
9. Battery Handling, Charging and Maintenance....................................................23
10. Error List...............................................................................................................24
11. Instruction for Quick Start...................................................................................24
12. Technical Description..........................................................................................25
12.1. Basic Technical Specification......................................................................................25
12.2. X-ray Tube Specifications and Characteristics ...........................................................26
12.3. Distance from Focal Spot to Radiation Aperture and Diameter of X-ray Field............29
12.4. Optional Calibration Checks.......................................................................................30
12.5. Dosimetric Control......................................................................................................30
12.6. Quality Assurance.......................................................................................................31
13. Battery removal instructions..............................................................................32
14. Operator Training Test.........................................................................................33
15. Operator Training Test Answers..........................................................................36
16. Limited Warranty..................................................................................................37
17. Certificate of Training...........................................................................................38
18. Product Warranty & Registration Card...............................................................39
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
1. Introduction
This X-ray unit may be dangerous to patient and operator unless the safe exposure factors
and operating instructions are observed. To protect patient and operator from ionizing radi-
ation during X-ray generation, the device should be used with a lead apron (patient). In the
EU, the device is recommended for use with a tripod, remote hand-switch, or a mountable
arm fixture for radiation safety. Applicable US state safety requirements for radiation safety,
safety equipment, and use of hand held X-ray devices should be followed as appropriate.
1.4. Definitions
1) Lifting operation 5) Static test
A movement of unit loads consisting of goods The test during which lifting machinery or a
and/or persons necessitating, at a given mo- lifting accessory is first inspected and subject-
ment, a change of level. ed to a force corresponding to the maximum
2) Guided load working load multiplied by the appropriate
A load where the total movement is made along static test coefficient and then re-inspected
rigid or flexible guides whose position is deter- once the said load has been released to ensure
mined by fixed points. that no damage has occurred.
3) Working coefficient 6) Dynamic test
The arithmetic ratio between the load guaran- The test during which lifting machinery is
teed by the manufacturer or his authorized rep- operated in all its possible configurations
resentative up to which a component is able to at the maximum working load multiplied by
hold it and the maximum working load marked the appropriate dynamic test coefficient with
on the component. account being taken of the dynamic behavior
4) Test coefficient of the lifting machinery in order to check that it
The arithmetic ratio between the load used functions properly.
to carry out the static or dynamic tests on 7) Carrier
lifting machinery or a lifting accessory and the A part of the machinery on or in which persons
maximum working load marked on the lifting and/or goods are supported in order to be
machinery or lifting accessory. lifted.
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
Portable X-ray System, XTG User Manual
2. Important
2. ImportantSafety
SafetyPrecautions
Precautions
2.1. Device Package Check
2.1.
Unwrap
Unwrap individual
individual components
components from
from the
the protective
protective case
caseand
andcheck
checkfor
forany
anynoticeable
noticeablesigns
signsofofdamage.
dam-
The
age.standard package
The standard system
package includes
system the following
includes items:
the following items:
Power Cable
Backscatter Shield
Remote Control
Switch (Optional)
Long cone
(Optional)
Battery Charger
- Preliminary Checks
ITEM CHECK
Do not open the housing (enclosure). Do not undertake disassembly of the main apparatus, or
the warranty shall be invalidated. Repairs can be undertaken only by trained service personnel
at an authorized distributor office. Direct all questions to an authorized distributor.
- Device Label
(Model XTG)
5
6
Portable X-ray System, XTG User Manual
Hand-held X-ray System, XTG Model: MINIX-S User Manual
Incorrect placement
Correct placement
6) 6)
DoDonot
not enable
enable XTGXTGuntiluntilpatient
patient
andand operator
operator are positioned
are positioned and for
and ready ready for the exposure,
the exposure,
diminishing
diminishing the
the likelihoodofofinterruption
likelihood interruptionand
andpreventing
preventinginadvertent
inadvertentexposure
exposureofofanyone
anyonetotox-rays.
7) Dox-rays.
not attempt an exposure if anyone else is positioned immediately behind the patient (in line with
7) Do not attempt an exposure if anyone else is positioned immediately behind the patient (in line
the direction of x-ray emission). If others are assisting, then they should wear protective covering.
with the direction of x-ray emission). If others are assisting, then they should wear protective
8) When selecting
covering and using
as defined Position
in the Indicating
site radiation Devices
safety plan.(PIDs), preference should be given to models
that
8) allow
When the backscatter
selecting and usingshield to remain
Position at the
Indicating outer(PIDs),
Devices end ofpreference
the collimator cone
should befor maximum
given to
operator
modelsprotection.
that allow the operator to position the unit at the correct angle for maximum operator
protection.
6
7
Portable X-ray System, XTG User Manual
Portable
Hand-held X-ray System, XTGX-ray System,
Model: XTG User
MINIX-S Manual
User Manual
9) An exposure can be terminated for any reason by abruptly releasing the depressed trigger (for
9) 9)
AnAn exposure can bebeterminated for any reason by abruptly
abruptlyreleasing
releasingthethedepressed
depressedtrigger
trigger (for
more exposure
information,cansee terminated
Section 6.4.for any Exposure).
X-ray reason by (for
more
moreinformation,
information, see
see Section
Section 6.4.
7.4.X-ray
X-rayExposure).
Exposure).
10) As shown in the table below, maximum protection (white area) from backscatter radiation (red
10)10)
AsAs shown
shownininthethetable
tablebelow,
below, maximum (white area)
maximum protection (white area)from
frombackscatter
backscatterradiation
radiation (red
area) exists when the XTG is positioned near the patient, is perpendicular to the operator (with the
(redexists
area) area) when
exists the
when XTGtheisXTG is positioned
positioned near
near the the patient,
patient, is perpendicular
is perpendicular to the to the operator
operator (with the
patient’s
(with thehead tilted head
patient’s if needed),
tilted ifand the backscatter
needed), shield is fully
and the backscatter extended
shield is fully toward
extendedthetoward
patient and
patient’s head tilted if needed), and the backscatter shield is fully extended toward the patientthe
and
parallel
patienttoand
the parallel
operator. to the operator.
parallel to the operator.
11)11) Operationoutside
Operation outsidethe
theprotection
protection zone
zone (or
(or with
withaadiminished
diminishedprotective
protectivezone)
zone)requires proper
requires proper
11)precautions
Operation
precautionsoutside
such
such the
asas
the protection
theuse
useofoflead
leadzone (or with a diminished protective zone) requires proper
aprons.
aprons.
precautions
12)12)
DoDo
notnot
use such
use
lowlowas the
class
class use of
image
image lead aprons.
detectors.
detectors.
12) Dohigher
(Film: not
(Film: use
higher low
thanthan class
E class, image
E class,
Sensor: detectors.
Sensor:
higherhigher
thanthan 10 lp/mm,
10 lp/mm, Phosphor
Phosphor plate:
plate: higher
higher than than 10 lp/mm
10 lp/mm ) )
(Film: higher than E class, Sensor: higher than 10 lp/mm, Phosphor plate: higher than 10 lp/mm )
*Comparative Data for Whole Body Exposure (Total Annual Operator Exposures)
*Comparative Data for Whole Body Exposure (Total Annual Operator Exposures)
1
Occupational Dose Limit1 50 mSv
Occupational Dose Limit 50 mSv
1
Occupational Dose Limit Required Dosimetry1 5 mSv
Occupational Dose Limit Required Dosimetry 5 mSv
2
Average Natural Background Radiation2 3.65 mSv
Average Natural Background Radiation 3.65 mSv
3
Average Occupational Radiation Exposure for Flight Crews3 2.19 mSv
Average Occupational Radiation Exposure for Flight Crews 2.19 mSv
1
General Public Dose Limit1 1.00 mSv
General Public Dose Limit 1.00 mSv
2
Range of Exposure for Dental Personnel Using Conventional X-rays2 0.20~0.70 mSv
Range of Exposure for Dental Personnel Using Conventional X-rays 0.20~0.70 mSv
4
Average Exposure Using XTG with E-Speed Film4 0.22 mSv
Average Exposure Using XTG with E-Speed Film 0.22 mSv
4
Average Exposure Using XTG with Digital Sensor4 0.08 mSv
Average Exposure Using XTG with Digital Sensor 0.08 mSv
1) Standards for Protection Against Radiation, 10 CFR 20 (US Federal Standards), 1994
1) (see
Standards for Protection
also NCRP Against
Report No. 116) Radiation, 10 CFR 20 (US Federal Standards), 1994 Most recent publication is 1-1-08
2) (see
NCRP also NCRP
Report Report
No. No. 116)Council on Radiation Protection and Measurements), p7-9
145 (National
2)
3) NCRP Report
"Estimated No. 145
Cosmic (National
Radiation Council
Doses on Radiation
for Flight Protection
Personnel", andetMeasurements),
Feng YJ p7-9and Medical Engineering,
al, Space Medicine
3) "Estimated
15(4) 2002,Cosmic
p265-9 Radiation Doses for Flight Personnel", Feng YJ et al, Space Medicine and Medical Engineering,
15(4) 2002, average
4) Normalized p265-9 assumes 7,200 exposures per year, and the average length of exposure for
4) E-speed
Normalized average
Film = 0.20assumes
seconds,7,200
digitalexposures
sensor =per year,
0.10 and the average length of exposure for
seconds
E-speed Film = 0.20 seconds, digital sensor = 0.10 seconds
78
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
Portable X-ray System, XTG User Manual
*Comparative Data for Hand and Extremity Exposure (Total Annual Operator Exposures)
1
Occupational Dose Limit 500 mSv
1
Occupational Dose Limit Required Dosimetry 50 mSv
2
Average Exposure Using XTG with E-Speed Film 0.35 mSv
2
Average Exposure Using XTG with Digital Sensor 0.17 mSv
1) Standards for Protection against Radiation, 10 CFR 20 (US Federal Standards), 1994 (see also NCRP Report No.
116)
2) Normalized average (includes leakage and backscatter radiation) assumes 7,200 exposures per year, and the average
length of exposure for E-speed Film = 0.20 seconds, digital sensor = 0.10 seconds
8
9
Hand-held X-ray System, XTG Model: MINIX-S User Manual
XTG Model: MINIX-S requires the presence of an operator, with at least one significant zone of
occupancy with a floor not smaller than 24 inch × 24 inches wide, and not shorter than 79 inches
height, including the logical information as follows.
1) The XTG complies with International safety standards for Dental X-ray Systems which control the
level of backscatter radiation to which the operator is exposed.
2) The Zone of Significant Occupancy is defined as the area within which the operator can be standing
while operating the XTG.
3) Location of the significant zone of occupancy includes knowledge of the position of its boundaries,
and is relative to the clearly recognizable features of the XTG. This zone is significant because of
the assumed need for the operator to occupy it during an X-ray exposure.
4) Identify necessary removable protective devices required for use with the X-ray equipment and any
necessary information on their application and use.
5) The figure below shows the geometrical definition of the zone of significant occupancy (minimum)
required for safe operation of this device.
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Portable X-ray System, XTG User Manual
Hand-held X-ray System, XTG Model: MINIX-S User Manual
Portable X-ray System, XTG User Manual
Portable X-ray System, XTG User Manual
2.3.
2.3. Usage
Usage andand Duty
DutyCycle
Cycle
2.3.
2.3.
XTG Usage
XTG isUsage
and
designedand
is designed to Duty
Duty
to avoid
Cycle
anyCycle
avoid any damage
damage from from overheating.
overheating. The maximum
The maximum dutyrating
duty cycle cycle(the
rating
rela- (the
relationship
tionship
XTG between
is between
designed toduration
duration
avoidandand frequency
frequency
any of
damageoffrom exposures)
exposures) is is 1:60.
1:60.
overheating. Operator
Operator
The canrefer
can
maximum refertoto
duty below
below
cycle example
example
rating (the
XTG
chart is
chart for designed
for optimal
optimal to avoid any damage from overheating. The maximum duty cycle rating (the
use.
use.
relationship between duration and frequency of exposures) is 1:60. Operator can refer to below example
relationship between duration and frequency of exposures) is 1:60. Operator <Example
can refer toof below example
optimal use>
chart for optimal use.
chart for optimal use.
<Example of optimal use>
Duration 0.1 sec 0.25 sec 0.46 sec 0.5<Example
sec 1 sec use>
of optimal
Duration
Cycle 0.1 sec
Every 6 sec 0.2515
Every sec sec 0.4628
Every sec
sec 0.5 30
Every sec 1 sec
Duration 0.1 sec 0.25 sec 0.46 sec 0.5 secsec Every 60 sec
1 sec
Cycle Every 6 sec Every 15 sec Every 28 sec Every 30 sec Every 60 sec
Cycle Every 6 sec Every 15 sec Every 28 sec Every 30 sec Every 60 sec
• •The
Thedevice
device should
should bebe used
used with
with a tripod
a tripod or aormountable
a mountable armarm fixture
fixture for radiation
for radiation
safety
•safety bybythe
The device theEUEUrequirements.
requirements.
should be used with a tripod or a mountable arm fixture for radiation
• •XTG
The
XTG device
should
should
safety not
by the
should
not
EU bebe
used used
used
be requirements.
in in with a tripod
environments
environments orwhere
where aflammable
mountable
flammable armcleaning
cleaningfixture for
agents radiation
agents
are are
safety
present by the EU requirements.
•present
XTG should not be used in environments where flammable cleaning agents are
• •Locate
XTG should
Locate
presentthe not charger
thebattery
battery be usedaway
charger in environments
away fromthe
from thenormalwhere
normal flammable
patient
patient cleaning agents are
environment.
environment
present
• ••DLocate
o notisoperate
XTG not operated
the XTGwith insufficient
when the voltage.
voltage level is low (one bar). The proper battery
the battery charger away from the normal patient environment.
•voltage
Locate the battery
The proper for the charger
voltage rating
XTG away
for isfrom
XTG the normal
battery patient environment.
is 22.2V.
• XTG islevel
not operated withbattery ABOVE
insufficient 22.2VDC
voltage.
• •WXTG
The
is not
hen proper
the operated
battery
voltage
with insufficient
Charging Icon
rating for XTGBars voltage.
showis(1)
battery one bar the battery is Below
22.2V.
The proper voltage
recommended voltage rating
and for XTG battery
it should is 22.2V.before use.
be recharged
2.4. Cleaning
2.4.
2.4. Cleaning
Cleaning
1) Ensure the battery charger is unplugged before attempting to clean, and make sure the power is
1) turned
2.4. off
thewhile
Cleaning
Ensure cleaning.
battery charger is unplugged before attempting to clean, and make sure the power is
1) Ensure
2) Cleaning
1) Ensure the
can battery
be done charger
with aisnon-alcohol
isunplugged before
based attempting
disinfectant totoclean,
attemptingwipes, and
a cloth make
andwith sure
the the
a disinfectant power
is is
liquid,
turned off the battery
while charger
cleaning. unplugged before clean, ensure power
turned
or spray.offoff
while cleaning.
(Operators must
turned
2) Cleaning can while with abe
cleaning.
be done careful notbased
non-alcohol to dampen the device
disinfectant wipes, with any with
a cloth liquid, alcohol, or spray.
a disinfectant liquid,
2) Cleaning
Controlling
2) can be be
area done
is notwith a non-alcohol
designed to be not based disinfectant
waterproof.) wipes, a cloth withwith
a disinfectant liquid,
or Cleaning can
spray. (Operators done
mustwith
beacareful
non-alcohol tobased
dampen disinfectant
the device wipes, a cloth
with any a disinfectant
liquid, alcohol, or spray.
3) or
XTG spray.
and
liquid, or(Operators
the
spray. must bemust
accompanying
(Operators careful
battery
be not to dampen
charger
careful
Controlling area is not designed to be waterproof.) are
not to thedesigned
not
dampen device
the with
to
device any
be liquid,
subjected
with any alcohol,
by
liquid, anyorkind
spray.
alcohol, orof
Controlling
sterilization area is not
procedure. designed
XTG is to
not be waterproof.)
designed to be sterilized.
3) XTGspray.
andThe theXTG device is not battery
accompanying designed to be waterproof.)
charger are not designed to be subjected by any kind of
3) 3)
XTG XTGand
and thethe accompanying
accompanying battery charger
charger arenot notdesigned
designed to to
be be subjected by any
kindkind
of of
sterilization procedure. XTG isbattery
not designed toare be sterilized. subjected by any
sterilization
sterilization procedure.
Theprocedure. XTG is not
XTG isfor
system is rated designed
IPX
not to be sterilized.
0; do nottooperate
designed be sterilized.
the system or use battery charger if either
was immersed
The system liquidfor
is rated orIPX
subjected to operate
0; do not undue amount moisture.
the system or use battery charger if either
The system is rated for IPX 0; do not operate the system or use battery charger if either
was immersed liquid or subjected to undue amount moisture.
was immersed liquid or subjected to undue amount moisture.
2.5. Storage and Transportation
2.5.
2.5. Storage
Storage and
and Transportation
Transportation
2.5. Storage and
• Store theTransportation
unit in a place which is not affected by air pressure, temperature (cool),
humidity (dry),
unitininaventilation, sunlight, dust, salt,by sulfur,pressure,
etc. for temperature
long term storage.
• ••SStore
Please
theunit
tore the
Store the unit
be(dry), in a
careful
a place
place
place
not
which
towhich is is
which
drop or notnot
is
hitnot
the
affected
affected
affected
device air air
byduring
by pressure,
air pressure,
storage temperature
temperature
or transportation.
(cool),
(cool),
(cool),
humidity
humidity (dry), ventilation,
ventilation, sunlight,
sunlight, dust,
dust, salt,
salt, sulfur,
sulfur, etc. etc.
for for
long long
term term storage.
storage.
humidity
• Device (dry),
function ventilation,
and battery sunlight,
charging dust,
should salt,
be sulfur,
checked etc.
everyfor2-3long term
months. storage.
Pleasebe
• Please be carefulnot not to droporor hitthe
the deviceduring
during storage or or transportation.
Please becareful
careful nottotodropdrop orhit
hit thedevice
device during storage
storage or transportation.
transportation.
• ••IfDevice
your function
state requiresand storage
battery charging
of batteryshould be checked
separate from the every
X-ray 2-3
seemonths.
section 13.0.
1) TemperatureDevice function and battery charging should be checked every 2-3
conditions months.
1) Temperature conditions
Condition Storage Transportation Use
1) Temperature conditions
Condition
Temperature Storage
-20 ~ 60°C Transportation
-20 ~ 60°C Use
10-35°C
Condition Storage Transportation Use
Temperature
2) Humidity conditions -20 ~ 60°C -20 ~ 60°C 10-35°C
Temperature -20 ~ 60°C -20 ~ 60°C 10-35°C
2) Humidity conditions
Condition Storage Transportation Use
2) Humidity conditions
Condition
Percentage Storage
5-90 %RH Transportation
5-90 %RH Use
10-85 %RH
Condition Storage Transportation Use
Percentage
3) Atmospheric pressure 5-90 %RH 5-90 %RH 10-85 %RH
Percentage 5-90 %RH 5-90 %RH 10-85 %RH
3) Atmospheric pressure
Condition Storage Transportation Use
3) Atmospheric pressure
Condition
Pressure StoragehPa
800-1060 Transportation
500-1060 hPa Use hPa
800-1060
Condition Storage Transportation Use
Pressure 800-1060 hPa 500-1060 hPa 800-1060 hPa
Pressure 800-1060 hPa 500-1060 hPa 800-1060 hPa
10
11
Portable
Hand-held X-ray System, XTGX-ray System,
Model: XTG User
MINIX-S Manual
User Manual
2.6.
2.6. Periodic
Periodic Maintenance
Maintenance
ItItisisrecommended
recommendedtotomake make annual
annual maintenance
maintenance checks
checks by by a qualified
a qualified technician
technician for performance
for performance
andsafety,
and safety,asaswell
wellasas assurance
assurance of of accurate
accurate X-ray
X-ray exposure
exposure levels.
levels.
- Medical electrical equipment requires special precautions regarding EMC, and must
be installed and put in to service according to the EMC information provided in the
user manual.
- Portable and mobile RF communication equipment can effect medical electrical
equipment.
- The use of accessories other than those specified in the user manual may result in
increased emissions and void the warranty.
1)
1) Electromagnetic
Electromagnetic emissions
emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The XTG is intended for use in the electromagnetic environment specified below.
The
Theuser
XTGof the XTG shouldfor
is intended assure
use that it is electromagnetic
in the used in such an environment.
environment
specified below.
The user of the XTG should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment-guidance
11
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
Portable X-ray System, XTG User Manual
2) Electromagnetic immunity
Power frequency
1) Nominal Voltage: 230 V, 100 1) Nominal Voltage: 230 V, 100 V,
magnetic fields should be
Variation of power V, 120 V 120 V
at levels characteristic of
frequency 2) Nominal Frequency: 50 Hz, 2) Nominal Frequency: 50 Hz,
a typical location in a
IEC 60601-1 50/60 Hz, 60 Hz 50/60 Hz, 60 Hz
typical commercial or
3) Deviation: ≤1 Hz 3) Deviation: ≤1 Hz
hospital environment.
12
13
Hand-held X-ray System, XTG Model: MINIX-S User Manual
3. Specifications of Device
1) Grade ...................................................................................................................Class II b
2) Classification........................................................................................ Type B applied part
3) X-ray Generator
• Tube Voltage..............................................................................................60 kV (Fixed)
• Tube Current.............................................................................................. 2 mA (Fixed)
• High Voltage Generating Circuit.................................High Frequency Inverter Method
• X-ray Control Method.................................................... Controlled by Micro Processor
• Time Setting Range................................................. 0.01~1.0 second (0.01 sec. step)
4) X-ray Tube
• Type................................................................................. Stationary Anode X-ray Tube
• X-ray Tube Model .............................................................................. D-081B (Toshiba)
• X-ray Tube Focal Size......................................................................................... 0.8 mm
•Target Angle...............................................................................................................20°
• Total Filtration................................................................................................1.6 mm Al
(Inherent Filtration: 0.8 mm Al, Fixed Added Filtration: 1.0 mm Al)
5) Display Method................................................................................................. LCD display
6) Source to Skin Distance (SSD).................................................................................. 200 mm
7) X-ray Field...........................................................................................53 mm (Round style)
8) Weight .................................................................................................................... 1.77 kg
9) Size of Main Body...............................................................123 (W) ×220 (D) ×134 (H) mm
10) Voltage to Use
• Battery............................................................ Lithium-ion polymer battery (DC 22.2 V)
• Charge........................ (Input: 100~240VAC, 50~60Hz 1.0A / Output: DC25.2V 0.75A)
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
Portable X-ray System, XTG User Manual
4. Components of Product
The standard
standard package
package has
has following components.
the following components.
XTG Device
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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5. Description of Device
5.1. Name of each part
Front View
Side View
① Backup port
② mA measuring port
① ③ Hand Switch connection port
Bottom View
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③
② ④
① ⑤
⑧ ⑦
Control Panel
2 Adult and child display Exposure time setting differs by the patient size
Equipment operating
3 LCD displays READY when the unit is ready to expose X-ray
condition display
Incisor, canine and molar of the upper and lower jaw (Maxilla and
8 Tooth display
Mandible) display
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Portable X-ray System, XTG User Manual
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6.
6. Setup
Setup and
andPower
PowerCheck
Check
6. Setup and Power Check
6.1.
6.1. Backscatter Shield
6.1.
To Backscatter
To protect the operatorShield
the operator from
fromscattered
scatteredradiation
radiationduring
duringoperation,
operation,the
theBackscatter
BackscatterShield
Shield(More than
(More than
0.25 mm
0.25 mm lead
lead equivalent and 66 inches
inches in
indiameter) isispermanently attached and cannot be removed
To protect the equivalent andscattered
operator from diameter)
radiation during permanently attached.
operation, the This
Backscatter backscatter
Shield (Moreshield
than
or repositioned. This backscatter shield is positioned at the outer edge of the x-ray emitting cone.
is positioned
0.25 mm leadatequivalent
the outer edge
and 6ofinches
the x-ray emitting cone.
in diameter) is permanently attached. This backscatter shield
is positioned at the outer edge of the x-ray emitting cone.
6.2. Remote
6.2. Remote Control
Control Switch
Switch
6.2.
To
To Remote
activate
activate the Control
Remote
the Remote Switch
Control
Control Switch,
Switch,connect
connectthe
thehand
handswitch
switchjack
jacktotothe
theconnection
connectionport.
port.The
Thejack
jack
head should be inserted completely to the tip of the port. Press and hold the X-ray exposure button
head
To should
activate
to check beRemote
thethe inserted
function completely
Control
(beeping Switch,
sound to& the tipexposure)
connect
X-ray ofthe
thehand
port. Press
switch
from and
the jack hold
to
device.thethe X-ray
connection
X-ray exposure
exposure port. button
The
button jack
to
headcheck
should
should the function
be inserted
be pressed (beeping sound
completely
and held until the to & X-ray exposure)
the tip sound
beeping of the stops. from
port. Press the device.
andexposure
Only the X-ray
hold the button exposure
X-ray exposure button
button
on top of the
should
switch
to bethe
pressed
functions
check and(beeping
at the
function hold until
moment (Thethetrigger
sound beeping
hassound
& X-ray no stops.from
function).
exposure) Onlythe
thedevice.
exposure button
X-ray on top button
exposure of the
switch functions at the moment (The trigger has no function.).
should be pressed and hold until the beeping sound stops. Only the exposure button on top of the
switch functions at the moment (The trigger has no function.).
1718
Portable X-ray System, XTG User Manua
7.2. Indicators
Image
on LCD
7.2. Indicators screen
on LCD screen
Function Image Function
Exposure mode:mode:
Exposure
Exposure Adult Child
mode: Adult IncisorIncisor
(Upper(Upper
Canine jaw) jaw)
(Upper jaw)
Exposure mode:
Exposure
X-ray ChildisChild
mode:
exposure available CanineCanine
(Upper(Upper
jaw)
Premolar, Molarjaw)
(Upper jaw)
X-ray exposure
X-ray is available
exposure
Full charged is available
battery indicator Premolar, Molar
Premolar,
Incisor (Upper
Molar
(Lower jaw) jaw)
(Upper
jaw)
Full charged
Full battery
charged
Exposure indicator
battery
time settingindicator IncisorIncisor
(Lower(Lower
Canine jaw) jaw)
(Lower jaw)
Exposure timeFilm
Exposure
3 bars: setting
time
usesetting CanineCanine
(Lower(Lower
jaw)
Premolar, Molarjaw)
(Lower jaw)
3 bars:3
2Film
bars:use
bars: Film use plate use
Phosphor Premolar,
DualMolar
Premolar, (Lower(Lower
Molar
kV Mode jaw) jaw)
2 bars:2
1Phosphor
bars: plate
Phosphor
bar: Digital use
plate
sensor useuse Dual kV Mode
Dual kV Mode
1
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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4) Dual kV setting Note: Only applies to 70kV model (not distributed by Digital Doc, LLC)
1. Press Power-off and S button at the same time shortly.
2. Dual kV icon (D) shows on the LCD.
3. At this state, press S button for 2 seconds. (until tooth icon blinks)
4. Press Power-off button 3 times shortly.
5. LCD shows the first kV level as “110s” (Check the image)
- Operator can divide 100% of kV power into 2 levels up to 9 levels with
Up/Down control buttons.
- If the first kV level is set with 90%, next level is set with 10 %
automatically.
5. Set the kV amount for each level (1-9), and press Power-off button to
finish the setting. (Or press S button for 2 seconds.)
6. LCD shows READY.
• Press and hold Power OFF button, and then press Power ON button.
• The power turns on and all the time setting will return to the original factory setting.
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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2) Detector Positioning
• Place the edge of the X-ray emission cone at least 2 inches away
from patient skin, and focus the cone onto analog film or digital
sensor in the patient’s mouth.
(Be careful not to touch the patients’ skin)
• Press the exposure button once, and then immediately press and
HOLD the exposure button a second time.
(Once the X-ray exposure is started, the unit LED flashes red and
makes a beeping sound at the same time.)
• The user must press and hold the exposure button until the
exposure beeping sound stops. If the button is released too soon
(during the X-ray exposure), the X-ray irradiation stops and LCD
shows the error code (E04: shot time error).
• The LCD will show “READY” icon when it is ready to make next
X-ray exposure.
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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7.5.X-ray
7.5. X-ray Exposure
Exposure Techniques
Techniques
The portable X-ray system, XTG is easy to position for intraoral dental X-ray diagnosis. Since it is
The
not portable X-ray devices*,
fixed to other system, XTG is easy to degree
the exposure positionisfor intraoral
high. dental X-ray
So operators can diagnosis. Since itwhile
make exposures is not
fixed to other
the patient is device*, the exposure
sitting upright, reclined,degree
or lyingison
high.
theirSo operators
back. Ensurecanthe make
patientexposures while
is protected by athe
radiation
patient shieldupright,
is sitting (Lead apron).
reclined, or lying on their back. Ensure the patient is protected by a radiation
*The device is
shield (Lead apron). originally designed to be portable and handheld. XTG can be used with optional
stands
*The (SeeisChapter
device originally4.designed
Componentsto beofportable
Product)and handheld. XTG can be used with optional
stands (See Chapter 4. Components of Product)
1) Handheld Use
3) Device Positioning
• XTG should be positioned appropriately on the opposite side (90°)
of imaging system (intraoral digital sensor) or X-ray detecting film
(Phosphor plate) in patient’s mouth. Operators may use detector
positioner for correct X-ray exposure angle. The detectors may not
make good quality images (cone-cutting image) if the collimator
cone end is not positioned correctly.
• Exposure time may vary when X-ray exposure angle is away from
90° of image detectors (film or sensor). To have best operator
protection and low patient X-ray dose, tilt patient head (target
teeth) by the position of XTG as needed. Operators can wear or
use radiation shields (as radiation protection goggle, gloves, and
lead apron) if needed.
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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X-ray exposure time settings can be adjusted by the operator. Follow below steps for change.
1) Press S button. (The tooth icon starts to blink.)
2) Press up/down control buttons to increase or decrease the exposure time.
3) Press S button to save the adjustment and move to next tooth icon.
4) Press power off button to change the exposure mode (adult/child, image receptor setting)
Check Section 7.3. X-ray Exposure Mode Setting for more information.
5) Once the settings are all saved, the change will be maintained in memory until new adjustment or
until factory defaults are restored through the Reset Defaults. (Check Section 7.3. 5) Reset
Defaults.)
X-ray exposure time settings in this section are intended as a reference only.
Each result from X-ray imaging system may vary because of many factors.
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9. Battery
Battery Handling,
Handling,Charging
Chargingand
andMaintenance
Maintenance
1)
1) Do
Donot not make
impartany anyphysical
physicalforce force on ontothetheunit oror
unit thethebattery.
battery. If the unit or the battery is affected by
Ifany
thephysical
unit or the battery
force is affected
and modified frombyitsany physical
original shape,force
theand unitmodified from its
and its lithium ionoriginal
polymershape,
batterythe
unit
mayand not its lithiumnormally.
function ion polymer battery may not function normally
2) The high
2) high efficiency
efficiencylithium
lithiumion ion polymer
polymer battery
battery makesmakes more more
thanthan
200 200
X-raytimes of X-ray
exposures afterexposures
a full
recharging.
after full recharging.
3)
3) If the battery
If the battery chargecharge isis too
toolow,
low,LCD LCDwillshowsshowerror
errorcode
codeE01. E01. (Chapter
(Chapter 6.3)
6.3) indicating the need to
recharge
Then, the unitthe
recharge with
unititswith
battery charger.charger.
its battery
4) Full
4) Full battery
battery charge
charge takes
takes about
about 33 hours.
hours.Monitor the unit during battery recharge, and be careful not
to overcharge.
Monitor the unit during battery recharge, and be careful not to overcharge.
5) During recharge, battery charging status is displayed on the left top of LCD Screen by icon. (Battery
5) During recharge, battery charging status is displayed on the left top of LCD Screen by icon.
icon blinks)
(Battery icon blinks)
6) If the equipment is not in use for a long period of time, it is necessary to charge the battery every 3
6) Ifmonths.
the equipment
(After fullischarge,
not in use for a1long
at least time, has
exposure it is to
necessary
be made to to charge
keep thethe battery
battery once in every
functioning at its 3
months.
best.) (After full charge, at least 1 exposure has to be made to keep the battery in best function.)
7) Only use
7) Only usethe theauthorized
authorized charger
charger whichwhich is provided
is provided from the from the manufacturer
manufacturer or an authorized
or an authorized
distributor.
distributor.
8) Battery
Battery is a consumable
consumable part partand andthethebattery
batteryuse usetimetime willisdegrade
shortenedoverslowly. For best
time and/or withfunction
continued and
safety, battery pack
use, shortening should battery
the usable be replaced
life. For when its life
the best is decreased
function noticeably
of the unit and safety,at least 2 years
battery pack later
should
after thebe replaced
first when itsthe
use. Replace lifebattery
is decreased noticeably,
if duration decreases or after 2 years
by half when of use. Replace
compared new. the battery
9) Do if duration
not place decreases by half
the unit with heatwhen compared
generating new.
devices.
9) Do
Thenot placeisthe
battery unit in contact
vulnerable to heat. with heatthe
Place generating
unit where devices. The battery
air condition is vulnerable to heat.
is good.
Place the unit in a cool shaded spot out of direct sunlight.
10) Best temperature for storage and recharging is between 10~25°.
10) Best temperature for storage and recharging is between 10°C to 25°C. Operation in colder
Operation
temperatures under maycold
cause temperature
fast discharge, may and cause fast discharge.
recharging may takeAnd recharging
longer. maymay
Battery level takeindicate
longer.
Battery
lower than levelnormal
may be indicated lower than normal.
readings.
11)
11) Be Becareful
carefulwith withthethedevice
deviceand notdo to not
get get
wet.it wet. If any foreign substances and moisture come into
Iftheany
unitforeign substances
or the battery pack, and
it may moisture come into the unit or the battery pack, it may cause
cause malfunction.
12) malfunction.
There is a potential danger for an electric shock when connecting or removing the power plug to an
12) outlet.
There Do is anot touch the
potential outletfor
danger with
anwet hands
electric or make
shock when physical contact
connecting or with any conducting
removing the powerpartplugofto
the outlet.
an outlet. Do not touch the outlet with wet hands or make physical contact with conducting part of
the outlet.
• Once battery recharging is completed (charging indicator LED changes from red to
green), disconnect the DC output connector from the charger and pull out the power
connector for storage.
• For battery replacement, consult with the manufacturer or an authorized distributor.
• Risk of fire or explosion exists if the battery pack inside the device is replaced by
unauthorized service personnel.
• Properly dispose of spent or damaged battery packs.
• Return to the manufacturer or an authorized distributor for recycling.
• Do not place in municipal waste stream.
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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This error code indicates the X-ray is exposed longer than 2.2
Back up time error
sec. Please contact the authorized distributor or manufacturer.
•• Temporary
Temporary exit
exit from
from each
each code are Press
code are Press UP,
UP, DOWN
DOWN or or S button.
S button.
•• D
Doo not
not attempt
attempttotodisassemble
disassembleororamend
amendthethedevice
deviceif though
the control
the panel
controlcontinues
panel still
to showerror
shows an error
code.code.
•• Contact the
Contact the manufacturer
manufactureror oran
anauthorized
authorizeddistributor
distributorimmediately
immediatelyespecially
especiallywith
with
E02,
E02, E03
E03 oror E06
E06 errors.
error.
Power up Press the power on button for 3 seconds (until blue light turns on).
Exposure time
setting Set exposure time with up and down control buttons (△/▽).
This instruction is just for operators’ convenience only, to aid with understanding
before actual use. The XTG should not be used until after reading the manual
completely.
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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2) Classification/Specification Compliance
• MDD 93/42/EEC amended by Council Directive 2007/47/EC, Annex IX: Class II b
• IPX specification: IPX 0 (Do not operate under wet conditions.)
• Type of protection against electric shock: Internal powered device
3) Electrical
• Rechargeable lithium polymer battery: DC 22.2 V
• Maximum battery charge: DC 25.2 V
• Battery current at 2 mA, 60 kV output: 15 A
• Power supply:
- Input: AC100-240 V, 50-60 HZ 1.0 A
- Output: DC 25.2 V, 0.75 A
- Cable length of DC output: 1000 mm
- Cable length of AC input: 1700 mm
• Cable length of remote controller: 3000 mm
6) Collimator Cone
• Minimum source to skin distance: 200 mm
• X-ray field size and configuration: 53 mm diameter circle
• Radiation shielding: lead lined
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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2) General Data
The X-ray tube is especially designed for dental X-ray unit. The tube has below specification
- ELECTRICAL
• Nominal X-ray Tube Voltage (IEC60613: 2010) ------------------------------------------------------ 65 kV
• Nominal Focal Spot Value ------------------------------------------------------------------------------------- 0.8
• Nominal Anode Input Power (at 1.0s) ------------------------------------------------------------------ 600 W
• Exposure Duty Cycle --------------------------------------- 1:60 or more (Exposure time : Interval time)
- MECHANICAL
• Overall length ------------------------------------------------------------------------------------------------ 69 mm
• Max. Diameter ------------------------------------------------------------------------------------------------ 31 mm
• Target angle ------------------------------------------------------------------------------------------------------- 20˚
• Inherent filtration --------------------------------------------------- At least 0.8 mm Al equivalent at 50 kV
• X-ray coverage ------------------------------------------------------------------ 354×354 mm at SID 490 mm
• Weight ------------------------------------------------------------------------------------------------------------- 96 g
• Cooling method ----------------------------------- Oil immersed (60°C Max.) and convection oil cooling
• Tube holding -------------------------- Holding the glass envelop of the anode end and cathode end,
or the screw of the anode shank
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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Anode
cooling
curve
Anode
heating
curves
Cooling and heating curves for the anode and tube housing are equivalent to the anode
heating and cooling curves shown here.
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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200 mm
53 mm
90°
X-ray Beam
Imaging system
/Image detector
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
Portable X-ray System, XTG User Manual
Setup a calibrated Performance Meter (such as the Victoreen NERO, mAx model 8000) according to
manufacturer’s specifications to detect and report the following: X-ray Tube Voltage [kV Effective
Mode], Radiation Time [ms Effective Mode], and Dose [mR Average Mode]. The filter card for the
Test Detector should be in the 50-100kVp position.
Final performance measurements are made using a NERO mAx, model 8000 X-ray meter from
Victoreen. Tube current (mA) is sensed across a series connected resistor with an accuracy of ±1%
and measured using a digital multimeter, prior to encapsulation; XTG has no provision for external
measurement of beam current after final manufacture. Exposure time is measured during the entire
exposure; referenced to 75% rise/fall, using the NERO mAx 8000 X-ray meter. Accelerating voltage
(kV) is measured at both peak (kVp) conditions and effective conditions (kVeff), which is the
equivalent kV as if the kV were constant through the whole exposure time. Linearity is calculated per
IEC 60601-2-65, 203.6.3.1.101
This X-ray unit may be dangerous to testing technician and any bystanders
unless safe test exposure factors, such as placing the Test Detector in a lead
lined box or the use of a protective lead apron are observed.
Enable the XTG and, with the cone perpendicular to the test detector, make exposures into the Test
Detector and capture the resulting data. And compare the result with the factory release parameters
(indicated in the chart below). For results outside below tolerance limits, discontinue use and contact
your dealer/distributor or DIGIMED.
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
Step 1: Using a phillips head screw Step 2: Slide the grip panel down
driver remove the 2 screws shown and remove the panel from the
in Fig 1.0 main body of the unit as shown
in Fig 2.0 & 2.1
Fig 2.0
Fig 1.0
Fig 2.1
Step 3: Slide the battery out by gripping Step 4: Disconnect the molex connector by
the battery tag and pulling gently as depressing the tab and seperating as
shown in Fig 3.0 shown in Fig 4.0
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
1) Parents must leave the room when x-rays are taken of their child.
a. True
b. False
33
Hand-held X-ray System, XTG Model: MINIX-S User Manual
8) How would you change the radiology settings from adult to child?
a. • Press and hold the “S” button for 2 seconds
• Press the power off button once
• Press the “S” button to select child
• Press and hold the “S” button for 2 seconds
b. Press the up arrow button, the down arrow button, then press OK
c. Press the up arrow button, then press OK
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
15) What is the source to skin distance in accordance with FDA regulations?
a. A limit SSD to not less than 18 centimeters
b. A limit SSD to not less than 20 centimeters
16) The pistol grip is an accessory that is approved in my state for use.
a. True
b. False
17) This device is FDA approved and therefore we can ignore our state
requirements.
a. True
b. False
18) Does your state department have any restrictions for a handheld x-ray
device?
a. Yes
b. No
19) How do you register the XTG with the state department?
a. Call the state department and let them know you have the XTG.
b. Send a letter to the state health department on our letterhead and state that
you have the XTG.
c. Fill out an application from your state health department and send it in to
them.
20) If your state department has restrictions for XTG, please list the
restrictions.
NOTE: Answers to Questions 16-20 will varies from state to state. The
purchaser should go over their specific state requirements with their
staff/employees.
35
Hand-held X-ray System, XTG Model: MINIX-S User Manual
36
This Certifies that
Model MiniX-S
Certificate of Training
Dated
Supervising Physician
Hand-held X-ray System, XTG Model: MINIX-S User Manual
Portable X-ray System, XTG User Manual
LIMITED WARRANTY
DIGIMED Co., Ltd. (DIGIMED hereunder) warrants the portable X-ray system, XTG to
be free from any defects in material or workmanship for a period of one (1) years from
the date of purchase. (Battery: 12 months)
The liability of DIGIMED is limited repair or replacement of any parts that DIGIMED or its
authorized resellers determine to be defective. Parts proving defective will be repaired
or replaced free of charge, F.O.B. Seoul Korea (or the location of the authorized reseller),
if defective equipment is returned to such location for inspection, freight charges prepaid.
All warranty claims must be made not later than ten (10) business days following the
expiration of the applicable warranty period. Equipment repaired or replaced under
warranty will continue to be warranted for the balance of the original warranty term.
This warranty does not apply to equipment that is or has been abused, misused, or
altered (including opening enclosure or tampering), improperly maintained, subjected to
use beyond rated conditions, or damaged as a result of any carelessness or accidents.
This warranty does not cover ordinary wear and tear or maintenance.
DIGIMED makes no other warranty, either express or implied, with respect to any
equipment purchased from DIGIMED, including without limitation any implied warranties
of merchantability or fitness for a particular purpose, whether or not DIGIMED may have
been informed of the actual uses to which any of such equipment may be put. DIGIMED
shall not under any circumstance be liable for incidental, indirect, consequential, punitive
or exemplary damages, including without limitation damages for delay or lost profits, and
in no event shall liability of DIGIMED arising from the purchase, sale or use of the
equipment, or breach of any warranty made above, exceed in the aggregate the
purchase price paid therefore.
38
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Hand-held X-ray System, XTG Model: MINIX-S User Manual
Portable X-ray System, XTG User Manual
Serial number
Purchased date
Address of hospital
Phone number
Name of distributor
Product 1 years
Warranty period
Battery 12 months
RAVAGNANI DENTAL
Rua Delfim Ferreira, 580, 4100-199 Porto, Portugal
TEL: 351-229-773-040
INNODEN LLC.
212 Wells Ave S. #102
US Representative
Renton, WA 98057 USA
TEL.: 425-572-0283
FAX: 425-988-1256
39
34
Digital Doc LLC.
4789 Golden Foothill Parkway
El Dorado Hills, CA 95762
www.digi-doc.com