POSDION REXTAR X Installation and operating instructions

OPERATION & SERVICE MANUAL
POSDION Co., Ltd.
Room 905, B-dong, Awish-Yedain Building, 452, Yangcheon-ro, Gangseo-gu, Seoul, 07574, Korea
Tel : [phone], Fax : [phone]
Http://www.posdion.com E-mail: [email protected]
Distributed in the USA by: GoodDrs USA
17609 Ventura Blvd. #110
Encino, CA 91316 Toll Free (844)-448-5050

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POSDION Co., Ltd.
Certificate of Warranty
Range and terms for warranty
Posdion Co., Ltd. warrants this product without any expense for the malfunctions
and faults occurring during standard transportation and operation for one(1) year
from the date of purchase. if the purchased date is not clearly confirmed,
warranty period is calculated from six months after from the date of manufacture.
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. Repairing by unauthorized person or institutes is not applied to
this warranty condition.
Requirements for after sales service
If a malfunction or fault occurs, stop using the unit immediately, and check
against the related article in this operation & service manual. Posdion Co.,Ltd. is
not responsible for indirect harm caused by the unit. Posdion Co.,Ltd. cannot
warrant for defect or harm after the warranty period.
Posdion Co.,Ltd
Disclaimer: REXTAR-X 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 Posdion Co., Ltd.,
a) injury or danger to personnel from X-ray exposure,
b) image overexposure due to poor operating techniques or procedures,
c) equipment not properly serviced or maintained in accordance with instructions contains
in this publication, and
d) equipment which has been modified or tampered with in any way.
DO NOT OPERATE THIS DEVICE UNTIL YOU HAVE READ THIS
MANUAL and reviewed the accompanying materials.
do not accept responsibility for :
GoodDrs USA, Agents or representatives,

POSDION Co., Ltd.
TABLE OF CONTENTS
Part I. OPERATION MANUAL ...........................................................................................................1
1. Basic Instructions ........................................................................................................................................ 3
2. Notes to the User ........................................................................................................................................ 6
3. Storage and Operation conditions..............................................................................................................11
4. Caution : Radioactivity............................................................................................................................... 12
5. Parts and Components.............................................................................................................................. 13
6. Specifications ............................................................................................................................................ 14
7. Name of Each parts................................................................................................................................... 20
8. Operation................................................................................................................................................... 24
9. Operating Instructions ............................................................................................................................... 27
10. How to use Battery.................................................................................................................................. 35
PART II. SERVICE MANUAL ...........................................................................................................38
1. Notes to the Users..................................................................................................................................... 38
2. Regular Maintenance ................................................................................................................................ 39
3. Block diagram............................................................................................................................................ 40
4. Error Code................................................................................................................................................. 41
5. Circuit Diagrams........................................................................................................................................ 42
Part III. Calibration Manual.............................................................................................................52
1. Basic Instruction ........................................................................................................................................ 52
SERVICE REQUIREMENTS ............................................................................................................56
11. Supplemental Safety Usage Section
........................................................................................................37AF
User Test and Certificate at the back of this User Manual.....................................................................................................................T16
*Note Updated Safety Unlock Procedure............................................................................................28

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POSDION Co., Ltd.
REXTAR-X Manual
PN# 100304-00
Rev.02
Page:1
Explanation of symbols
Refer to instruction manual/ booklet
General warning sign
Radiation exposure symbol used on operator console. Lights to indicate that an exposure
is in progress. This is accompanied by an audible tone from the console
Warning: ionizing radiation
X-ray Source Assembly, Emitting
Non-ionizing radiation
Dangerous voltage
Dangerous voltage over 1000VAC or 1500VDC.(this symbol is used inside the system.)
Warning: dangerous voltage
TYPE B APPLIED PART
Caution
Earth (ground)
Direct current
Alternating current
IPX0
Non-protected
The CE Mark is a declaration by the manufacturer that the product complies with the
requirements of the applicable European Union (EU) medical device directive and that
the product has been subject to conformity assessment procedures as provided in that
directive.
Disposal instruction
Battery state

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REXTAR-X Manual
Manufactured Date
Manufacturer’s address
European representative
Serial number
Symbol for temperature limitation
ON/OFF (POWER)

POSDION Co., Ltd.
REXTAR-X Manual
PN# 100304-00
Rev.02
Page:3
1. Basic Instructions
1) Outline
REXTAR-X is one of the POSDION battery-powered portable dental series. REXTAR-X is the
smallest and most lightweight, yet the most powerful High-Frequency X-ray device on the portable
devices market. All X-ray devices in the battery-powered portable devices series are Ripple-free HF-
type X-ray generating devices. The REXTAR-X dental-use X-ray device is perfectly designed for
medical diagnostic situations requiring ease of use and portability.
2) Features
◈ Ultra-lightweight, ultra-compact dental-use X-ray generator
◈ High frequency Toshiba Xray generator
◈ High output at 70kV / 2mA
◈ X-ray function controlled by a single button for convenience
3) Manual
This manual covers all aspects pertaining to product operation and services. The Services Manual
also offers information about the main points of installation, as well as on-site adjustment and
continuous maintenance of the device.
This manual may not take the place of education certified by a licensed department of medicine or
radiology. The following device may only be used by personnel trained in the operation and the
diagnostic use of X-ray devices.
Apart from its independent use, the following device may also be used with a portable support device
or, in conjunction with a device that may be loaded with an X-ray tube, with a table intended for X-
ray use, and a variety of similar types of diagnostic X-ray devices.
4) Attention
This manual is a guide pertaining to the safe use and operation of the REXTAR-X portable X-ray
unit. The user of the said device must receive instruction and training in the use of X-ray devices,
and may only refer to this manual in the context of said instruction. The proprietor of the REXTAR-X
portable X-ray unit has an additional obligation to receive proper instruction from regional officials
and ensure that only qualified personnel may operate this device.
There may be latent hazards associated with the use of dental electric equipment and X-ray devices
latent hazards. All users and operators of this device must be fully aware of the safety and
emergency measures and operation instructions set forth in this booklet.

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REXTAR-X Manual
Additional questions concerning safety or miscellaneous matters should be referred to the POSDION
Co., Ltd. Service Team or to the regional retailer or distributor.
Each device manufactured by POSKOM Co., Ltd. is certified to comply with
safety and health concerns by including
restraints on Xray generation in
according to United States
federal law Article J, Section 1,
Paragraph 21 and according to European Union general provision EN60601
f
or protection against radiation generated from diagnostic
devices, under IEC601-1-3.
POSDION Co., Ltd. does not accept liability for casualties or losses arising
from misuse or abuse of the REXTAR-X portable X-ray unit.
FDA 510K Cleared Device listing # K132041
it's construction
XRay

POSDION Co., Ltd.
REXTAR-X Manual
PN# 100304-00
Rev.02
Page:5
5) Caution and Warning Signs
Latent hazards may arise through improper use of X-ray devices. Such hazards are noted by warning
notices as shown below concerning crucial safety and prevention measures
※Information ※
The Operation Manual details operation procedures for the safe and
efficient use of the REXTAR-X product for X-ray technicians, radiation
technician, and other medical institutions using the REXTAR-X X-ray unit.
※CAUTION※
Failure to comply with the following safety provisions may result
in X-rays posing a danger to both the patient and the operator of
the device.

POSDION Co., Ltd.
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2. Notes to the User
1) Machinery
The central concern in the design of the REXTAR-X portable X-ray unit is your safety and
convenience. However, to better ensure your safety when operating the device, we request your
adherence to the following regulations.
This device must be operated only under the supervision of a legally qualified individual.
REXTAR-X was designed to generate radioactive rays, and cannot be used for any other purpose,
including transparency.
REXTAR-X is to be used in diagnosis only, and cannot be used for treatment purposes.
REXTAR-X has been designated as a Class II Type B device, in conformance with provisions
IEC60601-1, 2.
REXTAR-X may not be altered or manipulated at the discretion of the individual. In the case that
such changes cannot be avoided, all inquiries must be directed to the POSDION Co., Ltd. Service
Team, or to a retail center licensed for service.
REXTAR-X has been adjusted for the highest level of function. If a product should be discovered
defective, immediately turn off the device and report the incidence to the POSDION Co., Ltd.
Service Team, or to a retail center licensed for service.
REXTAR-X can be used interchangeably or in conjunction with other devices. If you should desire
to link another company’s product with REXTAR-X, inquire with the POSDION Co., Ltd. Service
Team, or to a retail center licensed for service.
Routinely use a non-acetone based disinfectant wipe (according to chemical manufacturer’s
recommendations) to disinfect the exterior surfaces of the REXTAR-X in between use on each
patient.
REXTAR-X is a maintenance-free product. However, a routine wipe-down with a disinfectant
cloth or wipe is recommended between patients, along with a quarterly visual inspection for
damage. Make sure the power is off while cleaning. Use a non-acetone based disinfectant wipe or
a cloth to wipe the exterior surfaces of the REXTAR-X.
Do not touch a patient during the operation of REXTAR-X.
DISPOSAL.
Do not use household or municipal waste collection services for disposal of
electrical and electronic equipment. EU countries require the use of separate
recycling collection services.
※CAUTION※
This device has not been waterproofed.

POSDION Co., Ltd.
REXTAR-X Manual
PN# 100304-00
Rev.02
Page:7
2) Batteries
Each country and region may have differing rules and regulations concerning the disposal of used
batteries. Disposal of batteries must follow these regional regulations.
Throwing, taking apart, or having external push are applied to batteries increases the risk of bodily
harm, as well as of fire and explosion.
Using batteries not approved by POSDION Co., Ltd. with this device increases the risk of fire and
explosion.
Batteries being stored separately must not come into contact with metal. Contact with a metal object
will provoke an excessive electrical current that will raise the temperature to such a degree that there
is risk of burns or of the battery being damaged.
.
Only battery chargers approved by POSDION Co., Ltd. may be used. Other battery chargers pose
a risk of damage to both the battery and the device.
Heating batteries or putting them near flames poses a risk of injury, or of explosion and fire.
3) Important Information for Batteries
Steps you can take to extend the life of your Lithium-
Polymer Battery.
- Charge Lithium-
Polymer batteries fully
(preferable overnight) before
beginning to use the battery
.
- Full charge and discharge Lithium-
Poly batteries 34
times to allow
the battery to reach its
maximum rated capacity.
- Use the Lithium-
Poly battery at least every 23 weeks
.
- Keep Lithium-
Poly batteries fully charged when not in use
.
- Charge Lithium-
Poly batteries regularly
.
- Avoid regularly running Lithium-
Poly batteries too low
.
- Never leave Lithium-
Poly batteries discharged for long
– the batteries do self-discharge and the
charge could drop low enough to damage the battery.
- Keep lithium-
Poly batteries out of high heat high temperatures may
cause premature battery failure
.
- Store Lithium-
Poly batteries partially
discharged in a cool,
dry place if you will not be using the battery
for several weeks.
※Caution※
Failure to properly dispose of used batteries may lead to
explosions or fire
.

POSDION Co., Ltd.
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REXTAR-X Manual
4) Measurement Uncertainty
All measurements involve certain levels of uncertainties, especially in field of EMC.
The factors contributing to uncertainties are test receiver, cable loss, antenna factor
calibration, Antenna directivity, antenna factor variation with height, antenna phase center
variation, antenna frequency interpolation, measurement distance variation, site imperfection,
mismatch, and system repeatability. Based on CISPR 16-4-2, the measurement uncertainty
level with a 95% confidence level was applied.
Conducted emission measurement (K=2, 95%)
150 ㎑ ~ 30 ㎒: +2.74 [㏈㎶]
150 ㎑ ~ 30 ㎒: -2.80 [㏈㎶]
Radiated Emission measurement(K=2, 95%)
30 ~ 200 ㎒: 10 m: +5.62 [㏈㎶/m], -5.64 [㏈㎶/m]
200 ~ 1000 ㎒: 10 m: +5.48[㏈㎶/m], -5.50 [㏈㎶/m]
Summary of Test Results
Standard
Test Item Results
Results
EN55011 2009/A1:2010
Conducted Emission
Complied
EN55011 2009/A1:2010
Radiated Emission
Complied
EN 61000-3-2:2006/A1/A2:2009
Harmonic Current
Complied
EN 61000-3-3:2008
Voltage Fluctuations and Flicker
Complied
EN 61000-4-2:2009
Electrostatic Discharge
Complied
EN 61000-4-3:2006/A2:2010
Radiated RF Immunity
Complied
EN 61000-4-4:2004/A1:2010
Electrical Fast Transient/Burst immunity
Complied
EN 61000-4-5:2006
Surge Immunity
Complied
EN 61000-4-6:2009
Conducted RF Immunity
Complied
EN 61000-4-8:2010
Magnetic Field Immunity
Complied
EN 61000-4-11:2004
Voltage dip/interruption
Complied
Performance of Criteria
General performance criteria of EN/IEC 60601-1-2, Section 36.202.1j
The equipment or system shall be able to provide the essential performance and remain safe.
The following degradations associated with essential performance and safety shall not be allowed:
• component failures;
• changes in programmable parameters;
• reset to factory defaults (manufacturer’s presets);
• change of operating mode;
• false alarms;
• cessation or interruption of any intended operation, even if accompanied by an alarm;
• initiation of any unintended operation, including unintended or uncontrolled motion, even if
accompanied by an alarm;
• error of a displayed numerical value sufficiently large to affect diagnosis or treatment;
• noise on a waveform in which the noise is indistinguishable from physiologically-produced
signals or the noise interferes with interpretation of physiologically-produced signals;
• artifact or distortion in an image in which the artifact is indistinguishable from physiologically-
produced signals or the distortion interferes with interpretation of physiologically-produced
signals;
• failure of automatic diagnosis or treatment EQUIPMENT and SYSTEMS to diagnose or treat,
even if accompanied by an alarm.

POSDION Co., Ltd.
REXTAR-X Manual
PN# 100304-00
Rev.02
Page:9
a. Conducted Emission
The AMN placed 0,8 m from the boundary of the unit under test and bonded to a
ground reference plane. This distance was between the closest points of the AMN and the EUT.
All other units of the EUT and associated equipment were at least 0,8 m from the AMN. All power was
connected to the system through Artificial Mains Network (AMN). Conducted voltage measurements on
mains lines were made at the output of the AMN.
b. Radiated Emission
Measurements were made in a 10-meter semi-anechoic chamber or Open Area Test Site that
complies to CISPR 16. Preliminary (peak) measurements were performed at an antenna to EUT
separation distance of 10 meter. The EUT was rotated 360° about its azimuth with the receive antenna
located at various heights in horizontal and vertical polarities. Final measurements (quasi-peak) were
then performed by rotating the EUT 360° and adjusting the receive antenna height from 1 to 4 m. All
frequencies were investigated in both horizontal and vertical antenna polarity, where applicable.
c. Harmonic Current
This test consists on the measurement of harmonics components of the input current which may be
produced by equipment having an input current up to and including 16 A per phase, and intended to
be connected to public low-voltage distribution systems. The equipment is tested under specified
conditions of operation.
d. Voltage Fluctuations and Flicker
The test circuit consists of a test supply voltage, reference impedance, the equipment under test and a
flicker meter compliant with IEC 60868. The equipment shall be tested in the condition in which the
manufacturer supplies it.
e. Electrostatic Discharge
The test is intended to demonstrate the immunity of equipment subjected to static electricity discharges
from operators directly and to adjacent objects. The tabletop equipment under test is placed on a wooden
table, 0.8m high, standing on the ground reference plane. A horizontal coupling plane (HCP), 1.6 x 0.8
m, is placed on the table. The EUT and the cables are isolated from the coupling plane by an insulating
support 0.5 mm thick. The floor standing equipment is isolated from the ground reference plane by an
insulating support about 0.1 m thick. The vertical coupling plane (VCP) of dimensions 0.5 m x 0.5 m is
placed parallel to, and positioned at a distance of 0.1 m from, the EUT.
f. Radiated RF Immunity
The test allows estimating of the radiated immunity of electrical and electronic equipment to
electromagnetic disturbances coming from intended radio-frequency (RF) transmitters in the frequency
range 80 MHz to 2500 MHz. The interference is applied on the enclosure of the equipment by using
transmitting antennas.
g. Electrical Fast Transient/Burst immunity
Measurements were made on a ground plane that extends 1-meter minimum beyond all sides of
the system under test. Mains power tests were conducted with the product connected to a
Coupling/Decoupling Network (CDN). I/O lines were tested in a Capacitive Coupling Clamp. One of each
unique interface was tested for a period of one (1) minute per polarity.
h. Surge Immunity
Measurements were made on a ground plane that extends 1-meter minimum beyond all sides of
the system under test. Mains power tests were conducted with the product connected to a
Coupling/Decoupling Network (CDN). I/O lines were tested in a Capacitive Coupling Clamp. One of each
unique interface was tested for a period of one (1) minute per polarity.
i. Conducted RF Immunity
Measurements were made on a ground plane that extends 0.5-meter minimum beyond all sides of the
system under test. The EUT was located 10cm above the reference ground plane and any associated
I/O cables attached to the EUT were located between 30mm and 50mm above the ground plane. The
indicated field was pre-calibrated prior to placement of the system under test.

POSDION Co., Ltd.
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j. Magnetic Field Immunity
Measurements were made on a ground plane that extends 1-meter minimum beyond sides of the system
under test. Tabletop EUT is located 80cm above the reference ground plane and floor-standing EUT is
located 10cm above the reference ground plane. The indicated field was pre-calibrated prior to placement
of the EUT under test.
k. Voltage dip/interruption
The product was subjected to voltage dips and interruptions. Testing was performed with the product
connected directly to a generator capable of simulating the voltage drops and interrupts as described.

POSDION Co., Ltd.
REXTAR-X Manual
PN# 100304-00
Rev.02
Page:11
3. Storage and Operation conditions
1) Storage
This device must NOT be stored:
◈ In direct light.
◈ In overly dusty environments.
◈ In high humidity.
◈ In poor ventilation.
◈ In highly saline environments.
◈ With chemicals or gases.
2) Operation conditions
To maintain the device’s high function and performance, avoid overly strong vibrations and maintain
the appropriate environmental conditions.
.
Conditions tolerated by the device
Temperature range
10°C ~ 30°C (50℉ ~ 86℉)
Humidity Range
30% ~ 75%RH
Atmosphere Range
700 ~ 1060hPa
Optimum operating conditions
Temperature range
17°C ~ 23°C (62.6℉ ~ 73.4℉)
Humidity Range
40% ~ 60%RH
Atmosphere Range
700 ~ 1060hPa
3) Storage and Transportation Conditions
For safe storage and transport, the device must be stored within the temperature and humidity
conditions specified below.
Conditions for Storage and transport
Temperature Range
-25°C ~ +60°C (-13℉ ~ +140℉)
Humidity Range
10% ~ 95%RH
Atmosphere Range
500 ~ 1060hPa

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4. Caution:
1) The user and/or the operator must be wearing the appropriate clothing and safety devices.
2) The user must distance himself or herself from the origin point of radiation and from secondary
exposure to radiation.
3) All unnecessary items must be removed from the vicinity of radiation.
4) Any experiments must be performed at the lowest possible value of sec (Exposure Time).
5) Care must be taken to not exceed levels of radiation designated safe for each particular site.
※CAUTION
※
Ionizing radiation may pose a significant hazard to both the
patient and the operator if safety rules are not strictly followed
※CAUTION
※
This x-ray unit may be dangerous to operator and bystander unless safe
exposure factors and operating instructions are observed.
Keep in mind that optimal radiation protection to the operator exists
within a zone of significant occupancy (the place behind the device –
60cm[Width] x 80cm[Length] x 200cm[Height]).
All personnel authorized to operate the equipment should be fully
acquainted with safety recommendations and established maximum
permissible doses.
Comply with all relevant guidelines dictated by your in-house radiation
protection program in regard to patients and operators who are
pregnant or expect to become pregnant. In implementing a radiation
protection program, please consult any state, provincial, and local
regulations governing radiation protection and the use of x-ray
equipment. Ensure proper registration and compliance with any such
regulation.
Do not use REXTAR-X until patient is positioned and ready for the

POSDION Co., Ltd.
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PN# 100304-00
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5. Parts and Components
REXTAR-X is an X-ray device for medical use. This device may be applied to diagnostic purposes, and
must be operated by a licensed dentist. The user must follow health and safety regulations relating to
electric and chemical safety, and the safeguarding of medical equipment with ionizing potential.
The REXTAR-X product is composed of 1) the REXTAR-X parts listed below.
Each and every part must be securely in its place and properly assembled for the device to operate
normally.
1) REXTAR-X main body parts
◈ High Voltage Tank, including X-ray tube
◈ Board (built-in PCB type)
◈ Battery Pack
2) REXTAR-X components parts
◈ REXTAR-X main body
◈
BackScatter safety Shield*
◈ Cone 2 (140mm)
◈ Neck-belt to be attached to the main body
◈ Hand Strap
◈ Carrying bag
◈ Operation and Service Manual
◈ Battery charger
◈ Power code
◈ Hand Switch (=Remote controller, Optional)
* Back-Scatter Shield is 12mm thick, x 6" in diameter and has a lead equivalence
of 0.5 or greater mmPb

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6. Specifications
Classifications :
Type of protection against electric shock : Class II / Internally Powered Equipment
Degree of protection against electric shock : Type B Applied part
Degree of protection against the ingress of water : IPX0
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with
oxygen or nitrous oxide
Degree of safety in the presence of a flammable anesthetics mixture with air or with oxygen or
with Nitrous oxide : Not suitable for use in the presence of a flammable anesthetics mixture with
air or with oxygen or with nitrous oxide.
Intermittent Operation : 70kV / 2mA / 1.3sec, After one exposure, 10 sec wait
Statement of reference loading conditions : 70kV / 2mA / 1.3sec
1) Device Specifications
Items
Specifications
Input
Specifications
Device Power Source
19 VDC 3.16A
Charger Power
Chicony Power Technology Co., Ltd.,
Model No.:CPA09-004A,
100-240 VAC, 50-60Hz 1.5A
Output Specifications
140 W
Device Power Source
11.1 VDC (Battery)
Battery
11.1 V (Lithium-Ion Polymer)
Frequency
70kHz
kV, mA
70 kV / 2 mA (fixed)
X-ray Exposure Time range[sec]
0.01 ~ 1.30 sec ( 43 Step )
( 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08,
0.09, 0.10, 0.12, 0.14, 0.16, 0.18, 0.20, 0.22,
0.24, 0.26, 0.28, 0.30, 0.32, 0.34, 0.36, 0.38,
0.40, 0.42, 0.44, 0.46, 0.48, 0.50, 0.55, 0.60,
0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95, 1.00,
1.10, 1.20, 1.30)
Max.
tolerance
kV
± 7%
sec
± 10%
Display
LCD Panel Display
( 3.5 Inch, BTN LCD, 1/4Duty, 1/3BIAS )
X-ray Tube
Model name
Toshiba D – 041
Inherent Filtration
Min. 1.0mm AL Eq.
Focus
0.4 mm