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OSTEOPro
Revision Date 2012. 02. 02.
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OSTEOPro
MODEL: DEXA (Dual Energy X-ray Absorptiometry)
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- Contents -
1. Warranty 3
2. Safety Observances 4
4. Product Explanation 17
5. Product Specification 21
6. Installation Method 23
7. Operating Instructions 26
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1. Warranty
1. Warranty scope and period
(1) The warranty repair service is provided free of charge for all the product failures and defects occurring
during the normal transportation and use within 1 year of purchase.
(2) The prescribed service charge is claimed after the following repairs.
- The failure after the warranty period is over.
- The failure caused by the natural disasters such as fires, earthquakes, lightning’s, floods, and so on.
- The failure caused by the improperly moving and negligently using the product after installation.
- The failure caused by the repair or remodeling work done by the person who is not the designated
service staff.
(3) The exterior defect or damage that is irrelevant to the major functions of the product is not repaired free
of charge.
(1) Suspend the use in failure and double-check the details of the operating manual.
(2) Turn off the product before a repair request, check the model name, product serial number, and
purchase date, and contact the designated service location.
NOTE equipment. We are not responsible for the damage and injury after the given warranty
period. The warranty has priority over the warranty to guarantee detailed suitability
and the other warranties to guarantee the product.
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2. Safety Observances
Please read the manual before using the B.M.Tech Worldwide X-ray system. The manual includes the
information on the X-Ray system and on the accessories. It should be used by the experienced medical
specialist or radiologist who can use the equipment.
[Terminology]
WARNING provides the information on the dangers possibly causing the serious injury
WARNING
or death or considerable material property loss if the warning is ignored.
CAUTION provides the information on the dangers including the light injury or material
CAUTION
property loss possibly occurring if the warning is ignored.
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1. General Matters
The equipment is categorized as a Type B Class I machine. Observe the following caution for safety.
CAUTION
- The equipment must be handled by a qualified staff (an experienced medical specialist or a radiologist).
- Always put the operating manual beside the equipment and be well-informed of the operation method
and safety.
- Observe the matters stated in the manual for the safe use of the equipment. We are not responsible for
the equipment damage or patient injury caused by the inexperience in operation.
- If there is a problem with the equipment, turn off the power to make a repair request.
- The technical specialist qualified by B.M.Tech Worldwide should maintain, repair, and fix the equipment.
The safety may not be guaranteed if a non-qualified staff handles it.
2. Electrical Safety
WARNING
- Never open up the safety cover of the equipment. The dangerous voltage is flowing inside the
equipment.
- Never use the equipment in the place where flammable or narcotic gas is around. There is a danger of
explosion.
- Always inspect the equipment before use to prevent the danger of electric shock. Check the exterior of
the equipment and the cables. If a crack on the surface, breakage, damaged exterior, or a worn-out cable
is found, stop using it and make a repair request.
- Always unplug the cord while cleaning the equipment to prevent the danger of electric shock.
- Power should be connected to the earth socket for safety.
- Please inspect and use the system power cord and plug to prevent an electric shock or a fire. Be careful
not to have them damaged.
- Do not contact the signal I/O part of the equipment and a patient at the same time. It may cause the
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leakage current.
CAUTION
- The equipment is the product passing the EMI standard. However, the use of the product in the
electromagnetic field may cause the equipment damaged. If the quality of the X-ray image is noticeably
low or bad, B.M.Tech Worldwide recommends the procedure of checking if there is the source of the
electromagnetic wave radiated in the environment where the system is used. the electromagnetic
radiation may occur in the same or close space. For example, the cell phone, beeper, radio, TV, or
microwave oven is the cause of occurrence of the electromagnetic wave. If the electromagnetic wave
interferes with the system, move the system to the place where it is separated from EMI.
3. Equipment Protection
CAUTION
- Tying or twisting much the cable connected to a patient may cause the system shutdown or malfunction.
- The incorrect cleaning or disinfection of the part connected to a patient may be dangerous. As for the explanation
on the cleaning or disinfection, please refer to the manual on "Maintenance & Storage".
- Do not put the cable of the part connected to a patient in liquid. The cable is not waterproof.
- Do not use the solvent such as thinner, benzene, and so on for a system or peripheral device.
4. Radiation Safety
WARNING
- The X-ray equipment should be used properly to prevent a patient or user from being in danger.
- The sufficient protection equipment should be worn before using the equipment.
- We are not responsible for the excessive exposure due to the incorrect use of the equipment.
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- Be careful of the safety state such as slope, vibration, impact (including the transportation), and so on.
- Do not install it in the place where chemicals are stored or gas occurs.
- Clean, arrange, and collect accessories, cords, catheters, and so on
- Be sure to clean the equipment for the next use without problems.
(6) Properly represent the equipment failures and have a specialist do the repair work.
(9) The size of the room using the equipment should be 3mx3m or bigger.
(10) The master switch of the equipment shouldn't be turned off while an X-ray is being emitted.
(11) When the equipment is connected to the computer with the RS232 cable, the power of two equipments
should be turned off.
(12) The target that is not to be measured shouldn't be included in the scan area.
(14) The obstacle affecting the movement of the equipment shouldn't be around.
(15) If an emergency occurs during the irradiation of an X-ray, press the red Emergency Stop button to stop
the equipment.
(16) The sufficient training should be provided through the equipment operating manual and through the
training in the main office. It should be used only by the person with the knowledge on the correct use of the
equipment.
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(17) Due to the interference caused by the irradiation of an electromagnetic device while the system is
operating, the following people are prohibited from using the equipment.
- The person using a heartbeat control device
- A pregnant woman
(18) An X-ray shouldn't be used in the room or area with the risk of explosion.
(19) A user should acquire the details of "The Rules on the Safety Control of the Device Generating the X-
Ray for Diagnosis" of the Ministry of Health and Welfare Ordinance to correctly use the X-ray.
(20) The equipment is used in the well-ventilated environment that has the temperature with 15 to 40 °C
and the relative humidity with 20 to 80%.
(21) The device should be installed in the flat place with the strong foundation and shouldn't be installed in
the place where a lot of dust, the serious vibration, and a lot of electromagnetic waves are around.
(23) Even though the equipment is not used for a while, the equipment is operated once a month to check if
it operates normally.
(24) Miscellaneous
It should be operated correctly according to the operating manual.
WARNING
If the continuous X-ray beam with the pulse shape is radiated on the implanted part of an implantable
pacemaker or defibrillator, the devices may cause the improper malfunction so that the X-ray beam
should be prevented from being directly radiated on the pacemaker or defibrillator and the X-ray output
should be set up for use at minimum for a short period.
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6. Symbols
International Electro technical Commission (IEC) enacted the representation of safety and information on
medical electronic equipment. The enacted representation is as follows.
Earth (Ground)
Dangerous Voltage
Shooting
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7. Label
“CAUTION”
If you look at the laser aperture directly without any protective device when using laser, your eyes may be
seriously damaged.
“WARNING”.
If your finger or other body parts are put between the moving x-ray machine and the patient table, an
accident may occur.
When using the OSTEOPro equipment, you are advised to use it within the designated temperature range
to protect the inserted tube and to abide by the appropriate temperature range of use and the error of
measurement.
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- OSTEOPro is the equipment generating an X-ray and measuring the patient's spine, femoral (Femur) and
forearm region with the movement through the motor driving. Due to the motor movement, a person to be
examined or a user should use the safety caution.
- Leaning on the equipment arm or touching the moving equipment while being in the waiting or measuring
state may cause a safety problem.
- If power is turned on, the equipment automatically moves to the initial position. If it is turned on with the
equipment turned off, keep away from the moving arm.
- In case of abnormal movement or noise occurrence while the equipment is operating, press the emergency
switch and contact the corresponding agency or the A/S team of the main office.
In case of using the emergency switch due to an unexpected situation, go through the following procedure.
② Push the arm with a hand in one direction to have the person to be examined step down.
③ Have the person to be examined step down from the equipment and change the state of the main switch
④ Press the emergency switch one more time to have it returned to the original state.
⑤ Take a necessary action and turn on the main switch if there is no abnormality.
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3. Stopping the Operation of the Equipment When Natural Disasters like Earthquakes and
Fires Occur
① Press the emergency switch and push the arm in one direction to evacuate the examined person.
② Set the main switch in the off state and evacuate quickly.
For the safe use of the equipment, the accessory provided by B.M.Tech Worldwide. or the measurement
accessory approved by B.M.Tech Worldwide should be used. A user is fully responsible for the safety
accident of a user or a person to be examined and the error or mistake of the measurement value occurring
due to the use of the accessory not approved.
Do not put the spray type cleaning solution in the spray container for spraying on the
equipment.
CAUTION Spraying the spray type cleaning solution on the equipment may damage the electronic
device inside the equipment.
Be careful not to have the cleaning solution flow into the inside of the equipment.
- Clean the equipment cover by using the soft cloth coated with the cleaning agent diluted with water or
with the weak neutral detergent.
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- As for the cleaning of the monitor, take the dust out with the smooth brush or use the weak neutral
detergent if it needs to be wiped out. Wipe it out with the soft cloth coated with the detergent.
- It is recommended to wipe the monitor screen surface with the soft cloth or to use the monitor screen
detergent.
8. Maintenance
(1) Check whether there happened an abnormality to equipment after completion of measurement.
(2) Return to the state before use according to the designated sequence, and then turn OFF the power.
(3) Do not apply excessive force such as holding and pulling a cord, etc.
(5) Be sure to clean equipment to avoid any trouble for the next use.
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(7) When a trouble or abnormality is found, stop its use immediately and then contact an expert.
(8) Do not allow other persons than an expert to disassemble, repair or renovate this equipment.
(10) Even when not using the equipment for a long time, operate the equipment once a month to check
whether its operation status is good.
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4. Product Explanation
1. Overview
B.M.Tech Worldwide OSTEOPro is the osteoporosis diagnosis machine using an X-Ray. The value of the
bone density of a person to be examined is obtained by comparing and analyzing the data collected through
the analysis of the image acquired by scanning the spine, the femoral (Femur) and the forearm region in the
pencil beam manner with the X-ray having two mutually different kinds of energy.
2. Performance
Classification Description
Reproducibility <1% CV
A user can add or delete the bone and tissue possibly reducing the error
Correction of Special Parts
while calculating BMD such as fracture, implant, or operation part.
The result value, information on the examined person, and trend are
Multi-Output Function
outputted.
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①Laser Point Button Red “+” shape indicates the point in the scan area.
Bottom: X-Ray Generator, Located in the main frame and connected to x-ray control
X-Ray X-Ray Control Board board.
3
Machine Top: X-Ray Detector, Connected and located in upper arm connected to x-ray
Laser Pointer generator inside the main frame.
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(2) Rear
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3.4 Dimension
② Weight : 120 kg
- QC Phantom
- Power cable
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5. Product Specification
Div. Item Details Remark
Model OSTEOPro
Manufacturer Spellman
Model XRB80N100
Manufacturer Spellman
Manufacturer eV Products
Model eV-380
Detector
Color capture device Cd∙Zn∙Te
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6. Installation Method
(1) The equipment complies with "The Rules on the Safety Control of the Device Generating the X-Ray for
Diagnosis" of the Ministry of Health and Welfare Ordinance.
(2) The equipment specialist operated the equipment and protects the patient.
(3) The equipment is installed in the following proper place.
- The place should be safe from slope, vibration, impact, and so on and shouldn't be affected by air
pressure, temperature, humidity, ventilation, daylight, and so on.
(4) Check if the product is good and be well-informed of the operating manual of the product.
(5) Insert the "OSTEOPro" software CD into the computer and install the software according to the
directions.
(6) Connect the computer to the equipment with the RS232 cable and the power cable to the equipment.
(7) Have the person to be examined lie down comfortably on the patient support.
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Unpack the box packing and remove the carriage inside the equipment and the block fixing X-ray Tube Head.
③ Turn the fixed block clockwise to have four fixed blocks touch the ground for fixing.
④ Fold up both wings of the OSTEOPro bed to push into the equipment for fixing.
Caution! Installing or storing the equipment in the improper place may cause the performance degradation,
breakage, or abnormal operation.
- The place where the temperature is far higher or lower than the proper operating temperature of the
product
- The place where the equipment with the magnetic wave occurring is located
It should be connected after checking if the main switch is turned off when the AC power
CAUTION is authorized after installing or reinstalling the equipment. Otherwise, it may cause the
damage to the equipment.
The equipment must be installed on the flat floor without any slope. Otherwise, there is a
CAUTION possibility that it may move to the direction where the carriage or HFG with a lean is
located.
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OSTEOPro has four wheels in the lower part of the equipment and the fixed support. The method to use the
equipment is as follows.
④ Turn the fixed support counterclockwise to have the support away from the ground.
The carriage protection is needed to protect the equipment when tilting or lifting
CAUTION
OSTEOPro to move it. In that case, contact the A/S team or agency of our company.
The unfixed carriage during the movement of the equipment may cause an injury so
CAUTION
that a special attention should be paid.
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7. Operating Instructions
1. Running Software
(1) Turn on the master switch of the equipment and turn on the power switch of the external equipment
such as computer to turn on the power.
(2) The connection of the equipment to the connection cables are checked by clicking the OSTEOPro DEXA
icon on the monitor. If the connection is not normal, the error window is popped up.
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With the message window showing “Home For wrong connection, the message "Device is not
Positioning”, the equipment will work to move found" appears.
to the origin. ☞Click ‘OK’ button ⇨ Click ‘Exit’ ⇨ End program ⇨
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2. Main Menu
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3. Calibration
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3.2 RE-Calibration
If each step fails, ‘FAIL’ message is displayed in
red.
Ask for calibration retry and proceed with it again
with ‘Yes’ button.
*Please contact our company in case of repeated
‘FAIL’ displays. (calibration test failure)
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4. Measurement
Patient consideration :
WARNING
Please keep in mind the following patient considerations before measuring patients.
Clothes limitation :
Get rid of all stuffs to attenuate X-ray from patients (ex: clothes with zipper, ring,
WARNING
buckle and button, etc). Ask patients to wear sports suits and provide them with
inspection gowns when they arrive.
Pregnancy :
Measurement at pregnancy can reveal women’s womb to small portion of radioactive
rays. If it does not influence clinical management, please postpone measurement till
the late stage of pregnancy. Decision on exposure of a fetus to radioactive rays should
WARNING
be done by a doctor in charge. A doctor in charge has to deliver warnings that 1) bone
substance of most pregnant patients does not change drastically during pregnancy 2)
mineralized bone in the last stage of pregnancy can disturb measurement of vertebra
or femur.
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Patient chart no. (Selection of Direct input and Auto is possible – See below for
ID :
more information)
Name : Patient name
Date of Birth : Birth date, month and year
Gender : Check gender
Height : Write height in ㎝ (ft, inch) (Maximum 200cm)
Weight : Write weight in ㎏ (Ib) (Maximum 200kg)
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Menopause
Just for women.
Age :
Ethnicity : Selection of ethnicity such as Asian, European is possible.
ID
Height
Click CONFIGURATION from the Main Screen.
From the CONFIGURATION, the operator can
choose the unit of the height from cm, ft, inch.
The maximum recognizable height is 200 cm.
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Weight
Ethnic
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[Consecutive scanning]
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[Description of icons]
4. Start measurement
When site selection and positioning setting are finished, press ‘Complete’
button to start measurement.
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4.4 Measurement
On the measurement page, patient information, measurement time, remaining time, time elapsed are
displayed and X-ray condition is to be checked.
Scanning image
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4.4.1 Spine
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5) Measurement
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4.4.2 Femur
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Move both feet of the patient and fix them in line with
inclinations of both sides of the triangular bed.
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5) Measurement
Pressing ‘OK’ button or ‘SAVE’ button on
Positioning displays a selected measurement
part(square in red)
Measurement starts when pressing ‘Complete’
button.(square in green)
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4.4.3 Forearm
1) Select Forearm-L
From "SITE", select Forearm-L or Forearm-R
(Forearm-L selected). (L: Left, R: Right)
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Have the patient seat on the chair and place the left
hand on the "+" point.
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3) Measurement
*Measuring image.
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4.5 RESCAN
When the measuring point is not correct or is off the center, use the rescan function, which eliminates the
need to do over a measurement from the beginning.
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Measurement is completed.
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4.6 Analysis
When loading given measured data or when measurement is completed, press ‘Analysis’ to analyze
measurement values on the measurement part.
Load measured data using Spine, Femur-L, Femur-R, Forearm-L, Forearm-R buttons. (Last measurement
image is first loaded.)
[Measurement image]
[Description of icons]
Bone, Tissue, Draw, FILL, UNDO Edit bone_ and tissue areas on measurement image
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BONE Outline displayed in measurement image. If Outline is out of the image of the measured bone,
it is used. When pressing BONE button, Draw, FILL and UNDO buttons are activated.
TISSUE If Out Line is set in other parts than a bone(s) in a measured image, it is used to delete TISSUE
area. Pressing TISSUE button activates Draw, FILL, UNDO buttons.
FILL Fill lines drew with Draw and already selected areas with colors.
UNDO Return to former status when using Draw and FILL functions.
Edit (designate, exclude, correct) and analyze analyzed areas in measured image.
Spine : analyzer L1, L2, L3, L4 areas
Adjustment of size, inclination for each area(bent bones) is possible.
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1. Spine
Measured image is loaded.
Or load measurement image on which analysis is
needed.
NOTE If the measurement image is not accurate, do not edit and proceed with next step.
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[Spine]
When measurement image is loaded, click ‘ROI’
button and start measurement.
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2. Femur
Measured image is loaded.
Or load analysis-needed measurement image.
NOTE If the measurement image is not accurate, do not edit and go to the next step.
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3. FOREARM
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4.7 PRINT
Click gray bar(s) below measurement icons on the
analysis result screen. The color changes into pink
from gray
If the color of gray bar(s) does not change into pink from gray, SEND (DICOM) and print
CAUTION
are not possible.
[Multi-selection]
If selecting Spine and Femur-L, it is possible to
print measurement result from two parts with a
printer..
Print is possible about measurement result of up
to two parts
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4.8 Report
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[Multi Selection]
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4.9 SEND
If the color of gray bar(s) below selected button does not change into pink from gray,
CAUTION
SEND(DICOM) is not possible
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5. DATABASE
(Pressing “All” button would cause all the patient data to be displayed.)
Measure : Move patient information to measurement step.
History : Move the measurement data(information) of a patient to a window.
Backup : Backup database information.
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5.1 HISTORY
[Icons]
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6. CONFIGURATION
Click Configuration button in main mode.
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Communication Port
Automatic Port connection is performed upon the
connection between OsteoPro DEXA and
computer. Press the button enclosed in red
rectangle on the picture at the left for manual Port
setting.
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Height
Click CONFIGURATION from the Main Screen.
From the CONFIGURATION, the operator can
choose the unit of the height from cm, ft, inch.
The maximum recognizable height is 200 cm.
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Weight
Click CONFIGURATIO from the Main Screen.
From the CONFIGURATION,, the operator can
choose the unit of the weight from Kg, or lb.
The maximum recognizable height is 200 cm.
Backup Folder
By clicking the button enclosed in the red
rectangle as shown in the picture at the left, the
operator can view folder containing backed-up
files.
Backup Folder
Previously saved data is contained on the Backup-
folder,
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Report Type
The operator can choose from the Default or
Simple form of report.
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[Search]
It searches COMPORT between a computer and
an equipment.
Click “OK” button. For wrong connection, the message "Device is not
found" appears.
☞ Click ‘OK’ button→ Click ‘Exit’ → End
program
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7. EXIT
Click ‘Yes’.
When the program ends, Power Off for OSTEOPro
DEXA desktop.
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