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Document No BMT - UMD -X-101

OSTEOPro
Revision Date 2012. 02. 02.

Revision No Ver3.0
OSTEOPro DEXA
Page 1 / 94

OSTEOPro
MODEL: DEXA (Dual Energy X-ray Absorptiometry)

User Manual Ver 3.0

B.M.Tech. Worldwide Co.,Ltd. | OSTEOPro 1


Document No BMT - UMD -X-101
OSTEOPro
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- Contents -

1. Warranty 3

2. Safety Observances 4

3. How To Use It Safely 13

4. Product Explanation 17

5. Product Specification 21

6. Installation Method 23

7. Operating Instructions 26

B.M.Tech. Worldwide Co.,Ltd. | OSTEOPro 2


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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.

2. Requirements for a repair request

(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.

The return or replacement due to a surface defect is not allowed.


We are not responsible for the incidental and indirect damages related to the use of

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.

B.M.Tech. Worldwide Co.,Ltd. | OSTEOPro 3


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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.

NOTE provides the information on the installation, operation or maintenance being


NOTE
important to a user but being irrelevant to dangers.

Thanks for purchasing our product.


Be sure to read the operating manual before installation and use and to be experienced in the important
items for achieving the increased safety and the optimal performance.

B.M.Tech. Worldwide Co.,Ltd. | OSTEOPro 4


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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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5. Caution for Use


(1) Only the medical doctor or person qualified to use the equipment must operate the equipment.

(2) Be careful of the following matters when installing the equipment.


- Install it in the un-wet place.
- Install it in the place where there is no possibility of the bad effect caused by the air including the air
pressure, temperature, humidity, ventilation, daylight, dust, salt, sulfur, and so on.
- 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.
- Be careful of the power frequency, voltage, and permitted current value (or power consumption).

(3) Be careful of the following matters before using the equipment.


Check the connector's contact, polarity; dial setup, and meters and the precise operation of the equipment.
Check if all cord connections are correct and safe. The combined uses of the equipment block the correct
judgment or cause a danger so that it requires full attention. Recheck the contact surface directly contacting
a patient.

(4) Be careful of the following matters while using the equipment.


Carefully monitor if there is any abnormality in the overall equipment and a patient.
If an abnormality is found in the equipment or a patient, take a proper measure by stopping the operation of
the equipment when the patient is in the safe state. Be careful that a patient shouldn't touch the equipment
as the patient pleases.

(5) Be careful of the following matters after using the equipment.


Turn off the power after the operation switch and the dial are returned to the state before use according to
the prescribed sequence. When unplugging a cord, do not use the excessive force by pulling the cord. As for
the storage place, be careful of the following matters.
- Store it in the un-wet place.
- Install it in the place where there is no possibility of the bad effect caused by the air including the air
pressure, temperature, humidity, ventilation, daylight, dust, salt, sulfur, and so on.

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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.

(7) Do not remodel the equipment as one pleases.

(8) Repair check


Be sure to regularly check the equipment and parts. In case of reusing the equipment having not been used
for a while, be sure to check before use whether the equipment operates normally and safely.

(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.

(13) The target to be measured shouldn't include any metal material.

(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.

(22) The physical impact is not applied to the equipment.

(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.

Caution: Find the annex.


!

Protective Earth (Ground)

Earth (Ground)

Dangerous Voltage

ON : On (Power: Connected to Power Supply)

OFF : Power: Connected to Power Supply)

Shooting

X-Ray Being Radiated

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7. Label

7.1 Label 1 : Laser radiation label

“CAUTION”
If you look at the laser aperture directly without any protective device when using laser, your eyes may be
seriously damaged.

7.2 Label 2 : Warning Label on Product Mobility

“WARNING”.
If your finger or other body parts are put between the moving x-ray machine and the patient table, an
accident may occur.

7.3 Label 3 : Caution Label on Product Operational Temperature Range “CAUTION”

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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7.4 Label 4 : Product Name Plate Label

7.5 Label 5 : X-Ray Tube Head Label

B.M.Tech. Worldwide Co.,Ltd. | OSTEOPro 12


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3. How to Use It Safely

1. Operating the Equipment

- 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.

- A user should understand how to use the equipment.

- 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.

2. Use of the Emergency Switch

In case of using the emergency switch due to an unexpected situation, go through the following procedure.

① Press the emergency switch in case of emergency or abnormal movement.

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

of the equipment to the off state.

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.

⑥ Check if the equipment operates normally.

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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.

4. Safety Matters on Measurement Accessories

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.

5. Cleaning the Equipment

Be sure to turn off the main switch before cleaning.


WARNING
Separate the AC power cable from the power socket.

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.

- The part contacting a patient should be maintained to be always clean.

- Clean the equipment cover by using the soft cloth coated with the cleaning agent diluted with water or
with the weak neutral detergent.

- Do not spray the water or detergent on the equipment itself.

- Do not use the solvent or paint remover.

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6. Cleaning the Monitor and the Keyboard

Do not use the acid or alkali detergent to clean the monitor.


CAUTION
It may damage the monitor surface.

- 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.

7. Storage after Use

- Remove the power of the equipment after use.


- Clean and disinfect the equipment with the smooth cloth while power is being turned off.
- Do not use the wet cloth or solvent such as alcohol or acetone for wiping the equipment.
- The detergent including the abrasive may damage the surface of a component.
- It is stored in the place where it is not humid in the normal temperature and is well-ventilated.

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.

(4) Clean and arrange the components, cords, etc.

(5) Be sure to clean equipment to avoid any trouble for the next use.

(6) Proper control condition


① Temperature: 0℃ ~ 50℃

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② Humidity: 20% ~ 80%, Non-condensing

(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.

(9) Do not apply physical shocks to the 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

Scan Method Pencil beam

AP spine (Normal : 2' 22"),


Femur (Normal: 1' 58")
Measurement Part
Forearm (Normal : 1' 35")
(Measurement Time)
Non-stop Scan (AP Spine, Femur 4' 30")
Non-stop Scan (AP Spine, Dual Femur 6' 28")

Single Scan(AP Spine, Femur(R/L), Forearm(R/L))


Measurement Method Non-stop Scan (AP Spine, Dual Femur)
Possible to measure three parts at a time

Reference Data Standardized Data of WHO

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.

Automatically distinguishing the ROI (interest area) after the measurement


Auto ROI
is ended

Radiation Exposure Quantity No more than 10mRem at a time

System Linkage DICOM support

The result value, information on the examined person, and trend are
Multi-Output Function
outputted.

Trend Comparison Comparison of the trend data for each part

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4.3 Explanation on the Exterior

No. Name Description

Stop emitting X-ray during movement of x-ray machine


1 Emergency Stop Button
or if emergency situation occurs.

①Laser Point Button Red “+” shape indicates the point in the scan area.

Move X-ray machine in horizontal or vertical direction and


②Direction Button
check the position of patient with the center button.
Control
2 ③Check Button Set the current position as the reference position.
Panel
④Power Lamp Indicate that power is approved to the device

⑤Laser Point Lamp Indicate that laser point is in operation.

⑥X-Ray Generator Lamp Indicate that x-ray generator is in operation.

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.

Patient The patient support consists of the main support in the


4 ⑦Main support
Stand middle and assistant supports on the top and bottom of

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the main support.


⑧assistant support(Top) Examinee may lie down during measurement. It contains
x-ray generator of x-ray machine, x-axis movement
motor, y-axis movement motor, and electronic box.
Stand size at the head and foot part of the examinee can
⑨assistant be adjusted.
support(Bottom) The top and bottom assistant supports may be manually
pulled down by users vertically (*check the picture to see
the appearance)

(2) Rear

No. Name Description

① RS232 Port Connect RS232 cable to connect computer and product.

② Supply Plug Connect the power cable to supply power.

③ Master Switch Approve or remove power to and from the product.

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3.4 Dimension

(1) Main Frame

① Main Frame : 2000 (W) × 810 (D) × 1220 (H) mm

② Weight : 120 kg

4.4 OSTEOPro System Configurations

- OSTEOPro system unit (Excluded Computer System)

- OSTEOPro Software installation CD

- Measurement assistance (2EA for Spain and Femur)

- QC Phantom

- Operating (User) manual & Service manual

- Power cable

- LAN cable for communication

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5. Product Specification
Div. Item Details Remark

Manufacturer B.M.Tech Worldwide Co., Ltd.

Model OSTEOPro

Class and Type Class 1 type B equipment

Product Size 2000(W) × 810(D) × 1220(H)


Product
Weight 120 ㎏

Input Voltage and Frequency AC230V, 50 ㎐/60 ㎐

Power Consumption 500VA

Effective Period Semi-permanent

Manufacturer Spellman

Model XRB80N100

Maximum Tube Voltage 80 ㎸


X-Ray
Maximum Tube Current 1.25 ㎃
Generator
Input Voltage and Frequency AC230V, 50 ㎐/60 ㎐

Total Filltration 2.35 ㎜ Al

Manufacturer Spellman

Manufacturer eV Products

Model eV-380
Detector
Color capture device Cd∙Zn∙Te

Imaging Area 11 ㎜ In Diameter

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Image Size (Spine) 213 ㎜ x 108 ㎜

Image Size (Femur) 143 ㎜ x 128 ㎜

Image Size (Forearm) 128 ㎜ x 105 ㎜

Performanc Reproducibility <1% CV


e
X-Ray Radiation Period 1' 35" ~ 2' 22" (single mode condition)

No more than 10mRem for each inspection


Radiation Exposure Quantity
(5m distance)

Remnant Radiation No more than 1mRem (5m distance)

Operating Temperature 20℃ ~ 40℃

Appropriate Humidity 20% ~ 80%

Appropriate Pressure 700 ~ 1060


Environmen
t for Use Shock 2G in 6 × 10-3 sec or below

Storing Temperature -5℃ ~ 50℃

Storing Humidity 0%~90%

Others Apparent Resistance 0.18Ω

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6. Installation Method

1. Preparation before Use

(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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2. Installing the Equipment

The equipment installation method is as follows.

Unpack the box packing and remove the carriage inside the equipment and the block fixing X-ray Tube Head.

② Move the equipment to the installation place.

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.

⑤ Connect it to the AC power and the RS-232C cable to the PC.

⑥ Turn on the main power.

Caution! Installing or storing the equipment in the improper place may cause the performance degradation,
breakage, or abnormal operation.

The improper examples of equipment installation or storage

- The place with the excessively high humidity

- The place exposed to the direct light

- The place where the temperature is far higher or lower than the proper operating temperature of the
product

- The place where the product may be affected by impact or vibration

- The place with the high slope

- The place where chemicals are stored

- 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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3. Moving the Equipment

OSTEOPro has four wheels in the lower part of the equipment and the fixed support. The method to use the
equipment is as follows.

① Turn off the main power.

② Separate the AC power cable from the PC connection cable.

③ Pull down both wings of the OSTEOPro bed.

④ Turn the fixed support counterclockwise to have the support away from the ground.

⑥ Push and move the equipment by using the wheels.

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.

[If the connection is normal, the main screen is popped up]

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[The computer is connected to the equipment]

If connected If not connected

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 ⇨

Equipment Off /On ⇨ Restart program

☞If the same phenomenon occurs, click on the

"Communication Port" Search in “7.6. Configuration”,


to select Port and proceed to save.

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The main screen is popped up.

2. Main Menu

Measurement, Database, Calibration, Configuration, Exit

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3. Calibration

<Daily Process for QA Guarantee>


1. Take a QT test before measuring a patient every morning.
2. This procedure calibrates and verifies functions like accuracy, preciseness of a
NOTE density meter.
3. Please take a QA process at least once a day-except for scanning time.
4. If QA process is not taken before initial measurement, it does not go to measuring
mode.

3.1 Calibration Process

Click on Calibration Button on Main Mode of a


screen.

Click on ‘Yes’ button and proceed with calibration.

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Move to the position of initial measurement


mode of a scanner arm.
(Other works are not allowed while home
positioning.)

Place a phantom in the position of a ‘+’ form laser.


Position the phantom in line with Arm(in length)
and unite the ’+’ form line on the phantom and
the ‘+’ form of a laser)
Push OK button and proceed with calibration.

X-Ray Tube-Heating lasts for 120 seconds.

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Upon completion of tube heating, the followings


are checked one by one.
1) Phantom BMD check
2) Air Check
3) Alignment Check
For normal proceeding, PASS is displayed for each
step.

For normal calibration process, the message


‘Calibration is Completed’ is displayed
Push OK button.
Click to Home button on the top right and move to
Main Menu mode.

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.

Restrictions on radionuclide or radiopaque :


Please check whether a patient was restricted over radionuclide or radiopaque for the
last 3-5 days. If patients got an inspection related to those restrictions, please postpone
WARNING
measurement until all the traces of those elements disappear in patients’ bodies.
Usually, all those elements disappear in patients’ bodies within 72 hours. However,
consult with RSO (radiation safety officer) in advance.

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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4.1 Running Measurement


To start measurement, Push ‘Measurement’
button.

4.2 Input Patient information


Input the information of a patient in stand-by for
measurement. And push “Measure”
(For given patients, or if measurement was done
before, after searching (9) Database on page 57
and double click, which leads to patient
information mode.

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

Click CONFIGURATION from the Main Screen.


From the CONFIGURATION, selection of Auto
mode from PATIENT ID GENERATION would
enable automatic encoding of ID in following
order: Year – Month – Date – Time. Selection of
Manual mode would enable operator to manually
input patient 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

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.

Ethnic

Click CONFIGURATIO from the Main Screen.


From the CONFIGURATION. The operator can
choose the ethnicity of a patient, such as Asian,
European, etc..

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4.3 Select measurement part


Select measurement part in SITE.
Femur-R, Femur-L, Spine, Forearm-R, Forearm-L
(L: Left, R: Right)
You can select measurement parts up to three.

*Refer to [consecutive scanning]

When selecting a measurement part, the message


"Set reference point of spine (Femur)" appears.
If selected measurement part is right, push “Yes”
button, which will make X-ray equipment move to
measurement position.
If measurement part is wrongly selected, press
“No” and reselect measurement part

With a X-ray equipment moving, a laser pointer is


activated
Regulate precisely to exact measurement part
using a positioning button(control panel of the top
on X-ray equipment)
After fine regulation, when precisely adjusted for
selected measurement part, press ‘SAVE’
button( ■ square button).

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Press ‘Complete’ button, which links to


Measurement page.
[Selection order]
For measurement, go to Site selection ⇨
Positioning selection ⇨ Complete.

[Consecutive scanning]

Select ‘Measurement position’ button inside the


SITE.
Regulate position using positioning buttons
↑↓←→ (regulation possible on the arm control
panel of X-ray equipment).
When position is set with positioning buttons,
press ‘SAVE’ button( ■ square button). (Repeat
the processes above to save measurement
positions for three parts).

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[Description of icons]

1. Select measurement part


Select measurement part in SITE.

2. Fine regulation of measuring position.


Regulate position using positioning buttons ↑↓←→ (regulation
possible on the arm control panel of X-ray equipment).

3. Save measurement position

When a position is set, save it using ‘SAVE’ button( ■ square button).

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.

Please make sure that patients do not move till


measurement completion. When measurement is
completed, press ‘Analyze’ button which links to
analysis mode. (When a certain time passes by, it
automatically turns into Analysis mode).

Scanning image

If measurement position is not accurate or images


are inappropriate because of patients’ moving or
abnormal conditions, press “Stop”. The equipment
stops and a message appear.
Upon pressing ‘Yes’ button, equipment stops.

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For re- scanning, press “Rescan". A re scan request


message window appears. By pressing ‘Yes’,
rescanning process starts.
If positioning is needed, press “No” and restart
from the patient information inputting step.

Afterwards, a green rectangle shows up in the


control box. Drug the rectangle to the part of the
control box to where you would like to change the
position of the scanned image to. Then press
“Scan” to begin the rescanning process.

Refer to section 4.5. Rescan for more information.

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4.4.1 Spine

(1) How to measure spine

1) Select spine measurement


“Select ‘Spine’ for “SITE” part.

When measurement part is selected, the message


“"Set reference point of Spine" appears.
If selected part is right, press “Yes” which makes a
X-ray equipment to move to a set measurement
position.
If selected part is wrong, press “No” and reset
measurement part.

With X-ray equipment moving, a laser pointer is


activated.

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2) Measurement position for spine patient.

When the patient lies down in on the main support,


situate patient’s head as shown in the picture at the left.

When measurement is ready, X-ray equipment goes to


initial position and stops.

When ‘Spine’ is selected, X-ray equipment moves to the


position set in advance.
(A laser pointer appears.)

Position a patient so that he or she is not out of the bed.


Pay attention that patients do not crash to X-ray
equipment or catch it with a hand.
(The measurer should help nearby.)

Please pay attention so that patients’ hands do not


enter the conveying unit of a X-ray equipment (arrow-
marked part)

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3) Select a supplementary bed


A square-type supplementary bed is needed for spine
measurement.

4) Measurement fiducial point for spine measurement

While seeing a laser pointer, regulate measurement


position to measurement fiducial point of a patient
using direction moving buttons on the control panel of a
X-ray equipment and do fine adjustment for
measurement position.
If it is far off the measurement fiducial point and a laser
pointer, move the patient to be positioned at
measurement fiducial point part

*Measurement fiducial point for spine patients*


Around 3-4cm(usually) below from the belly button.

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Please do fine adjustment using direction fine-


adjustment buttons on the control panel of a X-ray
equipment.
If you use fine adjustment buttons on PC, same fine
adjustment is possible.
When fine adjustment is done, press ‘OK’ button or
‘SAVE’ button on PC.

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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)

It ‘s an image during measurement

When measurement is completed, the X-ray


equipment goes to initial position and stops
When pressing ‘Analysis’ button, it goes to
analysis mode.
*Refer to ‘Analysis’ page for measurement
method.

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4.4.2 Femur

(1) Measurement method for Femur-L

1) Select Femur-L measurement

Select Femur-L or Femur-R on ‘SITE’.(Select


Femur-L)
(L: Left, R: Right)

When measurement part is selected, the message


‘Set reference point of Femur’ appears.
If selected part is right, press ‘Yes’ which will make
X-ray equipment move toward set measurement
position.
If selected part is wrong, press ‘NO’ and reselect
measurement part.

With X-ray equipment moving, a laser pointer is


activated.

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2) Measurement position for Femur-L patient

When the patient lies down in on the main support,


situate patient’s head as shown in the picture at the left.

When measurement is ready, X-ray equipment goes to


initial position and stops.

When Femur-L is selected, X-ray equipment goes to the


position set in advance.
(A laser pointer appears.)

Position a patient so that he or she is not out of the bed.


Pay attention that patients do not crash to a X-ray
equipment or catch it with a hand.
(The measurer should help nearby.)

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Please pay attention so that patients’ hands do not


enter the conveying unit of a X-ray equipment (arrow-
marked part)

3) Select a supplementary bed


A triangular-type supplementary bed is needed for
femur measurement.

4) Measurement fiducial point for Femur-L patient


Fix both feet of a patient to a triangular type
supplementary bed.
Move the patient so that the laser pointer can be
positioned toward his or her Femur-L measurement
fiducial point.

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Move both feet of the patient and fix them in line with
inclinations of both sides of the triangular bed.

Do fine adjustment using direction adjustment buttons


on the control panel of a X-ray equipment so that the
laser pointer moves toward Femur-L measurement
fiducial point.
* Measurement fiducial point for Femur-L patient
Thigh bone part around 20cm away from femur
bone(protruded bone on the waist)

Please do fine adjustment using direction fine-


adjustment buttons on the control panel of a X-ray
equipment.
If you use fine adjustment buttons on PC, same fine
adjustment is possible.
When fine adjustment is done, press ‘OK’ button or
‘SAVE’ button on PC.

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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)

It ‘s an image during measurement.

When measurement is completed, the X-ray


equipment goes to initial position and stops
When pressing ‘Analysis’ button, it goes to
analysis mode.
*Refer to ‘Analysis’ page for measurement
method.

(2) Measurement method for Femur-R

⇨ Same as measurement method for Femur-L


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4.4.3 Forearm

(1) Measurement method for Forearm-L

1) Select Forearm-L
From "SITE", select Forearm-L or Forearm-R
(Forearm-L selected). (L: Left, R: Right)

When a selection is made, the message "Set


reference point of left forearm" appears.
If the selected measuring point is correct, press
"Yes" to move the x-ray device to the selected
point.

If the selected measuring point is wrong, press


"No" to reset the measuring point.

As the x-ray moves, the laser pointer is activated.

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2) Measurement position for Forarm-L patient

Situate a patient’s arm as shown in the picture at the left


– Allow the patient to point the tip of his middle finger
towards the red circle in the picture.
When measurement is ready, the x-ray device returns to
its original position.

Have the patient seat on the chair and place the left
hand on the "+" point.

Place the left hand in parallel to the bed.The laser "+"


point should be on the wrist.

As the laser "+" point is on the wrist, start a


measurement.

(While the scanner arm is operating, be careful not to


hurt the head.)

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When detailed adjustment is completed, press the "OK"


or "Save" button on the PC.

3) Measurement

When you press the "OK" button or Save button


from Positioning, the selected measurement point
appears.

Press the "Complete" button to start a


measurement (Green square).

The measurement starts.

*Measuring image.

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When measurement is completed, the x-ray


device moves back to its original position.

Press the "Analysis" button to go to the analysis


screen.

* For analysis methods, see the "analysis" page.

(2) Measurement method for Forearm-R

⇨ Same as measurement method for Forearm-L


- Allow the patient to point the tip of his middle finger opposite the red circle as show in the picture above
then position the laser on his wrist.

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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.

For all sites, you can use rescan.

On the Measure screen, the measuring Outline


appears.

If the location is wrong, press the "Stop" button.

The message "Do you want to stop Measurement?


“Appears.

1) Press Yes to enable RESCAN.


2) Press No to enable ANALYSIS. As the HOME
button becomes available, you can go to the
analysis or initial screen after the measurement is
completed.

This is the screen when the "Yes" button is pressed


and RESCAN is activated.

Click the RESCAN button.

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Just as in the left figure, the control box appears.

Move the measuring image to the center of the


control box.

When the measuring image is at the center of the


control box, press the "Start" button.

As soon as the Start button is pressed,


measurement starts again.

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The measuring point is at the center and


measurement is progressing.

Measurement is completed.

Click the Analysis button to go to the analysis


screen.

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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]

Spine Select for spine measurement

Femur Select for femur measurement

Forearm Select for forearm measurement

ROI Designate and analyze measurement area

Bone, Tissue, Draw, FILL, UNDO Edit bone_ and tissue areas on measurement image

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Print Print saved analysis result into a ‘report’

SEND Send saved analysis result via ‘DICOM’

[Description of function buttons]

Use it in the following order: “BONE ⇨ Draw ⇨ FILL ⇨ BONE”

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.

Use it in the following order: “TISSUE ⇨ Draw ⇨ FILL ⇨ TISSUE”

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.

Draw To draw the Outline of a bone..

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.

ROI Femur : analyze Neck, Ward, G.T. areas.


Adjustment of width, inclination on Neck area is possible
(Ward, G.T. are automatically selected with selection of Neck areas)
Forearm : analyze Ulna UD, Ulna 33%, Radius UD, Radius33% areas.

Save analysis result


Press each ‘gray bar’ below Spine, Femur(L/R), Forearm(L/R) selection buttons and save
Others
analysis result.
* Without saving analysis result, printing and DICOM transmission are impossible.

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[Measurement method details]

1. Spine
Measured image is loaded.
Or load measurement image on which analysis is
needed.

1.1 Edit measurement images

NOTE If the measurement image is not accurate, do not edit and proceed with next step.

As the figure above, it is possible to edit excluding


the marked part in red.

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When clicking “BONE”, it goes to Outline edit


mode in bone image and Outline edit is possible.

Click “Draw” and draw Outline in line with bone


image using a mouse

Click “FILL” and fill interior of Drew part after


clicking it with a mouse.

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When re-clicking ‘BONE’, one can identify edited


Outline of a bone image.

NOTE On the contrary, editing Tissue area is possible.

1.2 Analysis of measurement image

[Spine]
When measurement image is loaded, click ‘ROI’
button and start measurement.

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When bringing a mouse to the measurement


image, “─” line appears.

Click the starting point (End point) of whole area.

Click endpoint (starting point) among the whole


area on which analysis is wanted.

When starting point and endpoint of analysis-


needed area are selected, analysis areas L1-L4 are
displayed as seen from the image on the left.

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If measurement needed area is wrongly selected,


change the area with clicking and moving ‘O’ part
upward/downward using a mouse, as the image on
the left. **See(Mouse drag image)
upward/downward mouse drag display
(round-type display in blue)
↕ move upward and downward with an axis of

each point of left _ and right side.(round-type


display in red, inclination change)

If adjusted analysis area is rightly selected, click


‘ROI’ and identify final analysis result.
As seen from the image on the left, a graph
appears in the right top. Given measurement
result is displayed on the center.(displayed in the
measurement order- latest measurement comes
first)
Detailed measurement result is to be identified on
the bottom.

If you want to exclude any part from the analysis


area, you can see analysis result as you want by
clicking the corresponding area. However, click
‘ROI’ and identify the final analysis result again.
On the right of the screen, analysis result comes
without the excluded part.

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2. Femur
Measured image is loaded.
Or load analysis-needed measurement image.

2.1 Editing measurement image

NOTE If the measurement image is not accurate, do not edit and go to the next step.

As the red square box above, it is possible to edit


Outline excluding the marked part in red.

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When clicking “BONE”, it goes to Outline edit


mode in bone image and Outline edit is possible.

Click “Draw” and draw Outline in line with bone


image using a mouse.

Click “FILL” and fill interior of Drew part after


clicking it with a mouse.

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When re-clicking ‘BONE’, one can identify edited


Outline of a bone image.

NOTE On the contrary, it is possible to edit Tissue areas.

2.2 Analyzing measurement image


When measurement image is loaded, click ‘ROI’
button and start measurement.

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If measurement is on the way, click Femur to call


measurement image.
When measurement image is loaded, click ‘ROI’
button and start measurement.

Click starting point of Neck analysis area.


(See the marked part with O in the image above)

Click end-point on Neck analysis area. (See the


marked part with ‘O’ in the image above)
* Inclination degree; to be vertical from Neck
center

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If analysis area is wrongly selected, adjust it using


parts marked with ‘O’.
“○” in blue; change position, adjust in clicked
mode.
“○” in red; change inclination, adjust in clicked
mode.

If adjusted analysis area is rightly selected, click


‘ROI’ and identify final analysis result.

If you want to exclude any part from the analysis


area, you can see analysis result as you want by
clicking the corresponding area. However, click
‘ROI’ and identify the final analysis result again.
On the right of the screen, analysis result comes
without the excluded part.

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If you want to exclude any part from the analysis


area, you can see analysis result as you want by
clicking the corresponding area. However, click
‘ROI’ and identify the final analysis result again.
On the right of the screen, analysis result comes
without the excluded part.

[Name of measurement areas]

3. FOREARM

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When the image is loaded, press the "ROI" button


to start analysis.

Click the red point with a left mouse.

Four (4) measuring areas appear.

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Click the area between Ulna 33% and Radius 33%


with a left mouse.

The red point can move left or right.

* This can be used when the bone is bent or the


area is off the center.

When the area is selected and there is nothing to


correct, press the "ROI" button to obtain
measuring results.

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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

CAUTION In SEND (DICOM transmission), take same method (as in printing).

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[Print conversion] Default version

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[Print conversion] Simple version

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4.8 Report

Patient information, hospital information and measurement content are displayed.


[Single Selection]

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[Multi Selection]

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[See] - Explanation of a graph


A graph shows measurement result visually. BMD(g/㎠) of a patient is displayed in diagram form
with aging. Black point means a patient. Each colored bar below the dark-green section represents
single standard deviation below for young adult. Thin line dividing dark-green and light-green
shows -1 T-score. T-score of the following patient can be decided.

T-score is standard deviation between BMD of patients and


that of young adult. Negative T-score means that BMD of a
patient is lower that of healthy youth reference group.
Positive score means that BMD of a patient is higher than
average reference values of young adults. T-score is an
industrial standard used to interpret DEXA result.

The black bar(s) display reference from same ages and


show bone density change with aging. The middle black
baris regression line.

A regression line shows expected BMD on a certain


measurement part in different ages. Blue bars display +/-
1standard deviation between BMD of a suggested patient
and that of a same age group.

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4.9 SEND

Use it in the hospital where PACS system is installed.


NOTE
It is impossible to use it where PACS system is not installed.

Click ‘gray bar(s)’ below measurement part


selection button on the measurement result
screen for Spine, Femur, and Forearm. The color
changes into pink from gray.
If you want to add, click the selection button for
corresponding measurement part and click ‘gray
bar’ below corresponding measurement part
button. The color changes into pink from gray.
Click “SEND” button.

If the color of gray bar(s) below selected button does not change into pink from gray,
CAUTION
SEND(DICOM) is not possible

Press ‘SET’ to select “PACS”.

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The window “PACS SETTING” appears. Input


selected values and SAVE them.

You can check right setting by pressing “Echo


Test”.

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If the message window for "ECHO SUCCES"


comes, setting is completed.
Click "Send" button.

A window with "Dicom Convert Finish" message


appears.

To complete Dicom transmission, click "Close"


button.

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5. DATABASE

Click ‘Database’ button in main mode.

“Database” window appears.

Delete : delete patient information


Modify : modify patient information
Search : search patient information
ID, Name, Gender, Birth. Date, Reg. Date, ALL(all the lists measured and saved)
☞ Select one of the Search options, input the data you would like to search for, then press “Search” button.

(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

Click a patient for analysis and click


“History” button. .

It is possible to see measurement content of a


patient and to check his or her cure condition and
development degree on each measurement.

If you want a certain measurement content, you


can search it quickly at the SITE by selecting
corresponding SITE. (If measurement content is
big)

[Icons]

Analyze : Go to analyze mode. See “4.6 analysis”.


Delete : Delete selected analysis information.

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6. CONFIGURATION
Click Configuration button in main mode.

Window to input the data is shown.

Input the corresponding data.

Communication Port : Automatically search and set ports of an equipment.


Patient ID Generation : Set ID generation automatically and manually.
Direct input for manual input, Auto input for Auto input (Year-Month-Date-Measurement time)
Doctor : Save Name, Phone No., Doctor information.
Hospital : Setting possible for hospital name, hospital address, hospital tel. no and hospital
logo.
Language : Select languages to shift screen languages.( It is possible to select from Asian,
European , etc.)

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Unit (Height) : Set height in ㎝(ft, inch) (Maximum 200cm)


Unit (Weight) : Set weight in ㎏(Ib) (Maximum 200kg)
Backup Folder : Set folders for back-up location.

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.

Set ID generation automatically and manually.


Direct input for manual input, Auto input for Auto
input (Year-Month-Date-Measurement time)

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Doctor and Hospital info.


Hospital information needs to be encoded in the
fields encircled in the red rectangle.

Select languages to shift screen languages.( It is


possible to select from Asian, European , etc.)

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.

[Input additional information]


Input additional information and click "Save".

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[Search]
It searches COMPORT between a computer and
an equipment.

[COMPORT SERCH RESULT]

If connected If not connected

Click “OK” button. For wrong connection, the message "Device is not
found" appears.
☞ Click ‘OK’ button→ Click ‘Exit’ → End

program → Equipment Off /On→ Restart

program

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7. EXIT

Click ‘Exit’ in main mode.

Click ‘Yes’.
When the program ends, Power Off for OSTEOPro
DEXA desktop.

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European Authorized Representative:


Representative L’can l’accesssorio nucleare S.R.L
20023 Cerro Maggiore-via
via XXV Aprile 9/13,
9/13 ITALY
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