Portable Dental X-ray System

BPD-1

User Manual

CE 1984 .
Document No.:BM-UM-01
Issued Date:29 AUG 2014
Revislon :1.5
The original version ofBPD-lbeingwritteninEnglish

'IIIIUJIDll llllll

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THE BEST MEDICAL ITEMS
 User's Manual

Contents

l11struction

'>nfety Marks

Warranty

Chapter I. Application

Composition

Chapter II. Specifications

Main Body

Battery

Charger

Cha pter Ill. Unit Description

Name of part

Functional Explanation

Chapter IV. Operation

Power ON

Power OFF

Set of exposure condition

Exposure

Battery Charging and Replacement

"" MODE " Function

Changing Set value at the '' MODE "

ChapterV. Error Code

Chapter VI. Unit Drawing

Chapter VII EMC Information BPD-1

Chapter VIII Life Time

BEMEMS Co., Ltd. BPD-1 (Rev. 1.5) 1

 User's Manua
User's Manual
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1. Introduction

Manufacturer and
I hank you , for purchasing the BPD-1 Hand held Portable Dental X-Ray Unit. This manual contains installation,
EU authorized representative
operation , and maintenance instructions; that should only be performed by a service technician experienced in

Manufacturer: these procedures.

• BEMEMS Co., Ltd.

1.1 Intended Use

• (Rm 709 710 711, Hoseodae Venture Tower Gasan-dong), 70, Gasan Digital 1-ro,
Geumcheon-gu, Seoul, Korea. The BPD-1 is an advanced high frequency field dental x-ray device rated at 60kV DC and 2 mA tube

current, with inverter X-ray control methods for producing diagnostic high quality tooth and maxillary bone
+ Telephone: +82-2-2627-5660
+ Facsimile: +82-2-2627-5665
images, for both chemical film and digital sensors. The BPD-1 operates on a 22.2VDC supplied by a

• Phone Extension Information:

rechargeable Li-Polymer battery pack. When x-rays are taken the device can either be handheld , or
+ Overseas Customer Service: +82-2-2627-5662
+ Overseas Sales Dept.: +82-2-2627-5662 mounted on a tripod .

1'- NOTE! This device is only intended for use by authorized or qualified personnel.
BEMEMS Co., Ltd. will make available on request circuit diagrams, component part lists, descriptions, calibration Caution*
Please, read the user's manual before use.
instructions, or other information which will assist the user's appropriately qualified technical personnel to repair
those parts of equipment which are designated by the manufacturer as repairable.

In order to protect the unit against damage, and ensure proper and safe

EC authorized representative:
* Reference * usage , please, make certain that all of the user 's manuals precautions are
• Obelis S.A
strictly adhered to.

• Bid. General Wahis 53 1030 Brussels, Belgium

+ Telephone: +(32) 2 732-59-54 Type B Applied Part provides the lowest degree of patient protection of all
+ Facsimile: +(32) 2 732-60-03 * Reference *
the types of applied part and is not suitable for direct cardiac application.

BEMEMS Co., Ltd.

BPD-1 (Rev. 1.5) 2 BEMEMS Co., Ltd. BPD-1 (Rev. 1.5) 3
 User's Manua User's Manual
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direct sunlight.
2. Safety Marks
e Do not store device near or around flammable material, or explosive gases.
Please, observe the following safety requirements:
e Do not keep the battery-pack long with charger connected.

e Do not keep the digital sensor with the main body connected. The digital sensor is very sensitive
&
WA"NING
e Do not exceed x-ray dosage necessary for image diagnosis. device so it has to be kept in the separate keeping case for it.

e intended only for use by qualified personnel. e vou can not do exposure the unit when you are connecting the charger and under charging.

e Do not allow the patient to touch the device.

e Do not leave device unattended around patients. 2) Caution

e lf device seems defective, please, contact your authorized dealer. • Do not expose device to the extreme shock or vibration.

e u is prohibited to tamper with the structure of the device e Do not place device in/on a dusty, dirty, or inclined place.

e Avoid usage in the following conditions: ePrior to use of the sensor, keep the sensor covered with disposable cover for it without fail.

- Around flammable material or explosive gas eDo not jerk the connection cable between the charging desk device and the charger

- Where it is damp or moist

- Direct Sunlight
3) Reference

- Poor ventilation areas echeck condition of the battery-pack and device before usage.

- Dusty areas euse the device according to the procedure for operation.

- Humid places
euse the device in a ventilated area.

- Salty places euse only the charger provided with this product.

Keep the device in the conditions listed below:
• For safe-keeping; temperature -40 C-70C, humidity 10%-90%RH
• During usage; temperature -10 ·c -40 'C, humidity 30%-70%RH
eEnsure the battery charger is unplugged before attempting to clean. Keep the unit clean by using
clean dry piece of cloth. Only use non-alcohol based disinfectant wipes, or dampened with liquid or
spray.

• For optimum conditions; temperature 10 C -30 C, humidity 40%-60%RH 4) Guarantee

eThis product is warranted for one year for its quality from the date of purchase.

1) Storage e1n case it is hard to recognize the warranty period, the warranty is applicable three months after it was

e Do not store the device where it is damp, salty, or in dusty locations. These conditions may cause manufactured.

operating problems. eFor the case of defects of the products itself or improper workmanship, the product will be either

e Do not store device in places where the temperature fluctuates drastically. Do not place the device in repaired free of charge or exchanged according to the status of the product.
BEMEMS Co., Ltd. BPD-I (Rev. 1.5) 5
BPD-l (Rev. 1.5) 4 BEMEMS Co., Ltd.
 User's Manua Use(s B
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eEven within the warranty period, if the damage is caused by failure of the user, the repair free of
<loses and follow all guidelines dictated by your in-house radiation protection program in regard to patients and
charge is not applicable.
operators who are pregnant or expect to become pregnant. In implementing a radiation protection program,
e1n case attached level for sealing is removed or has such an indication, repair free of charge and
warranty are not applicable. please consult any state, provincial, and local regulations governing radiation protection and the use of x-ray

eThe repair done at the place other than designed A/S Center is excluded from warranty. nqu,pment. Ensure proper registration and compliance with any such regulation.
eThe service period will not be extended for the product which was repaired with charge or free of
charge.

Do not operate the BPD-1 until patient and operator are positioned and ready for exposure, diminishing the

2.1 Cleaning likelihood of interruption and preventing inadvertent exposure of anyone to x-rays. Do not attempt an exposure

Ensure the battery charger is unplugged before attempting to clean. Make sure the power on the BPD-1 is off ,1 anyone is positioned immediately behind the patient (in line with the direction of x-ray emission). An

while cleaning. Only use a non-alcohol based disinfectant wipe or cloth dampened with liquid or spray. oxposure can be prematurely terminated for any reason by abruptly releasing the trigger button.

The BPD-1 and its accompanied battery charger, are not designed to be subjected to any kind of sterilization

procedure.

BPD-1 has been tested and found to comply with the limits of electromagnetic compatibility standards for

medical device (IEC 60601-1-2:2007), which provides reasonable protection against harmful interference in a

typical medical/dental setting. BPD-1 may generate and radiate radio frequency energy that causes

interference to other devices in the vicinity, if not used in accordance with the instructions {though there is no

guarantee that interference will not occur in a particular instance).

If interference does occur the user is encouraged to try the following corrective measures: reorient or relocate

the receiving device; increase the separation between the equipment.

This x-ray unit may be dangerous to the operator and patient unless safe exposure factors and operating

instructions are observed.

Keep in mind that the optimal radiation to the operator exists within a cone-shaped area immediately behind

the backscatter shield {the so-called zone of significant occupancy). All personnel authorized to operate the

equipment should be fully acquainted with safety recommendations and established maximum permissible

BEMEMS Co., Ltd.

BPD-l (Rev. 1.5) 6 BEMEMS Co., Ltd. BPD-1 (Rev. 1.5) 7
 User's Manua User's Manual
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Zone of significant occupancy
,ind exclusively limited to the repair or replacement of the product or part. This warranty shall be void on any
Requiring presence of an operator, provide with at least one significant zone of
product on which the serial number has been altered, defaced or removed.
occupancy which has a fioor area of not less than 2· x 2·, and a height of not

less than 6.5'

4. Quality control procedure

It kV, mAs measured with a one-year period.

• The type of radio examinations the significant zone of occupancy is

Measuring the deviation is ±5%, the measurement points are as follows.
designated to be user.

•· Location of the significant zone of occupancy including the positions of its

boundaries relative to clearly recognizable features of the x-ray

equipment.

(', Identity of the removable protective devices for use with the x-ray

equipment and information on their application and use.

3. Warranty

Warranty: BEMEMS Co., ltd, warrants that all parts shall be free from defects in workmanship and materials,

under normal use and with appropriate maintenance, for one (1) year from the date of delivery to the customer ll is measured with an Oscilloscope

unless otherwise specified in writing. !iO kV 0.5 s (2 mA) Test Benchmark

kV Check Point (TP 6) = 6 V (Oscilloscope)= 60 kV

BEMEMS Co., ltd,, shall not be liable for any damage, injury, or loss arising out of the use of the product,
rnA Check Point (TP 9) = 4 V (Oscilloscope)= 2 mA

whether as a result of a defect in the product or otherwise, if, prior to such damage, injury or loss, the product

was (1) damaged or misused; (2) repaired, altered or modified by persons other than BEMEMS Co., ltd; (3)

not installed in strict compliance with applicable codes and ordinances; or (4) not installed by an authorized

dealer. BEMEMS Co., ltd, obligation for breach of this warranty or for negligence of otherwise, shall be strictly

BEMEMS Co., Ltd.

BPD-1 (Rev. 1.5) 8 BEMEMS Co, Ltd. BPD-1 (Rev. 1.5) 9
 Portable Dental Portable Dental X
User's Manual
User's Manual
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Chapter I. Application

Chapter II. Specifications

This unit is BPD-1, the portable dental wireless X-ray system with high frequency inverter control.

1. Composition. 1 Main body

1.1 Main body

1) X-ray generator
• X-ray generator
(1) Tube Voltage 60 kV (Fixed)
• X-ray exposure cone
(2) Tube current 2 mA (Fixed)
• High capacity battery

2) X-ray Control device

1.2 Accessories
(1) Main power Battery 22.2 V DC, Adaptor 25.6 V DC
• Battery charger : 1 ea
(2) Exposure time 0.01 - 2.00 sec (Manual 56 steps)
• Neck strap : 1 ea

• Hand strap :1 ea
"l) X-ray Exposure
• Users Manual:1 ea
(1) Type Round style

(2) Output Radiation Field 60 mm

(3) SSD(standard) 100 mm

(4) SSD(Optional) 200 mm

4) X-ray tube

(1) Type Stationary anode X-ray tube

(2) Tube Model 0-0818

(3) Tube Focus 0.8 mm

(4) Anode heat capacity 8.5 kHU

(5) Maximum Tube Voltage 65 kV

(6) Target Angle 20 •

(7) Total filtration Basic filtration 0.8 mm Al

BEMEMS Co., Ltd.
BPD-l (Rev. 1.5) 10 llEMEMS Co., Ltd. BPD-1 (Rev. 1.5) 11
 Portable Dental )(
Portable Dental X
User's Manua
~ User's Manual

Additional filtration 1.0 mm Al

Chapter Ill. Unit description
(8) Cooling system Oil Cooling
Part name of unit

1) Front view
2. Battery

1) Type Li-ion Polymer

2) Voltage 22.2 V DC
G) G)
3) Capacity 950 mAh

....... l"J. I •, • "• '°' "' < t • ~ ,, > t ~ • •

3. Charger G)
1) Input 100 - 240 V AC, 50 -60 Hz

2) Output voltage 25.6 V DC

3) Output current 0.5 A

4) Status display of unit LED (Red: Under charging , Green: Finished charging)

(1 Status display(LED)

2 X-ray EXPOSURE button

3 X-ray Exposure cone

4 Hand strap ring

BEMEMS Co., ltd.

BPD-1 (Rev. 1.5) 12
Ill MEMS Co., Ltd. BPD-1 (Rev. 1.5) 13
 Portable Dent
Users Manua User's Manual
®1 ~-" r@
I) Side view
2) Rear view

ffi.~·- ·-~
04 \ c---.:-........
--1 : ~
@
© @

s Necklace strap ring

6 Adult mode button
7 Child mode button
a, Power ON button
9 Power OFF button
10 EXPOSURE time change(+) @ Battery replacement cover
11 EXPOSURE time change(-)
12 EXPOSURE time save
13 MODE button
14 Charging connector
qs Hand switch connector
@) Standard fixing Hall
@ LCD screen
@ Tooth types

BEMEMS Co., Ltd.

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 Portable Dental X
User" s Manual
~ User's Manual

2. Functional explanation.
I Child mode button
, 1 Status Display on the LED

+ If you press the button, it displays CHILD and symbol on the LCD.
• LED color changing: Unit status display
+ Off -> Turn off
+ Green -, Standby for shot
+ Yellow -> Exposing X-ray
+ Red -> Unit error
2 X-ray EXPOSURE button Power ON

+ It makes use of X-ray EXPOSURE.

+ It is a button for turn on the unit.
+ If you press the button 2 seconds more, it will exposure for the
set time.

• If you release the button before 2 seconds, it occurs an unit

error
3IX-ray Exposure cone
l'ower OFF

+ We made the inside of cone with lead. it prevents from exposing

the X-ray to the user. + It is a button for turn off the unit.

4 Hand strap ring

l :11.1nging exposure time up(+)

+ The top and bottom rings are connected with hand strap.

+ When presses the button, the exposure time will be increased.

s Necklace strap ring

+ It is for connecting with necklace strap.

( /,;1ng1ng exposure time down(-)

Adult mode button

+ When presses the button, the exposure time will be decreased.

•
+ If you press the button , it displays ADULT and symbol on the LCD .

1v111g exposure time

+ If you press the button 2 seconds more, the exposure time is stored.

BEMEMS Co., Ltd.

BPD-1 (Rev. 1.5) 16 Ml M S Co., Ltd. BPD-1 (Rev. 1.5) 17
 User's Manual
User's Manual

13 User's MODE button

~~~~~~~~ ~

•
c•hapter IV. Operation

• If user want to change the set item, press the button and you ca n
I I urn ON
enter the set item area.

14 Charging connector
I I When press the ON button and the unit turns on with beep sound.

• The connector is for the purpose of charging battery. I I I D blinks green while booting and it lights up green while standby.

15 Hand switch connector

) Wiien the battery is normal , there is not any sign.

• The connector is for the purpose of connecting with hand ,q Whon the battery is not sufficient,
switch.

@) Standard fixing Hall >the unit occurs with beep and the power cord shape blinks 10 times at the same time and then

• The hall is for the purpose of using with tripod . the power automatically turns off.

) Ill Ille case of No.4) as above, you must charge it with the charger.

1t LCD screen
) v\' lum you turn on the unit, LCD is changed the screen of 3 steps for 5 seconds as under.

'ff'
~OULT
C) ®ffi
m
O Q. 60sec • It is displayed the unit's status and information. lop I

@) Tooth type of exposure object • Company name and software version

eaememE:i
V 1 .0
• • • • • • • They are buttons for selecting tooth of exposure object.

@ Battery replacement cover

'.:'i i

• The cover is use for battery protection and replacement. • Booting of product

Initialization

BEMEMS Co., Ltd.

BPD-I (Rev. 1.5) 18 M•, (o, Ltd BPD-I (Rev. 1.5) 19
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Portable Dental X Portable Dental X
User's Manual
~ .[____ _ _ _ _ _ __ ~ User's Manual

• Step 3
I) •;1,111dard Exposure time

...... -
'ft' C) 11111 1•11111111 Film/

e
..
0 ::-: ;
..

::w: -

'
• Standby for Exposure shot . -"f~- -
0 0.60s! I YI'' Digital

Film 0.50
. .

0.60 0.90 0.35

..

0.40 0.50 0.95

11111.1
Digital 0.15 0.20 0.30 0.10 0.12 0.20 0.50
2. Turn OFF

Film 0.25 0.40 0.55 0.16 0.20 0.25 0.65

If you want to turn off the unit, press the OFF button for 2 seconds. 11111)
Digital 0.08 0.10 0.12 0.07 0.10 0.16 0.30
3. Set of EXPOSURE condition

1) ADULT I CHILD button

I I XI 'OS URE time

If you want to select patient type, press the ADULT/CHILD buttons. 111 wnnt lo change the EXPOSURE time, you can change 56 steps with UP/DOWN buttons

!11 1"""1 the EXPOSURE time

It is displayed the letter and symbol on the screen.
l\11tn111~t1c saving : When you shot the unit after changing the EXPOSURE time on the AUTO mode, it is

2) Tooth type buttons

saved automatically.

M111111al saving: When you shot the unit after changing the EXPOSURE time on the Manual mode, if
Basic set : Select one of 6 type buttons which you want to shot (maxillary front tooth, canine, molar and

you press the SAVE button 2 seconds more, the exposure time is stored.
submaxillary front tooth, canine, molar)
1 '1.J:,111{1

Union set : If you press both maxillary front tooth and submaxillary front tooth at the same time, 1 111 .. 11,111 tho exposure conditions which you want to shot.

11111 1l1qllal senor or film on the opposite side which you want to expose and then contact the unit on the
the symbol is displayed on the screen.

ihJ purl
3) LCD compositions
llio 11xposure button.

, atat11s symbol ~ blinks after 2 seconds.

Powerstatus + - - - - , Power connection
llill oxposure is started, the exposure symbol CIIt is displayed on the LCD. At the same time the
Pahenttype Battery status In yoll11w ,md rings beep.
Detector type
Tooth type thu exposure button for finishing shot which you set the exposure time .

. ,t11yud st;mdby symbol B for 5 seconds after finishing the shot and then you can shot next
EXPOSURE time

BEMEMS Co., Ltd.

BPD-1 (Rev. 1.5) ltd BPD-1 (Rev. 1.5) 21
 Portable Oental X Portable Dental ><

User's Manual User's Manual

~
8) If you fully charge the battery you can shot about 150 times. MODE'' Function

5. Battery Charging and Replacement

memams

-
THE IEST MEDICAL rrtMS
1) Charging

The remained battery's capacity is displayed at the upper right corner of LCD.
0
""

-L---~1~
....._T - I'"\
If the battery's capacity is insufficient, it is effected the image. ThPrPfnre you must always check the battery.
:a-.
If the battery's capacity is not enough, the power cord symbol is blinked 10 times with beep on the 01 · · ·- . 1
0
.. 0....
-
LCD and then the unit automatically is turned off. It takes 3 hours for charging after automatically turn off.
.... BPD-1

2) Replacement

If you have a defective or out of life battery, please contact to BEMEMS Co., Ltd. or the purchase shop for 11p11ms 2 seconds more the "MODE" button at the power on, it changes the set item screen as under.
replacement.

5Mtn I Reset No

ve 10 Min
I Exp. Count 0

·1c1vn Modi! Manual

I 1I) 'lolcct D1grtal

~) Mndo

11;,t! 11(,n1 does not use the unit for the sleep mode time, it automatically is changed sleep mode. When it

""I' 111odo, 11 does not operate the exposure button and the LED blinks green. If you want to change

Liy i,l.ilus , press the MODE button.

Battery replacement cover

·i vo

; 11 11 t 1n doos not use the unit for the power save time, it automatically turns off the power. It is a

li1111 wl11d1 prevents unnecessary electricity from consuming.

BEMEMS Co., Ltd. BPD-1 (Rev. 1.5) Lid BPD-1 (Rev. 1.5) 23
 Portable Dental X
User's Manual User's Manual
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3) Save Mode
l :1wnging Set value at the "'MODE "

It is a function for selecting automatic save or manual save.

4) FI D Select
l!ll!!!mems
TME IEST MEDICAL fJ(M$

It is a function for selecting analog {chemical film) or digital method. 0.

5) Reset 0
OOWN

It is a function for initializing with default.

0....
6) Exp. Count

It shows the total exposure number.

"" BPD-1 -
0

I f you press 2 seconds more the "MODE" button at the power on, it changes the set item screen.

ot,tem
{.""' """'
Power Save

Save Mode
10 Min

15 Min

Manual
Set value

FI D Select Digital
____J

{ Reset No }
ol ,tom
Exp. Count 0
I Set value

i•.. 11111111vornent

l11tli111

• Reset ., F I D Select • Save Mode - Power Save in sequence.

M l,111ton

,1,.,.p Mode • Power Save ~ Save Mode ~ F I D Select • Reset in sequence.

BEMEMS Co., Ltd. BPD-l (Rev. 1.5) 25

BPD-l (Rev. 1.5) I td
 Portable D Portable Dental X-ray Sy
User"s Manual User's Manual
®))
2) From set item to set value movement

, I 1t,l,1ult and range

Press " ADULT" button for moving from set item to set value.

Function Default Range

Set item+>
{ """'""''
Save Mode
Power
Save
10 Min

15 M,n

Manual/Auto
} '""""'
,l•lllP v1ode

J11Jw1ir ~ve
Power saving

Auto power OFF

10 Min

15 Min
5 - 20 Min(1 minute interval)

5 - 40 Min(5 minute interval)

,vu M ,de Automatic or Manual save Manual Manual I Auto

F /0 Select D1g1tal/Film
l>S eel Film or Digital sensor Digital Digital I Film
{ Reset No/Yes } l{IJ' Initialization No No I Yes
Set ,tern+> Set value
Exp Count
Accumulation record
I •1 C .mt Total EXPOSURE number 0
(Max. 99999)

3) Set value change

You can change the set value pressing UP/DOWN buttons at the set value.

{ cs,woMoa, ~ 10 Min

Power Save 15 Min

Set item
Save Mode Manual
} s""''"'
F I D Select Digital

{ Reset No }
Set item I Set value
Exp . Count 0

BEMEMS Co., Ltd. BPD -1 (Rev. 1 ',) .!rl BPD -1 (Rev. 1.5) 27
 Por1able Dental )(
User's Manual User· s Manual

Chapter V. Error Code haptor VI. Unit drawing

When you use the unit, if you have some serious problems, the LCD appears "Error Code " and "Em Unit:mm

174
Contents ·· on the screen. Please contact to BEMEMS Co ., Ltd or the purchasing shop.

Error Code I I
ERROR01
I I

1
Error content ~

Over Current
11
I ti '4
"~'
I I I I I -

Error code table

Error Code Contents
l\
I I
i
I
JI
I I
I I I 11
·over Current· I
•ERROR 01 •
---
·1 I IJ
•ERROR 02· "low kv·
•ERROR 03· "low mA"

"ERROR 04 • "Filament cur

150

EP

:g 11111 111 1
e Ill

BEMEMS Co., Ltd . BPD-1 (Rev I ' BPD -l (Rev. 1.5) 29

 User's Manual User's Manual
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ChapterVII. EMC Information of the BPD-1
i I V11rlations covered by this report

1. General Information of Test M0dul Difference : N/A.

1.1 Standard for Methods of Measurement

Basic Standard Description l\ilrlltlonal information related to Testing

Test Resu lt

General requirements for safety-Collateral standard 1111~ apply only to the particular sample tested and functionality described in this test report. This report
EN 60601-1-2:2007
• Pass o Fa il
Electromagnetic compatibility-Requirements and tests rnproduced in full. Partial reproduction may only be made with the written permission of the BWS Tech
EN 55011 :2009 Industrial, scientific and medical {ISM) radio-frequency
equipment - Radio disturbance characteristics - Limits and • Pass o Fail
+A1 :2010
methods of measurement
EN 61000-3-2:2006
Mains harmonics equipment up to 16A. • Pass o Fall
+A 1:2009+A2:2009 ('I" ,1,rllon Conditions of EUT during Testing
EN 61000-3-3:2008 Voltage fluctuations equipment up to 16A. • Pass o Fa ll
i;_\llll!J Mode
Testing and measurement techniques.
EN 61000-4-2:2009
Electrostatic discharge immunity test. • Pass n Fall
1,1~,lod according to the following operation modes provided by the specifications given by the
EN 61000-4-3:2006+ Testing and measurement techniques. tu"' and reported the worst emissions
A1:2008+A2:2010 Radiated Immunity. • Pass Fall

EN 61000-4-4:2004 Testing and measurement techniques.

11p111.111on Modes Worst Case Mode
+A1:2010 Electrical fast transienVburst immunity test.

Testing and measurement techniques.

lr11111,1I Operation Mode •
EN 61000-4-5:2006
Surge immunity test.

Testing and measurement techniques. il'll•11111 criteria

EN 61000-4-6:2009 Immunity to conducted disturbances induced by radio
• Pass
1ll lu1111Jle to
frequency fields.

Testing and measurement techniques M'II~ SAFETY and ESSENTIAL PERFORMANCE. The following DEGRADATIONS , if
EN 61000-4-8:2010
Power frequency magnetic field immunity test • Pass
111 IJASIC SAFETY and ESSENTIAL PERFORMANCE , shall not be allowed:
Testing and measurement techniques.
EN 61000-4-11:2004 I •·11h1111:.;
Voltage Dips, Short Interruptions and Voltage Variations • Pass
Immunity Tests.
,11 11111111,ible parameters;

1.2 Description of EUT modification ri,il,111lls (MANUFACTURER'S presets);

-N/A ,111,11111ode ;

BEMEMS Co., Ltd. BPD-1 (Rev. 1.5) 31

BPD-1 (Rev. I '•
 Portable Dental )( Portable Dental ><

User's Manual User's Manual

- cessation or interruption of any intended operation , even if accompanied by an alarm ; I l' uwor Line Conducted Emission Tests

d111. tnd Emissions were measured from 150 kHz to 30 MHz with a bandwidth of 9 kHz on the 230V AC
- initiation of any unintended operation , including unintended or uncontrolled motion , even if accompanied
mcl return leads of the EUT according to the methods defined in European Standard EN
an alarm ;
1 t .'ll09+A 1:201 O. The EUT was placed on a nonmetallic stand in a shielded room 0.8 meters above the
- error of a displayed numerical value sufficiently large to affect diagnosis or treatment;
I pl.me as shown in section 3.1.5.

- noise on a waveform in which the noise would interfere with diagnosis, treatment or il'llllc<' cables and equipment positioning were varied within limits of reasonable applications to

1110 the position producing maximum conducted emissions.

monitoring ;

- artefact ~istortion in an image in which the a~fact would interfere with diagnosis ,

I Io, I c o ndition
treatment or monrtQring;

~ , c EQUIPMENT and ME SYSTEMS to diagnose or treat, ev· I 11J1 1111111cy Range of Test 150 kHz to 30 MHz
- failure of automatic diagnosis

accompanied by an alarm . Test Standard EN 55011 :2009+A1 :2010

Test Date February 14, 2013

For EUT with multiple FUNCTIONS , the criteria apply to each
Class A
FUNCTION , parameter and channel. 24' C/ 42 %
ill"" o1 ture/Humidity

The EUT may exhibit DEGRADATION of performance (e.g . deviation from

MANUFACTURER'S specifications) that does not affect BASIC SAFETY or ESSENTIAL PERFORMAN

Frequency Range Limit (dBuV)

(MHz) Quasi-Peak Average-Peak

1.7 Description of Test System (EMI and EMS)
0.15-0.5 79 66
I\
Type of Peripheral Equipment Used: 0.5-30 73 60

0.15-0.5 66-56 56-46

Description Model Name Serial No. Manufacturer 0.5-5 56 46

5-30 60 50
EUT BPD-1 Prototype BEMEMS Co ., Ltd .

Adaptor BPD-AP - BEMEMS Co., Ltd.

Type of Cables Used: Model Manufacture Serial No Cal Due Date Use

ROHDE &
Device from Device to Type of Cable Length(m)
ESPI ' SCHWARZ
100063 01 .17.2014 •

EUT Adaptor DCIN 1.5 I N/A N/A N/A N/A •

BPD -1 (Rev. 1.5) 33
BEMEMS Co., Ltd. BPD -1 (RPV
 Portable Dental X Portable Dental X
User's Manual User's Manual

LISN NSLK8127 SCHWARZBECK 8127-414 01.16.2014 fJ1,111s :

lmpuls-Begrenzer Pulse ROHDE &
ESH3-Z2 100092 01.17.2014
Limiter SCHWARZ M 11q1n = Limit - Emission Level

All 111odes of operation were investigated and the worst-case emissions are reported. See the plots in next
2.1.4 Test Result of Power Line Conducted Emission.

EUT: BDP-1 urement uncertainty estimated at 3 500 dB

Input Voltage : AC230V, 50Hz n1,Jt1,urement uncertainty is given with a confidence of 95.00 % with the coverage factor, k=2.

Power Line Conducted Emission Test Results: PASS

Test data sheets follow

------------ 11ll11tod Emission Tests

I 0111,ssions form 30 MHz to 1000 MHz were measured with a bandwidth of 120 kHz according to the
Correction[dBJ Peak Mode :I 1lotltnes in EN 55011 :2009+A1 :2010. The EUT was placed on a nonmetallic stand in the open-field
Avera;1
Freq Phase
Emission 111olm above the ground plane, as shown in section 3.2.3. The interface cables and equipment
:MHz] Pulse Cable Limit reading Margin Limit
AMN [H/N] Reading
Level WOI!' varied within limits of reasonable applications to determine the positions producing maximum
Limiter Loss
[dBµV] [dBµV] [dBµV] [dB] [dBµV] [dBµV] 1111~~1ons.
0.150 9.66 7.67 0.06 N 32.35 49.74 2.26
0.166 9.66 7.67 r--
0.07 H 33.44 50.84 28.16
,___.
0.206 9.67 7.67 0.08 N 39.09 56.51 22.49
79.00 66.00 t---• I Im I r:ondltion.
0.246 9.66 7.68 0.07 N 23.85 41.26 37.74
0.310 9.66 7.68 1----
0.07 N 38.49 55.90 23.10
0.410 r-- 111u11c:y Range of Test 30 kHz to 1000 MHz
9.66 7.68 0.07 H 40.74 58.15 20.85
Test Standard EN 55011 :2009+A 1:2010

Test Date February 14, 2013

Class A
Correction[dBJ Peak Mode Avr
eq Phase '''I'"': ,tu re/Humidity -1"C/28 %
Emission
~z] Pulse Cable Limit reading Margin
AMN [H/N] Limit Readu 111ul;1rd
Level
Limiter Loss
[dBµV] [dBµV] [dBµV] [dB] [dBµVJ [dBµV Frequency Range Limit (dBuV)
,12 9.67 7.68 0.08 H Ut1111
31.75 49.18 23.82 (MHz) Quasi-Peak Average-Peak
,16 9.67 7.68 c---
0.08 H 32.22 49.65 23.35 30-230 40 N/A
20 9.67 7.68 0.08 H 34.43
~
A
51.86 21.14
,24 9.67
73.00 60.00 ,____ 230-1000 47 N/A
7.68 0.08 H 34.84 52.28 20.72 30-230 30 N/A
,24 9.68 7.68 r--
0.08 H 33.43 50.87 22.13 230-1000 37 N/A
t28 9.68 7.68 0.08 r--
H 29.00 46.45 26.55
l"lt1111n11t List
BEMEMS Co., Ltd. BPD -1 (Rev I Iii! BPD-1 (Rev. 1.5) 35
 Portable D Portable Dent

User's Manua User's Manual

~ - - - - - -~
Equipment Type Model Manufacture Serial No Cal Due Date hooting Mode

Bilog Antenna VULB 9160 SCHWARZBECK 9160-3122 11.22.2013

. 01.16.2014 Ant Cable AMP Emission
EMI Receiver ESVN30 ROHDE & SCHWARZ 832854/010 I 111q110 ncy Reading Polarization Limit Margin
Factor Loss Gain Level
AMPLIFIER 8447F H.P 2805A02893 IMII J [dBµV/] [*H/ .. VJ [dBµV/m] [dB]
[dB] [dB] [dB] [dBµV/m]
Open Site
RG 214/U SUHNER SWITZERLAND 509794 l ,ltl' 4 27 .78 H 12.25 3.78 25.70 40.00 18.10 21.90
Cable_0.5m
1•1·11 4 28.50 H 12.64 3.85 25.68 40.00 19.30 20.70
Open Site SUCOTEST
Hubersuhner 8400/18A lfi(I I H 28.38 H 12.67 4.05 25.60 40.00 19.50 20.50
Cable_33m 18A /
Antenna Master JAC-3 DAILEMC N/A .........-v N/A
~

Antenna Turntable
JAC-2 JAEMC - N/A N/A
Controller
'11wor Frequency Harmonics and Flicker Emission Test

2.2.4 Test Result of Radiated Emission

I'•• ,t Procedure
EUT: BPD-1
I 1oquency Harmonics Tests :
Test distance: 10 m
1110<1 values of the harmonics components of the input current, including line current and neutral

htoll l>r> compared with the limits given in Clause 7 of EN 61000-3-2:2006+A1:2009+A2:2009

Radiated Emission Test Results: PASS

1n~1rn1 Tests:

Test data sheets follow.

, 111q,od,111ce of the test circuit, excluding the appliance under test, but including the internal

1,1 11,n supply source, shall be equal to the reference impedance. The stability and tolerance of the
Charging Mode
lance shall be adequate to ensure that the overall accuracy of 8% 1s achieved during the
Ant Cable AMP Emission
Reading Polarization Limit 1JH111t procedure.
Frequency
Factor Loss Gain Level
[MHz] [dBµV/] [*H/ .. V] [dBµV/m]
[dB] [dB] [dB] [dBµV/m]

31.62 44 .29 v 10.84 1.50 26.52 40.00 30.10

35.24 v 11.40 1.52 26 .36 40.00 21.80 11>llllon

39.16
64.43 38.26 v 10.69 2.68 26.02 40.00 25.60
EUT BPD-1
77.87 43.29 v 8.35 2.82 25.97 40.00 28.50

84.41 42.45 v 7.91 2.89 25.95 40.00 27.30

lost Standard
EN 61000-3-2:2006+A 1 :2009+A2:2009

151.07 28.81 v 1301 3.93 25.65 40.00 20.10 EN 61000-3-3:2008

re st Date February 14, 2013

l lov,ce Class A

1111111 Condition Normal Operation Mode

,111111/llumidity 24.0 "C/42%

BEMEMS Co., Ltd. BPD-1 (Rev. BPD-1 (Rev. 1.5) 37

 User's Manual User's Manua
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2.3.3 Test Equipment List 2 4 2 Test Equipment List

Equipment I quipment Type Model Cal Due Date Use

Model Manufacture Serial No Cal Due Date Use
Type
Compliance California
LSD Simulator ESS-2000 01.18.2014 •
Test System
PACS-3
Instruments
72335 03.02.2013 •
AC Power California 4 ~ Test Result of Electrostatic Discharge Immunity Test
Source
I 15001ix-CTS
Instruments
56255/56256/56257 01.18.2014 •
hostatic Discharge Immunity Test: PASS

2.3.4 Test Result of Power Frequency Harmonics and Flicker Emission Tests q111pment meets the requirements.

Power Frequency Harmonics : PASS

Flicker Emission Tests: PASS I ,1.,1,1 sheet follows

Discharge Type
Test
IOll l'oin t CD=Contact Tested No Observation Result
Voltage(kV)
2.4 Electrostatic Discharge Immunity Test AD=Air
11<.1' CD 2. 4, 6 kV Each 10 times Normal PASS
In order to minimize the impact of environmental parameters on test results, the tests shall be carried ou l 11
< I' CD 2. 4. 6 kV Each 10 times Normal PASS
climatic and electromagnetic reference conditions as specified in EN 61000-4-2:2009.The test programs
2, 4,6, 8
JI C,1·, ' AD Each 10 times Normal PASS
software shall be chosen so as to exercise all normal modes of operation of the EUT. The use of spec111I kV
exercising software is encouraged, but permitted only where it can be shown that the EUT is being 2. 4,6.8
j 1111,pl y AD Each 10 times Normal PASS
comprehensively exercised. The testing shall be performed by direct and indirect application of disch111u kV

the EUT according to a test plan .. 2, 4 6, 8

1·i P•Jr AD Each 10 times Normal PASS
kV
2.4.1 Test Condition CD 2, 4 6kV Each 10 times Normal PASS
,11 1 CD 2, 4. 6kV Each 10 times Normal PASS
EUT BPD-1

Test Standard EN 61000-4-2:2009

Test Date February 14, 2013 ii I mllo-frequency, electromagnetic field immunity test
Evaluate the reponse of the EUT during and aft111 Ill
Performance criterion
in accordance with 2.7. ,111111<:lod in accordance with EN 61000-4-3:2006+A 1:2008+A2:2010 over the frequency range of

Temperature/Humidity/Pressure 24 'C /42%/100.7kPa IIMI I, The transmitting antenna was located 3 meters from the EUT at a height of 1 meter

I I 11111t, sides and back of the EUT were exposed to a uniform field of 3V/m using both
,1111 111 11 antenna polarizations.

BEMEMS Co., Ltd. BPD I (H1•v Itel BPD-1 (Rev. 1.5) 39

 User's Manual User's Manual

~
I usl data sheet follows
2.5.1 Test Condition

F ,quency Field
EUT BPD-1 Position Antenna Result
!ange Strength Modulation
(Angle) Polarity
Test Standard EN 61000-4-3 :2006+A 1:2008+A2:2010 (MHz) (Vim)
J-2500 Front Vertical 3 80 % AM(1 kHz) PASS
Test Date February 14, 2013
J-2500 Rear Vertical 3 80 % AM(1 kHz) PASS
Test field strength(V/m) 3V/m
HJ-2500 Right Vertical 3 80 % AM(1 kHz) PASS
Evaluate the reponse of the EUT during and after these le
HD-2500 Left Vertical 3 80 % AM(1 kH z) PASS
Performance criterion
in accordance with 2.7.
0-2500 Front Horizontal 3 80 % AM(1 kH z) PASS
Temperature/Humidity/Pressure 24 'C/44%/100.8kPa
ll-2500 Rea r Horizontal 3 80 % AM(1 kH z) PASS
ll-2500 Right Horizontal 3 80 % AM(1 kH z) PASS
II 2500 Left Horizontal 3 80 % AM(1 kHz) PASS
2.5.2 Test Equipment List

Manufacture Serial No Cal Due Date UH

Equipment Type Model
,,,,k
ROHDE &
Signal Generator SMT03 826919/008 09 .14.2013 •
SCHWARZ
I i i111o1ry functions as described below were full y fun ctional during and after test.
RF Power 100W 1000M 01 .16.2014
AmplifierReseach 18649
Amplifier 11 ,,1 Operati on Mode
RF Power 1005 01 .162014
5143R OPHIR RF
Amplifier
CBL6140A CHASE 1144 N/A
Bilog Antenna
I h ,11 fast transientiburst immunity test
SCHWARZBECK
BBHA9120
BBHA9120 D MESS- 10.21 .2014
Horn Antenna D 517 1111clucted in accordan ce with EN 61000-4-4 :2004+A 1:2010 .
ELEKTRONIK

Directional 0335214 01 .16.2014

DC6180A AmplifierReseach
Coupler
Directional I !ii i 1 11 11clltlon
DC7144A AmplifierReseach 0334022 01 .16.2014
Coupler
EUT BPD-1

Test Standard EN 61000-4-4 :2004+A 1:2010

2.5.3 Test Result of Radiated, radio-frequency, electromagnetic field immunity test
Test Date February 14, 201 3

Radiated , radio-frequency, electromagnetic Test Voltage Power 2 kV. Signal 1 kV

Evaluate the response of the EUT during and after these

field immunity test : PASS 1
1,rlormance criteri on
tests in accordance with 2.7.

The equipment meets the requirements. 1ru/l lurnid1ly/Pressure 24 'C/46%/ 100.8kPa

BPD -1 (H•, It I BPD -1 (Rev. 1.5) 41

BEMEMS Co ., Ltd.
 User's Manual User's Manual
~
2.6.2 Test Equipment List ,.7.1 Test Condition

Equipment Type Model Manufacture Serial No Cal Due Date Use EUT BPD-1

EMS Immunity Test EMC Pro Test Standard

System Plus
KeyTek 0501285 04.11.2013 • EN 61000-4-5:2006

Test Date February 14, 2013

Test Voltage 1 kV(Une to Une). kV(Line to Ground)

2.6.3 Test Result of Electrical fast transienUburst immunity test
Evaluate the response of the EUT during and after these
Performance criterion
tests in accordance with 2.7.
Electrical fast transienVburst immunity test : PASS
rompera ture/Humidity/Pressure 24 'C/44%/100.8kPa

The equipment meets the requirements .

r ost Equipment List

111lprno at Type Model Manufacture Serial No Cal Due Date Use

Test data sheet follows.
,,. l111m unity EMC Pro
KeyTek
Inject Time I 1ly tern Plus
0501285 04.11.2013 •
Line Voltage Coupling Result
(sec)
L1 2 kV Direct 120 PASS
L2 2 kV Direct 120 PASS l 1, ·• l Result of Surge immunity test

PE 2 kV Direct 120 PASS

11111,nm,ty test: PASS
L1-L2 2 kV Direct 120 PASS
L1-PE 2 kV Direct 120 PASS
The equipment meets the requirements.
L2-PE 2 kV Direct 120 PASS
L 1-L2-PE 2 kV Direct 120 PASS

' 't nll1111t follows

Remarks Inject
Vol tage Coupling Phase(Degree) Result
(count - min)
The primary functions as described below were fully functional during and after test. lkV 18 F 0,90, 180,270 5 times - 5 min PASS
9 F
kV 0,90, 180,270 5 times - 5 min PASS
1. Normal Operation Mode ±100
9 F
kV 0,90, 180,270 5 times - 5 min PASS
±100

2.7 Surge immunity test

Tests were conducted in accordance with EN 61000-4-5:2006. Tests were performed to 1 kV to AC U

Line and 2kV to Line to Ground.

BEMEMS Co., Ltd. BPD-1 (Rev I ltd BPD-1 (Rev. 1.5) 43

 Portable Dental X

User's Manual User's Manual

~
Remarks

The primary functions as described below were fully functional during and after test.
J .8.3 Test Result of Conducted immunity test

1. Normal Operation Mode

, :<lllducted immunity test : PASS

The equipment meets the requirements.

2.8 Conducted immunity test

Tests were conducted in accordance with EN 61000-4-6:2009. Over the frequency range of 150kHz to 80Mlt
t data sheet follows.
Tests were performed at 3 V on power line and signal line.

f roq ,ency Test

Coupling Dwell time Modulation Step Size Res ult
(M fiz) voltage
80%AM
2.8.1 Test Condition 01 i-80 CDN(M3) 3V 3s 1.0% PASS
(1 kHz)

EUT BPD-1

Test Standard EN 61000-4-6:2009 1,,,11ks

Test Date February 14. 2013

Test Voltage
Performance criterion
1i111ary functions as described below were fully functional during and after test.
3V
Evaluate the response of the EUT during and aft111 111111 Operation Mode
tests in accordance with 2.7.

Temperature/Humidity/Pressure 24 ,C/44%1100.8kPa

w,., ltoquency magnetic field immunity test

11111111,mcy magnetic field tests were conducted in accordance with EN 61000-4-8:2010.

2.8.2 Test Equipment List

Model Manufacture Serial No Cal Due Date

Equipment Type 11 ondltion
RF Power 1006 01.18.2014
5085R OPHIR
Amplifier EUT BPD-1
8648A H.P 3642U01639 01.16.2014
Signal Generator
4572 01.16.2014 Test Standard EN 61000-4-8:2010
Attenuator 8325 BIRD
FCC-801-M3- Test Date February 14, 2013
FCC 01044 01.16.2014
CON
16A Test Voltage 3Nm

Test frequency 50 Hz/60 Hz

I 'rn lormance criterion Evaluate the reponse of the EUT during and after these tests

BPD -1 (R1 I Id BPD-1 (Rev. 1.5) 45

BEMEMS Co., Ltd .
 User's Manual User's Manual

~ ---- ...__-,r. t®
in accord ance with 2.7.

Temperature/Humidity/Pressure 25 'c /43%/100.7kPa

2.10.1 Test Condition

EUT BPD-I
2.9.2 Test Equipment List
Test Standard EN 61000-4-11:2004
Equipment Type Model Manufacture Serial No Cal Due Date Use
Test Date February 14, 2013
F-1000-4- Custom
Magnetic Field
8/9/40-L-1M Communications, Inc.
2090 N/A • Voltage Dip > 95%(0.Speriods), 60%(5periods), 30%(25periods)

EMS Immunity Test Voltage Interrupts >95%(5sec)

System
EMC Pro KeyTek 0105254 01.16. 20 14 •
l't'rformance criterion (Voltage Dip) EUT is not life-supporting and for which the rated input
power is greater than 1 kVA and the rated input current is
less th an or equa l to 16 A per phase, deviation from the
2.9.3 Test Result of Power frequency magnetic field immunity test
requirements of 2.7 is allowed
provided the EUT remains safe, experiences no component
Power frequen cy magnetic field immunity test : PASS
failures and is restorable to the pretest state with operator

The equipment meets the requirements. intervention ..

Performance criterion (Voltage EUT is allowed a deviation from the requirements of 2.7,
Interrupts) provided the EUT remains safe, experiences no component
failures and is restorable to the pretest state with operator
Test data sheet follows. intervention.
l,•rnperature/Humidity/Pressure 24 'c/46%/100.7kPa
Magnetic field
Frequency polarity Criteria RI ,auN
strength
50 Hz/60 Hz 3Aim x A I ',
I Ii I I est Equipment List
50 Hz/60 Hz 3A/m y A I',
50 Hz/60 Hz 3Aim z A f-', l:1p,ipm ent Type Model Manufacture Serial No Cal Due Date Use
\~·j 11111 ,unity Test EMC Pro

Remarks
'·y tern Plus
KeyTek 0501285 04.11.2013
•
The primary functions as described below were fully fun ctional during and after test.

1. Normal Operation Mode J'o-1 Result of Voltage Dips and Voltage interruptions immunity test

I llp'i ,ind Voltage interruptions immunity test : PASS

The equipment meets the requirements.

2.10 Voltage Dips and Voltage interruptions immunity test

Voltage variat ions tests we re conducted in accordance with EN 61000-4-11 :2004.

BEMEMS Co., Ltd. BPD -1 (Rt•V Ltd BPD-1 (Rev. 1.5) 47

 Portable Dental X

User's Manual User's Manual

~ ....__......,,, ~
Test data sheet follows
2.11 International Standard EN 60601-1-2

Voltage Dip

Voltage Dip %UT Duration Angle ( •) Result

2.11.1 Guidance and MANUFACTURER'S declaration - ELECTROMAGNETIC EMISSIONS

>95 0.5periods 0,90,180,270 PASS

60 5periods 0,90, 180,270 PASS 1he model AceMobil-510 is intended for use in the electromagnetic environment specified below.

30 25periods 0,90, 180,270 PASS 1he customer or the user of the model AceMobil-510 should assure that it is used in such an
environment.

l 1111ssions test Compliance Electromagnetic environment - guidance

Voltage Interrupts

IH emissions Group 1 The model AceMobil-510 RF energy only for its

Voltage Dip %UT Duration Angle ( •) Result
>95 5sec 0,90, 180,270 PASS
I\PR 11 internal function. Therefore, its RF emissions are

Remarks very low and are not likely to cause any

In the test of voltage dip, the primary EUT was resettled at the test of >95% dip for 5seconds, but the pm11,11 interference in nearby electronic equipment.
functions of EUT were fully functional after test.
P1111ssions Class A The AceMobil-510 must be used only in a
The primary functions as described below were fully functional during and after test.
I'!( 11 (The AceMobil-510 I shielded location with a minimum RF shielding
1. Normal Operation Mode

in combination with I effectiveness and, for each cable that exits the

the shielded I shielded location, a minimum RF filter attenuation

location) of 20 dB from 0.15 MHz to 1,000 MHz.

,11,c emissions I Class A

)ill) 3-2 I I The AceMobil-510, when installed in such a

I" llt1ctuations I Class A shielded location, is suitable for use in all

I C'IIIISSIOns establishments other than domestic and those

l l 3 directly connected to the public low -voltage

BEMEMS Co., Ltd. BPD -1 (RPV. I (I Ltd. BPD-1 (Rev. 1.5) 49

 User's Manual
User's Manual
L __ _ _ _ _~((@
®)
--- power supply network that supp lies buildinq 2.11.2 Guidance and MANUFACTURER'S declaration - ELECTROMAGNETIC IMMUNITY

used for domestic purposes. lh ! model AceMobil-510 is intended for use in the electromagnetic environment specified
ill' ow.
lh ! customer or the user of the model AceMobil-510 should assure that it is used in such
111 environment.
NOTE It is essential that the actual RF shielding effectiveness and filter attenuation of ti 111 nunity test EN 60601 Compliance level Electromagnetic
Test level environment -quidance
shielded location be verified to ensure that they meet or exceed the specified minimum va lu, lit ctrostatic ±2, 4, 6 kV Contact ±2, 4, 6 kV Contact Floors should be wood,
Ii : harge (ESD) concrete or ceramic tile. If
± 2, 4, 6, 8 Kv Air ± 2, 4, 6, 8 kV Air floors are covered with
N 61000-4-2 synthetic material, the relative
humidity should be at least
30%.
It 11cal fast ± 2 kV for power ± 2 kV for power Mains power quality should be
11•,1ent/burst supply lines supply lines that of a typical commercial or
± 1 kV for ± 1 kV for hospital environment.
N 1,1000-4-4 Siana I Siqnal
I•' ± 1 kV line(s) to ± 1 kV line(s) to Mains power quality should be
line(s) line(s) that of a typical commercial or
Cd 000-4-S ± 2 kV line(s) to ± 2 kV line(s) to hospital environment.
Ground Ground
',11 w dips, short > 95 % dip in UT Not applicable Based on EN 60601-1-2 and
- · 11ptions and for 0.5 periods EN 61000-4-11 are not
I HI" variations applicable because the model
n,1w1!r supply 60 % dip in UT AceMobil-510 draws more than
1111 itltPS for 5 periods 16 Amps per phase.

I , 000 4-11 30 % dip in UT

for 25 periods

> 95 % dip in UT
for 5 sec
, Jr.-•quency 3 A/m 3 A/m Power frequency magnetic
' I •I I It ) fields should be at levels
.. :' :: lteld characteristic of a typical
location in a typical
11 I JOO •I 8 commercial or hospital
environment.
I Ill 1, the a.c. mains voltaqe prior to application of the test level.

BPD I Ii I td BPD-1 (Rev. 1.5) 51

BEMEMS Co., Ltd.
 Users Manua
User's Manual
®1
2.11.3 Guidance and MANUFACTURER'S declaration - ELECTROMAGNETIC IMMUNITY by absorption and reflection from structures, objects and people.
Note 2 It is essential that the actual shielding effectiveness and filter attenuation of the
shielded location be verified to assure that they meet the minimum sp_ecification.
The model AceMobil-510 is intended for use in the electromagnetic environment specified below.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
The customer or the user of the model AceMobil-510 should assure that it is used in such an
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
electromagetic environment
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
Immunity test I EN 60601 test Compliance Electromagnetic environment - guidance
environment due to fixed RF transmitters, an electromagnetic site survey should be
level
considered. If the measured field strength outside the shielded location in which the
Conducted RF I 3 Vrms 3 Vrms AceMobil-510 must be used only in a shield AceMobil-510 used exceeds 30 V/m, the AceMobil-510 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
EN 61000-4-6 I 150 kHz to 150 kHz to location with a minimum RF shielding such as relocating the AceMobil-510 or using a shielded location with a higher RF shielding
effectiveness and filter attenuation.

80MHz 80MHz effectiveness and, for each cable that c•11I

the shielded location, a minimum RF filte,

attenuation of 20 dB from 0.15 MHz to

1,000 MHz. See [appropriate section of

ACCOMPANYING DOCUMENTS]. Field

strengths outside the shielded loc<1t11 ,,1

fixed RF transmitters, as determined l,y

electromagnetic site survey, should I

than 30 V/m. a Interference may 0(1111

vicinity of equipment marked

Radiated RF I3VI m 3V/m following symbol:

EN 61000-4-3 I 80 MHz to 80 MHz to

2.SGHz 2.SGHz
<<1>>
Note 1 These guidelines may not apply in all situations. Electromagnetic prop.icJ~I
BEMEMS Co., Ltd. BPD I ([ Co , Ltd.
BPD-1 (Rev. 1.5) 53
 ~ User's Manual
User's Manual
~
ChapterVIII. Life time
Change of characteristic by voltage of filament is as in the following.
1. Object

The purpose of experiment is to get product's confidence with life cycle. The X-ray Tube's life which is key

component has effect on product life. The life time of tube depends on vacuum , target and filament, 111

particular, the filament is finally destroyed by Thermal fatigue. Thermal fatigues can cause damage to t1 1

material and generate a crack by repeated the heating and cooling . Subdivide thermal fatigue into inten11 ,1

constraints, thermal stress fatigue , and thermal mechanical fatigue among them, thermal cyclic fatigue wh11 Ii

occurs in X-ray has effect on life time of Tube .

NcQ· T ! ' l l a ~ ~ ~ ~

When you subdivide thermal fatigue, Thermal stress fatigue by internal constraints and external tho1111

change and The thermal and mechanical changes by external constraints are separated by th11111

mechanical fatigue that is complex repeated . Thermal cyclic fatigue of heating and cooling that "
_b_
Lo (tr (tr. Wa
Wi ( ~'.)
repeatedly during the irradiation of X-ray, it is determined that the influence on the life of the tube LO,L 1 : life time, VO , V1: input voltage, 10,11 : current, WO,W1 : electricity power

ii, b, c is filament index, as appears by these formula , life time is decided in proportion to volt,1CJ11 ol l1l,1111n11I
2. Experiments content and scope 111d current.

Information reviewed through chart and test provided by the manufacturer is as follows
1) Grasp the voltage characteristics of filament.
Filament chart of circuit and product for experiment
2) Analyze filament chart by product.

v111w chart of Tube which is used in our company.

3) Circuit test

4) Test result analyzes and interpretation of life time of Tube.

2.1 The voltage characteristics of filament [Picture.1] Filament characteristic curve used in the 0-0818

In order to review the filament chart of the offered tube and make life test, it is the principle that 1111

Ptt liu n. 1 is filament characteristic curve used in the 0-0818. 0-0818 can irradiate maximum bfllA 111 11111
at the rated voltage . However, this case , to conduct the test time of 10,000 hours seems to b,, vo1

l '/ during 25sec. Therefore , current applied filament is 1.76A and voltage is 2V. Here, to oht.i111 1111
Therefore, the 105 to 160% of the voltage is applied to the filament by a reference voltrnJ•

lorist,c curve by applying a 105% of the voltage 2.1V to the applied voltage .
appearance changes with temperature characteristics of the filament.

BEMEMS Co., Ltd. BPD I (H1 1v M~ Co, Ltd.

BPD I (Rev I ',) •,•.
 Portable Dental X
User's Manual
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~
Picture.3 is current characteristic curves in accordance with the applied voltage of the filament used OX/110-
2.3 Circuit test 15. Maximum tube current of OX/110-15 is 70mA. At this time, applied voltage of filament is 7V. Conduct test

by applying a 7.35V of the voltage 105% of the applied voltage in the same way as the D-081 B.

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[Picture.4] The filament characteristic curve of tube used RAD-85S

[Circuit.1] Filament on /off Test Jig Picture.4 is current characteristic curves 1n accordance with the applied voltage of the filament used RAD-

Make a test jig of [Circuit.1] and then examine certain voltage and period (15Sec On, 15Sec Off). 85S. Maximum tube current of RAD-85S is 120mA. At this time , applied voltage of filament is 13.0V, 3.9A.

Conduct test by applying a 13.65V of the voltage 105% of the applied voltage in the same way as the D-

v 0818.

OI !.§. 15

30s

[Picture.2] On/Off test period

I 1 ..
f I I I I
vi

1~ 11111:1111
10
II "'
i
a ,o ,0

1 I/

. . ,_.....
-/

. .._,...,.
-·- 1
v
I v'

[Picture.3] The filament characteristic curve used OX/110-15

M'i Co., Ltd. BPD -l (Rev. 1.5) 57

BEMEMS Co., Ltd.
 User's Ma a
User's Manual
~
2.4 Test Conclusion and analysis.

ll rJ' :ii:!: l1 10 fJ yj ,, [Table.2] Life cycle according to temperature.

N~ rnl,er of cr~le IN

[Table.1] Temperature characteristic curve in accordance with ON/OFF period of D-0818 [Table.2] is intended to show divided results of life test by repetition ON I OFF of the filaments in each model,

rs expressing the temperature of the filament measured with time. Through these results, it can be expressed
[Table 1] is applying a 105% voltage than the reference voltage to the D-0818 and repeating the ON I 0 1 f
by the following equation.

a fixed period.
Lifetime = 10(C T + DJ
This is temperature characteristic curve through the experiment. The number of repetition is cond11r l

II you check the approximate slope of each product, D-081 B is -0.0067, OX/110-15 is -0.0065, RAD-85S is -
repetition test with 18million times and simply schematizing table1. The experiment repeated 18111111111 I

11 11061. Slope is higher, the life becomes long, it was possible to confirm that there is a difference in the life of
results are shown in diagram1. Our company was measured using radiation thermometer in orde r to '"'

1111 1 product. In conclusion , there is relationship between the temperature of the filament, the higher the ionic
temperature of filament inside tube. When repeated ON I OFF test at a constant period , filaments hns rf

1r1,e, the influence of the thermal fatigue it shows that progressively decreases . Also, as the output is high , it
the preheat temperature, given the thermal shock to be re-cooled . Mean of NB=45, the period of tho l •Ill
Ilsa able to confirm that the thermal fatigue is high.
did not have any change before 45 times. But it changes of temperature characteristic occurs aftor I'
Conclusion
Therefore, rapid change after 45 times is accumu lated thermal fatigue due to continue heating "'"'

and then life will become end

111 X-ray tube is generally difficult to determine the life time separately. We are assumed that the hospital

rr •,nd 100 times per day by patient. Of the 365 days , it is considered to be the use of 260 days excludrng

It can be expressed by a simple equation through curve about thermal fatigue. rH ls and holidays . If so, it will be used 26,000times per year.

T= 2572.624- 147. 706LogN T= temperature of filament, N=ON/OFF period

111pany was tested about ON/OFF period of filament during 180,000 times. Thrs test was constantly
BEMEMS Co., Ltd. BPD I (Rnv I Ml MS Co., Ltd.
BPD I (Rev 1.5) ')!J
 Portable Dental X
User's Manua
~
User's Manual

~
measured temperature of product and it is measured in a range within damage to the filaments.
conducting Aging Test in product inspection condition in order to reduce early failure ratio.

It was tried to estimate the life time under the condition of using each of the products in the hospital. ON/OFF
-Accidental failure period : This is occurred by external factor. It can be seen as faulty occurrence of tube due to
period of filament was divided the number of times that is used in one year at 180,000 times. The result came
the improper pressure of tube and the unstable element occurrence of the voltage applied to the
out the life of about 6.9 years. The life time has been determined to life rather than wear-out failure period, ,tis

used more than those that can also be used. filament. When using product, it can occur accidental failure by external factor due to lightning , unstable power

We have drawn simply norm al life-cycle on the chart. supply input, breakdown of tank etc.

When designing , the company is examining a number of conditions , enter the stance designed to EN60601 -1,
Dereasing Failure Inc reasing Failure
and verify. Also, we were an effort to reduce failure ratio that accidentally occur.

Use life time

-Wear failure period : When life of tube ends and X-ray has not been investigated , tube occur a number of

factors such as damage due to vacuum failure of tube , thermal fatigue of filament etc. product that has

reached the end of life is recording that product is discarded depending on the law of the country in which the

,.,.
j Early
•l <c
Random Failure Wear
customer is using in manual

failure [Table.3] Life cycle of Product

out
The company was verified life of 6.9yea rs only, then the wear-out failure period was not able to grasp the
As appears by [table3], life can be divided into failure, it can be considered in three patterns.
ex1ent of the Tube wear. For this section, the company isn't company to create tube.

Therefore, it isn 't enough to test it while discharging the tube .

Early failure period : It is included vacuum of Tube, oxidation of filament and flaw of Target.

This time is failure period that occur manufacturing problems of the product and raw material of tube , process
This is the end of report for the life of the product.
faulty due to faulty of raw material.

Although period occurring in early failure is about 6months , manufacture of fabri cating the tube has guaranteed

one year (12months). Therefore our company includes warranty period of two ye ars. We have inspected product

BEMEMS Co., Ltd.

BPD -1 (Rev. 1.5) 60 BEMEMS Co., Ltd . BPD I (Rev 1 5) Ci l