097 Belray II Op Manual
097 Belray II Op Manual
097 Belray II Op Manual
097
OPERATOR’S
INSTRUCTIONS
・Wall Mount Type ...................WK
・Floor Mount Type ..................FK1/FK2
・Mobile Type ...........................FM
・Room Mount Type..................RK
・Ceiling Mount Type................CK
0197
WARNING
This X-ray equipment may be dangerous to patients and operators
unless safe exposure factors and operating instructions are observed.
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INDEX
PAGE
[ 1 ] INTRODUCTION .................................................................... 1
[ 8 ] DISPOSAL ................................................................................ 9
[ 10 ] MAINTENANCE ................................................................... 11
[ 1 ] INTRODUCTION
1.GENERAL
BELRAY II 097 is an extraoral source dental radiographic x-ray unit. This unit works as a
diagnostic purpose x-ray source for human teeth with resultant image recorded on intraoral
dental x-ray film or image receptor. This manual provides information for the operation and
maintenance procedures and technical specificaions for BELRAY II 097 dental x-ray unit.
The instructions contained in this book should be thoroughly read and understood before
operation. BELRAY II 097 has no user serviceable items. Only qualified dealer service
personnel should perform maintenance and repairs.
2. PARTS IDENTIFICATION OF X-RAY SYSTEM “BELRAY II 097”
a. Tube housing assembly : 097-H
b. X-ray controls : 097-CM (main controller), 097-CS (sub controller)
c. Cones : 097-R (regular), 097-L (long)
d. Balance arm : 097-A
e. RK stand : 097-RK
3. COMPLIANCE WITH STANDARD
BELMONT BELRAY II 097 x-ray unit complies with the following standard.
EN 60601-1:1990 including A1:93, A2:95 and A13:96, EN 60601-1-3:1994,
EN 60601-2-7:1998, EN 60601-2-28 :1993, EN 60601-2-32:1994.
4. CLASSIFICATION
According to EN60601-1, BELMONT BELRAY II 097 is classified as follows.
a. Protection against electric shock : Class I Equipment, Type B Applied Parts
b. Protection against ingress of water : Ordinary
c. Mode of operation : Continuous Operation with Intermittent Loading
(Duty Cycle = 1 : 50)
d. Equipment not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide.
5. SAFETY
This X-ray Unit may be dangerous to patient and operator, if safe exposure factors and operating
instructons are not observed.
Only qualified and authorized personnel may operate this equipment observing all laws and
regulations concerning protection.
・The operator must at all times remain 6ft. (2m) from the X-ray head for operator protection.
・Fully use all radiation safety features of the equipment.
・Fully use all radiation protection devices, accessories and procedures available to protect the
patient and operator from x-ray radiation.
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6. SYMBOLS
Please use the table below to confirm the meaning of the symbols to be found in this
manual, on the control panel or labels affixed the BELRAY II 097.
Consult written Protection
Instructions in against electric ON (POWER) OFF (POWER)
Manuals shock : Type B
Upper Cuspid
Upper Incisor Upper Molar Occlusal
& Pre Molar
[ 2 ] MAJOR COMPONENTS
1. FLOOR MOUNT TYPE (FK1/FK2)
6 6
1 Main Power Switch
2 X-Ray Head
7 7
8 8 3 Cone
1 1
4 Yoke
5 5
13 15
a b 60 70 4 7
5
C F D kV mA
T1
INC
INC
T2
CUS & PM
CUS & PM
T3
MLR
MLR
T4
BW
P
OCC
T5
13 Arm Collar
3 14 3 6 Balance Arm
9 9 7 Horizontal Arm (300mm)
4 4
2 2 8 Pole Bush
10
10 9 Back Supporter
15
a b 60 70 4 7
C F D kV mA
10
P
T1
INC
INC
T2
CUS & PM
CUS & PM
T3
MLR
MLR
T4
BW
OCC
T5
Pole
14
11 Base Cover
11 11
12 Mounting Plate
12 12 13 Main Controller
14 Sub Controller
15 Hand Exposure Switch
-2-
2. MOBILE TYPE (FM)
1 Main Power Switch
2 X-Ray Head 6
3 Cone
4 Yoke 7
5
5 Arm Collar
6 Balance Arm 3
7
C
a
F
b
D
60 70
kV
4 7
mA
16
Pole Bush T1
INC
INC
T2
CUS & PM
CUS & PM
T3
MLR
MLR
T4
BW
P
OCC
T5
8 4
Pole 2
9 Pole Base 15
10 Leg Bar (long)
11 Leg Bar (Short)
8
12 Lock Caster
13 Standard Caster 1
14 Main Controller 14
15 Sub Controller 10 9
10
16 Hand Exposure Switch
CAUTION
11
Balance arm should be held closed whilst 12
11
moving mobile type (FM) X-ray.
13
8 16 17 3 Cone
4 Yoke
6 9
5 Arm Collar
5 10
a b 60 70 4 7
C F D kV mA
11 T1
INC
INC
T2
CUS & PM
CUS & PM
T3
MLR
MLR
T4
BW
P
OCC
T5
6 Swing Arm 1
4 7 Swing Arm 2
8 Sliding Post
9 Column Cover
12
2 3 10 Colum
11 Backrest Cushion
1
12 Seat
13 13 Gas Pump
15 14 Base Plate
14
15 Main Controller
16 Sub Controller
17 Hand Exposure Switch (Option)
Fig.2-3 Major Components for RK
-3-
4. WALL MOUNT TYPE (WK)
F
b
D
60 70
kV
4 7
mA
5 Arm Collar
P
T1
INC
INC
T2
CUS & PM
CUS & PM
T3
MLR
MLR
T4
BW
OCC
T5
6 Balance Arm
7 Horizontal Arm
5 8 Main Controller
9 Sub Controller
4 7
1 10 Hand Exposure Switch (Option)
2 8
3
13
17
C C S& M
9
INC CUS & PM MLR BW
16 Cover Ring
14 1 10 Light Arm (Option)
8 11 Ceiling Pole
15 12 Ceiling Cover
C F kV mA
MLR
13 Ceiling Mounting Plate
7
T1 T2 T3 T4 T5
14 Sub Controller
5
15 Hand Exposure Switch(Option)
4 16 Support Ring
2 17 Main Controller
3
-4-
10 11 12 16 13 14
1
3
15
4
9
5
6
8
7
17
2 18
(1) Sub Controller Front Panel (10) Cone Type Selection Switch
(2) Ready Light (11) Film Speed Selection Switch
(3) Exposure Time Adjusting Switch (Down) (12) Digital Imaging Switch
(4) Exposure Time Adjusting Switch (Up) (13) 4mA Selection Switch
(5) Tooth Selection Switch (T1) (14) 7mA Selection Switch
(6) Tooth Selection Switch (T2) (15) Patient Size Selection Switch
(7) Tooth Selection Switch (T3) (16) Exposure Time Display Window
(8) Tooth Selection Switch (T4) (17) Exposure Warning Light
(9) Tooth Selection Switch (T5) (18) Exposure Switch
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[ 3 ] FUNCTION OF CONTROLS
(1) Main Power Switch
Pushing the upper side of this switch to the ON position energizes the x-ray unit. (Ready light
and pre-select lights for cone type, film or digital, 4mA, 7mA and patient size illuminate.)
It is recommended to keep this switch OFF when the unit is not in use, in order to prevent an
accidental exposure.
IMPORTANT : To prevent the risk of an accidental exposure, push the lower side
of this switch to the OFF position, when the unit is not in use.
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TABLE 1. Speed Setting and Exposure Time (Regular Cone) [unit : sec.]
Speed Child Adult Large Adult
mA
Setting T1 T2 T3 T4 T5 T1 T2 T3 T4 T5 T1 T2 T3 T4 T5
4 0.20 0.32 0.40 0.50 0.80 0.32 0.50 0.63 0.80 1.25 0.40 0.63 0.80 1.00 1.60
F.09
7 0.10 0.20 0.20 0.32 0.40 0.20 0.32 0.40 0.50 0.63 0.20 0.40 0.40 0.63 0.80
4 0.08 0.13 0.16 0.20 0.32 0.13 0.20 0.25 0.32 0.50 0.16 0.25 0.32 0.40 0.63
F.04
7 0.05 0.08 0.10 0.13 0.16 0.08 0.13 0.16 0.20 0.32 0.10 0.16 0.20 0.25 0.32
4 0.06 0.10 0.10 0.16 0.20 0.10 0.16 0.20 0.25 0.40 0.10 0.20 0.25 0.32 0.40
d.06
7 0.03 0.05 0.06 0.08 0.13 0.05 0.08 0.10 0.13 0.20 0.06 0.10 0.13 0.16 0.25
TABLE 2. Speed Setting and Exposure Time (Long Cone) [unit : sec.]
Speed Child Adult Large Adult
mA
Setting T1 T2 T3 T4 T5 T1 T2 T3 T4 T5 T1 T2 T3 T4 T5
4 0.40 0.63 0.80 1.00 1.60 0.63 1.25 1.25 2.00 2.50 0.80 1.25 1.60 2.00 3.20
F.09
7 0.25 0.40 0.50 0.63 1.00 0.40 0.63 0.80 1.00 1.60 0.50 0.80 1.00 1.25 2.00
4 0.16 0.25 0.32 0.50 0.63 0.25 0.50 0.50 0.80 1.00 0.32 0.50 0.63 1.00 1.25
F.04
7 0.10 0.16 0.20 0.25 0.40 0.16 0.25 0.32 0.40 0.63 0.20 0.32 0.40 0.50 0.80
4 0.13 0.20 0.25 0.32 0.50 0.20 0.32 0.40 0.50 0.80 0.25 0.40 0.50 0.63 1.00
d.06
7 0.06 0.13 0.13 0.20 0.25 0.10 0.20 0.25 0.32 0.40 0.13 0.25 0.25 0.40 0.50
NOTE : Setting or adjusting the exposure time manually (with or switch) supersedes
(5) ~ (15) functions.
-7-
[ 4 ] OPERATING PROCEDURES
1. Turn ON the Main Power Switch (1).
2. Confirm that Ready Light (2) is illuminated.
NOTE : The ready light will not illuminate unless the incoming line voltage is
correct and within the x-ray’s operable range (207 ~ 253VAC).
3. Select the appropriate tooth type (5) ~ (9), and confirm the pre-selected conditions (cone type, film
or digital, mA and patient size) are suitable for exposure.
NOTE : To manually set the exposure time, depress either of the manual Exposure Time
Adjusting Switches ( or ) until the desired exposure time appears in the Exposure
Time Display Window (16). While the unit is in manual mode, other selection switches
(5) ~ (15) do not affect exposure time. (All of the tooth selection lights are off.)
To return to the automatic exposure time selection mode, depress any one of the Tooth
Selection Switches (5) ~ (15).
4. Depress the Exposure Switch (18). When the Exposure Switch is depressed, the Exposure Warning
Light (17) illuminates and the audible warning sounds. Do not release the Exposure Switch until the
Exposure Warning Light and audible warning automatically shut off. Failure to keep the switch
depressed will result in exposure being terminated prematurely.
5. To continue to radiograph other teeth, just select appropriate Tooth Selection Switches (5) ~ (9).
IMPORTANT : To protect x-ray tubehead from heat accumulation, wait for a time interval
that is equal to 50 times the selected exposure time before making additional exposures.
(Example : a 25 sec. wait is necessary between exposures that are 0.5 sec. in duration.)
6. Turn OFF the Main Power Switch (1) in order to prevent accidental exposures when the unit is
not in use.
NOTE : If the unit left over 8 min. without being operated and the Main Power Switch (1) is
kept on, figure “ 1” runs through the Exposure Time Display Window (16). This does
not mean that malfunction of the unit has occurred ; this is an energy saving feature.
The unit returns to ready condition by pressing any one of the switches, except the
Exposure Switch (18).
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[ 7 ] DISINFECTION AND CLEANING
1. DISINFECTION
(a) X-ray operator is required to wear disposable gloves when taking radiographs and handling
contaminated film covers or digital detector covers. Gloves should be changed for each
patient to avoid cross contamination. X-ray head, main controller and sub controller should
be covered by single use barriers.
(b) If you use film holders or digital detector holders that go into the patient's mouth, these must
be sterilized. Follow the sterilization procedures indicated by each manufacturer.
2. CLEANING
In order to ensure proper hygiene and cleaning of the equipment, the following procedures
must be followed:
CAUTION
Before cleaning the unit, turn off the main power switch and breaker on the branch line.
This is required because some internal parts remain connected to main voltage even when
the main power switch has been turned off.
Never use the metal corrosive disinfectant, such as povidone iodine or sodium hypochlorite.
Do not pour or spray solvent or liquid directly on the x-ray unit.
Be careful not to allow solvents to run or drip into the x-ray unit.
Limitations on reprocessing : Repeated processing has minimal effect on these instruments. End
of life is normally determined by wear and damage due to use.
Point of use : Remove excess soil with disposable cloth / paper wipe.
Preparation for cleaning : Turn off the main power switch and breaker on the branch line.
Disassembly is not required.
Cleaning : Wipe the outside surface with a paper towel dampened with a disinfectant solution or
household, non abrasive cleaner.
Disinfection : To ensure proper cleaning of the parts in contact with skin, periodic disinfection
with a non corrosive surface disinfectant is recommended.
Recommended disinfectant : FD333 (Durr Dental GmbH)
Drying : Allow surface to air dry before turning breaker and main switch back on.
[ 8 ] DISPOSAL
1. Disposal of x-ray unit or components
As the tube head of this x-ray unit contains the lead for x-ray shield and oil for the insulation,
this unit cannot be thrown away as the household garbage. Cleaning and disinfection are
necessary before the uint is disposed in accordance with all current applicable regulations and
local codes. In EU area, EU directive 2002/96/EC on waste electrical and electronic equipment
(WEEE) is applied on this product. In this directive, environment conscious recycling /
abandonment is obligated.
2. Disposal of used film and CCD cover
Dispose the used film covers and CCD sensor covers appropriately, according to procedures
indicated by each manufacturer and all current applicable regulations and local codes.
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[ 9 ] ERROR CODES
If an abnormal condition exists in the unit, or a malfunction occurs, an error code is displayed in
the Exposure Time Display Window (16). Please refer to the Table below.
Error
Condition Step to be Taken Possible Solution
Code
All the tooth selection Release the exposure
Exposure switch was released before lights blink. switch after the
E.00
exposure termination. Depress one of the exposure light turns
tooth switches. off.
There should be a
Exposure switch was depressed within "wait" interval of 50
times the exposure time
10 sec. of previous exposure. between successive
exposures.
E.01
A 10 sec. delay is Wait a minimum 3 sec.
Exposure time was set and exposure switch
built in between each after the main power
was depressed within 3 sec. of the power switch is turned on before
exposure. pressing the exposure
switch being turned on.
switch.
Release the exposure
switch. Confirm the ready lamp
Line voltage was less than 90% of rated is ON before exposure.
E.02 Ask service personnel
voltage.
to check the line voltage.
Line voltage was more than 110% of rated Confirm tha ready lamp
voltage. is ON before exposure.
E.03 Ask service personnel
to check the line voltage.
-10-
Error
Condition Step to be Taken Possible Solution
Code
Turn off the main power
switch and wait for Contact customer
Failure of electrical communication between approximately 2 min.
E.22 service
the power PCB and timer PCB. Turn on the main power
switch again.
Any switch on the sub controller is depressed Release all the Do not turn on the
E.23 when the main power switch is turned on. switches power while other
(Except the exposure switch) switch is depressed.
[ 10 ] MAINTENANCE
BELRAY II 097 x-ray unit requires post installation confirmation and periodic maintenance
checks to be performed by dealer service personnel. These procedures ensure that the x-ray
unit is functioning within the manufacture’s specifications and remains in compliance with
the Standard.
It is responsibility of the owner of the unit to see that these maintenance checks are done
once a year and that they are performed by a trained, certified service technician.
The specific instructions to perform these checks are located within the BELRAY II 097
Installation Manual.
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[ 11 ] TECHNICAL DATA
1. Nominal focal spot value ............................................ 0.7 mm (IEC60336)
2. Rated peak tube potential ............................................ 70 kV
3. Rated tube current ....................................................... 4 mA / 7 mA selectable
4. Maximum rated peak tube potential ........................... 70 kV
5. Electrical ratings
a) Rated Line Voltage ................................................. 230 V
b) Min Line Voltage ................................................... 207 V
c) Max Line Voltage .................................................. 253 V
d) Rated Line Power .................................................. 0.8 kVA
e) Rated Line Current ................................................ 3.4 A at 70 kV(peak), 7 mA
f) Max Line Current .................................................. 3.7 A at 70 kV(peak), 7 mA
( Internal Resistance ......................................... 1.33Ω max.)
g) Range of Line Voltage Ragulation ....................... 0 ~ 2 %
6. Power line frequency .................................................. 50 Hz
7. Line power(Long term rating)..................................... 12VA
8. Exposure time ............................................................. 0.02 ~ 3.2 sec. (ON and OFF are zero crossed.)
9. Timer accuracy ............................................................ ±1 pulse (= 1/50sec.)
10. Inherent filtration ........................................................ 1.7 mmAl Equivalent
11. Added filtration ........................................................... 0.5 mmAl
12. Minimum filtration permanently in useful beam ........ 2.2 mmAl Equivalent at 70 kV(peak)
13. Nominal roentgen output 4 mA 7 mA
a. Distal end of regular cone ........................................... 4.2 mGy/sec. 7.1 mGy/sec. ±40 %
b. Distal end of long cone ............................................... 1.9 mGy/sec. 3.3 mGy/sec. ±40 %
14. Cone Source to skin distance Field size
a. Regular cone................................................................ 204 mm 58mm dia., circular
b. Long cone(Option)...................................................... 305 mm 58mm dia., circular
15. Leakage technique factor ............................................ 70 kV(peak) / 494 mAs at 1 hous
16. Duty cycle ................................................................... 1 : 50 (0.5 sec. exposure with 25 sec. interval)
17. Source to the base of cone distance ............................ 81 mm
18. Reference current time product ................................... 22.4 mAs (70 kV(peak), 7 mA, 3.2 sec.)
19. Maximum earth leakage current ................................. 0.5 mA
20. Tolerance of the focal spot marking ............................ ±1 mm
21. Target angle and material .............................................16 ± 1°, Tungsten
22. Maximum anode heat content......................................4.3kJ (6kHU)
23. Maximum x-ray tube assembly heat content ...............150kJ (210kHU)
24. Nominal electrical output of H.V.Generator ...............0.36kW at 70kV , 7mA
25. Measurement base of technique factors
Focal spot marking
Reference axis
a. Peak tube potential ................................................... Peak tube potential of conducting half cycle
b. Tube current ............................................................. Average of tube current during one cycle of
line frequency
c. Exposure time........................................................... Impulses of power line frequency
26. Environmental condition for storage............................-20 ~ 70℃, 10 ~ 90%, 500 ~ 1060 hPa
27. Environmental condition for operation........................10 ~ 40℃, 30 ~ 75%, 700 ~ 1060 hPa
28. Rotation angle of head ................................................ Horizontal 0 ~ 600°, Vertical 0 ~ 300°
29. Service Life..................................................................10 Years
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[12] ELECTROMAGNETIC COMPATIBILITY(EMC)
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.
Portable and mobile RF communications equipment can affect medical electrical equipment. The equipment or system
should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or
system should be observed to verify normal operation in the configuration in which it will be used.
-13-
Guidance and manufacture’s declaration – electromagnetic immunity
The BELRAY II 097 is intended for use in the electromagnetic environment specified below. The customer or
the user of the BELRAY II 097 should assure that it is used in such an environment.
Compliance
Immunity test IEC 60601 test level Electromagnetic environment - guidance
level
Portable and mobile RF communications equipment
should be used no closer to any part of the
BELRAY II 097, including cables, than the
recommended separation distance calculated from
the equation applications to the frequency of the
transmitter.
-14-
Recommended separation distances between
Portable and mobile RF communications equipment and the BELRAY II 097
The BELRAY II 097 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the BELRAY II 097 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the BELRAY II 097 as recommended below, according to the maximum output power of the communications
equipment.
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-16-
NOTE
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EC REP