Installation and Operation Instruction
DX-073 ·Wall Mount Type ...WK
·Ceiling Mount Type ...CK ·Floor Mount Type ...FK1/2 ·Mobil Mount Type ...FM ·Room Mount Type ...RKII
OPERATOR'S INSTRUCTIONS 0197
This X-ray equipment may be dangerous to patients and operators unless safe exposure factors and operating instructions are observed.
TABLE OF CONTENTS [ 1 ] INTRODUCTION --------------------------------------------------------- 1 [ 2 ] OVERALL VIEW AND MAJOR COMPONENTS ------------------ 2 [ 3 ] FUNCTION OF CONTROLS ------------------------------------------- 3 [ 4 ] OPERATING PROCEDURE -------------------------------------------- 4 [ 5 ] MAINTENANCE --------------------------------------------------------- 4 [ 6 ] FILM SPEED CHECKING AND SETTING -------------------------- 5 [ 7 ] DIGITAL IMAGING SYSTEM ----------------------------------------- 7 [ 8 ] CLEANING AND DISINFECTION ------------------------------------ 7 [ 9 ] DISPOSAL OF USED FILM AND CCD COVERS------------------ 7 [ 10 ] ERROR INDICATION -------------------------------------------------- 8 [ 11 ] ELECTRICAL AND RADIATION DATA --------------------------- 9 [ 12 ] ELECTROMAGNETIC COMPATIBILITY ------------------------ 10
Intended Use of the Product This product is an active device intended to emit ionizing radiation for the exclusive use for diagnoses of dentistry, and must be operated or handled by the qualified personnel only. Such qualified personnel should instruct and/or assist the patient to approach to and leave from the product. Patients should not be allowed to operate or handle the product. It is always recommended that both operator and patient use the proper protective means for radiographying.
[ 1 ] INTRODUCTION 1. GENERAL SEARCHER70 DX-073 is a 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 specifications for SEARCHER70 DX-073 dental x-ray. The instructions contained in this book should be thoroughly read and understood before operation. SEARCHER70 DX-073 has no user serviceable items. Maintenance and repair should be performed by qualified dealer service personnel. 2. PARTS IDENTIFICATION OF X-RAY SYSTEM “SEARCHER70 DX-073” a. Tube housing assembly : 073-H b. X-ray controls : 073-C c. Cones : 073-R d. Balance arm : 073-A e. RK stand : 073-RK 3. COMPLIANCE WITH STANDARD BELMONT SEARCHER70 DX-073 x-ray unit complies with the following standard. EN60601-1 : 1990 including A1:93, A2:95 and A13:96 , EN60601-1-3 : 1994, EN60601-2-7 : 1998, EN60601-2-28 : 1993, EN60601-2-32 : 1994. 4. CLASSIFICATION According to EN60601-1, BELMONT SEARCHER70 DX-073 is classified as follows. a. Protection against electric shock : Class I Equipment, Type B Applied Parts b. Protection against ingress of water : Ordinary : Continuous Operation with Intermittent Loading c. Mode of operation (Duty Cycle = 1 : 60) d. Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. -1A-
5. SYMBOL In this book, on the labels or on the control panel of SEARCHER70 DX- 073, following symbols are used. Confirm the meaning of each symbols.
Consult written Instructions in Manuals
Protection against electric shock : Type B
Separate Collection for Electrical and Electronic Equipment
Upper Cuspid & Pre Molar
Lower Cuspid & Pre Molar
Date of Manufacture
Authorized Representative in The European Community
[ 2 ] OVERALL VIEW AND MAJOR COMPONENTS 11
DX-073 70kVp 10mA
2 3 4 5 6
Hand exposure switch Main power switch Tooth selection switch T1 Tooth selection switch T2 Tooth selection switch T3 Tooth selection switch T4
7 7 8 9
10 11 12
Tooth selection switch T5 Patient selection switch V. ready lamp Exposure warning lamp Tooth selection indicating lamps Patient type indicating lamps
[ 3 ] FUNCTION OF CONTROLS 1
HAND EXPOSURE SWITCH Deadman type exposure switch. When making an exposure, depress this switch until both the
exposure warning lamp 10 and the audible warning terminate. Failure to keep the switch depressed will result in premature termination of the exposure.
MAIN POWER SWITCH
When this power switch is turned on, V.ready lamp 9 and one of patient type indicating lamps 12
should come on.
TOOTH SELECTION SWITCH T1 (Incisor of mandible or bitewing of premolars)
TOOTH SELECTION SWITCH T2 (Incisor of maxilla or cuspid and premolars of mandible)
TOOTH SELECTION SWITCH T3 (Cuspid and premolar of maxilla, molars of mandible or bitewing of molars)
TOOTH SELECTION SWITCH T4 (Molars of maxilla)
TOOTH SELECTION SWITCH T5 (Occlusal) NOTE : Angles indicated beside the pictographs of teeth are the standard head angle with bisecting technic when the occlusal plane of patient is horizontal.
PATIENT TYPE SELECTION SWITCH
V. READY LAMP V. ready lamp indicates that the line voltage is within the rated voltage ±10%. DX-073 control
box is designed as exposure cannot be made, if the line voltage is higher than this range. If the line voltage exceeds this range, compensate the voltage by an additional transformer.
10 EXPOSURE WARNING LAMP
Illumination of this lamp indicates the unit is producing x-radiation.
11 PATIENT TYPE INDICATING LAMP
This lamp indicates whether adult or child is selected as patient type. When power switch is
turned on, adult is selected automatically.
12 TOOTH SELECTION INDICATING LAMPS
[ 4 ] OPERATING PROCEDURE CAUTION: The operator must have full view of patient and control panel, and must avoid
exposure to the primary beam. 1. Turn main power switch 2 ON and confirm following lamps are illuminated. a. V. ready lamp 9 b. Patient type indicating lamp (Adult) 12 If the film speed programed in secondary mode is sed, press T4 and T5 switches together for one seconds, and confirm that the indicating lamps flashed. 2. If the patient is a child, push the patient type selection switch 8 . 3. Select a suitable tooth switch 3 ~ 7 . 4. Set the x-ray head in the position. X-ray head can be rotated 600 degrees horizontally and 300 degree vertically. 5. Depress an hand exposure switch 1 . When the exposure switch is depressed, the exposure
warning lamp 10 will illuminate, and the audible warning will sound. Do not release the exposure switch until the audible warning and warning lamp terminate. Failure to keep the switch depressed will result in the exposure being terminated prematurely. 6. After use turn the main power switch 2 OFF in order to prevent accidental exposure. NOTE : 1. Control box calculates the mAs value according to the settings of switches for patient type and tooth type and film speed. This calculation is based on the condition that the cone end is touching to the skin of patient. 2. The operator should make exposures under the condition regarding the duty cycle 1 : 60 (1 sec. exposure with 60 sec. interval) in order to prevent the temperature of insulated oil inside x-ray head from rising over 80°C when the films are exposed continuousl . 3. DX-073 x-ray is designed with its technology of microprocessor controlled mAs system. The tube current is changed by the power supply voltage.
[ 5 ] MAINTENANCE SEARCHER70 DX-073 x-ray unit requires the following periodic maintenance checks being performed to ensure the unit is functioning within manufacturer's specifications. It is the responsibility of the owner of the unit to see that these maintenance checks are done once every 6 months and that they are performed by a trained certified service technician. A. Inspection of arm and head movement B. Inspection of line voltage and line voltage regulation C. Inspection of tube current D. Mechanical safety (Wall Mounting Type) 1. The wall plate should be checked to confirm that it is securely attached to the wall 2. The arm mounting bracket should be checked to confirm that it is securely attached to the wal mounting plate. The arm mounting bracket must be level horizontally and vertically. 3. Check and verify that the horizontal arm is not raising up and out of the arm mounting bracket. This should be verified routinely by treatment room personnel. -4A-
[ 6 ] FILM SPEED CHECKING AND SETTING
SEARCHER70 DX-073 Dental X-Ray System is normally factory set to program #8 to suit D speed film (equivalent to Kodak Ultra-Speed film). When the main power switch is turned ON program#8 is automatically selected as the primary program. A secondary film density program is also usually set into the memory. To select the secondary program, press both tooth selection switches T4 and T5 at the same time for 1 second. The tooth selection lamp will flash indicating the secondary program is now selected. Usually the secondary program will be factory set to #3 which is suitable for F/E speed film (equivalent to Kodak InSight film). To turn OFF the secondary program and return to the primary program simply press T4 and T5 at the same time for 1 second or turn OFF the main power switch. To verify which primary program has been set press T4 while turning on the main switch, compare the sequence of illuminated tooth lamps to the film speed lamp chart to find the selected program. (ie, program #8 has T1 lit only). If no program change is required simply turn the main switch OFF and back on, the system is ready to use. To set new primary program into memory select the required T1 to T4 switches by the film speed & lamp chart and as they are pressed this will turn on or off each lamp to select a desired program. Touch the patient type switch to set the program into memory. Turn the main switch OFF and back on again, the system is now ready to use. To verify and set the secondary program use the same procedures but press T5 while turning ON the main switch, the lamps will flash while illuminated indicating you are in the secondary program. NOTE : The lamps of the patient type switch will flash alternately when the control is put in the verify/set mode. TABLE 1. FILM SPEED & LAMP COMBINATION CHART
Tooth Selection Indicating Lamp T1 T2 T3 T1
#0 #1 #2 #3 #4 #5 #6 #7 #8 #9 #10 #11 #12 #13 #14 #15
F/E speed film : Kodak InSight
D speed film: Kodak Ultra-Speed
TABLE 2. STANDARD mAs VALUE
0.36 0.43 0.52 0.61 0.74 0.88 1.06 1.28 1.53 1.84 2.20 2.63 3.15 3.76 4.50 5.40 0.22 0.26 0.31 0.37 0.44 0.53 0.64 0.77 0.92 1.10 1.32 1.58 1.89 2.26 2.70 3.24
#0 #1 #2 #3 #4 #5 #6 #7 #8 #9 #10 #11 #12 #13 #14 #15 #0 #1 #2 #3 #4 #5 #6 #7 #8 #9 #10 #11 #12 #13 #14 #15
0.60 0.72 0.87 1.02 1.23 1.47 1.77 2.13 2.55 3.06 3.66 4.38 5.25 6.27 7.50 9.00 0.36 0.43 0.52 0.61 0.74 0.88 1.06 1.28 1.53 1.84 2.20 2.63 3.15 3.76 4.50 5.40
0.72 0.86 1.04 1.22 1.48 1.76 2.12 2.56 3.06 3.67 4.39 5.26 6.30 7.52 9.00 10.80 0.43 0.52 0.63 0.73 0.89 1.06 1.27 1.53 1.84 2.20 2.64 3.15 3.78 4.51 5.40 6.48
0.96 1.15 1.39 1.63 1.97 2.35 2.83 3.41 4.08 4.90 5.86 7.01 8.40 10.03 12.00 14.40 0.58 0.69 0.84 0.98 1.18 1.41 1.70 2.04 2.45 2.94 3.51 4.20 5.04 6.02 7.20 8.64
1.40 1.68 2.03 2.38 2.87 3.43 4.13 4.97 5.95 7.14 8.54 10.22 12.25 14.63 17.50 21.00 0.84 1.01 1.22 1.43 1.72 2.06 2.48 2.98 3.57 4.28 5.12 6.13 7.35 8.78 10.50 12.60 [unit : mAs]
NOTE 1 : mAs is the product of tube current in mA and exposure time in second. NOTE 2 : The power is applied to x-ray head during the pre-heating time and the exposure time. The buzzer in the control box beeps during the power is applied to the x-ray head. -6-
[ 7 ] DIGITAL IMAGING SYSTEM If electrical instruments such as a digital imaging system is used with SEARCHER70 DX-073 x-ray, the following points should be confirmed to keep electrical safety.
CAUTION The use of ACCESSORY equipment not complying with the equivalent safety requirements of SEARCHER70 DX-073 may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include : use of the accessory in the PATIENT VICINITY evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate EN60601-1 and/or EN60601-1 harmonized national standard.
[ 8 ] CLEANING AND DISINFECTION In order to ensure proper hygiene and cleaning of the equipment, the following procedures must be followed :
WARNING Before cleaning the unit, turn off the main power switch and beaker 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 blanch 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 tuning breaker and main switch back on.
[ 9 ] DISPOSAL 1. Disposal of x-ray unit or components The tube head of this x-ray unit contains the lead for x-ray shield and oil for the insulation. When disposing the x-ray unit or components, appropriately dispose complying 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 of used film covers and CCD sensor covers appropriately, accoring to procedures indicated by each manufacturer and all current applicable regulations and local codes. -7B-
[ 10 ] ERROR INDICATION
When abnormal condition exists in the unit or malfunction occurs, the tooth selection indicating lamp blinks and the audible warning sounds. In that case, turn off the main power switch and wait for a while. Turn on the main power switch again and if same indication is displayed, call service personnel. Blinking lamp of Teeth T1
Step to be taken
Tube current is detected after the Turn OFF the main power If same error is displayed, switch and wait for a while. call service personnel. exposure time is over. Turn ON the main power switch again.
Wait a minimum 3 sec. switch and wait for a while. after the main power switch is turned ON Turn ON the main power before pressing the switch again. exposure switch.
Exposure switch is being depressed when power switch is turned ON.
Turn OFF the main power
Tube current is detected when main power switch is turned ON.
Turn OFF the main power
During the exposure, tube current
Memory data error.
If same error is displayed, switch and wait for a while. call service personnel. Turn ON the main power switch again.
becomes less than 1 mA.
[ 11 ] ELECTRICAL AND RADIATION DATA 1. Focal point measurement ... 0.8 mm (IEC60336) 2. Rated peak tube potential ... 70 kV(peek) 3. Rated tube current ... 10 mA 4. Maximum rated peak tube potential ... 70 kV(peek) 5. Electrical ratings a) Rated line voltage ... 230 V b) Minimum line voltage... 207 V c) Maximum line voltage... 253 V d) Rated line current... 4.8 A e) Maximum line current... 5.9 A f) Range of line voltage ragulation... 0 ~ 3 % 6. Exposure time ... 0.22 ~ 21.0 mAs (ON and OFF are zero crossed.) 7. Timer accuracy ... ±1 Pulse (Less than 0.2 sec. at 10 mA) ±10 % (0.2 sec. or more at 10 mA) 8. Inherent filtration ... 1.3 mmAl Equivalent 9. Added filtration ... 0.8 mmAl Equivalent 10. Minimum filtration permanently in useful beam ... 2.1 mmAl Equivalent at 70 kV(peek) 11. Source to skin distance ... 200 mm 12. Source to the base of cone distance ... 63 mm 13. Cone length ... 148.5 mm 14. Field size ... 58 mm dia. 15. Leakage technique factor ... 70 kV(peek)/0.16 mA (0.16 mA is maximum rated continuous current for 10 mA with duty cycle 1:60) 16. Duty cycle ... 1:60 (1 sec. exposure with 60 sec. interval) 17. Environmental condition for storage... -20 ~ 70°C, 10 ~ 90%, 500 ~ 1060hPa 18. Environmental condition for operation... 10 ~ 40°C, 30 ~ 75%, 700 ~ 1060hPa
19. Movable range of head... Horizontal 0 ~ 600° Vertical 0 ~ 300°
[ 12 ] ELECTROMAGNETIC COMPATIBILITY 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.
Guidance and manufacture’s declaration - electromagnetic emissions The SEARCHER70 DX-073 x-ray is intended for use in the electromagnetic environment specified below. The customer or the user of the SEARCHER70 DX-073 x-ray should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions The SEARCHER70 DX-073 x-ray uses RF energy only for its CISPR 11 internal function. Therefore, its RF emissions are very low and are Group 1 not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Harmonic emissions
Class A Class A
IEC 61000-3-2 Voltage fluctuations/ Flicker emissions IEC 61000-3-3
The SEARCHER70 DX-073 x-ray is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and manufacture’s declaration - electromagnetic immunity SEARCHER70 DX-073 x-ray is intended for use in the electromagnetic environment specified below. The customer or the user
of the SEARCHER70 DX-073 x-ray should assure that it is used in such an environment. IEC 60601 Immunity test Compliance level Electromagnetic environment - guidance test level Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic file. discharge (ESD) ±8 kV air ±8 kV air If floors are covered with synthetic material, the IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge
IEC 61000-4-5 Voltage dips, short interruptions and
voltage variations on power supply input lines IEC 61000-4-11
±2 kV for power
±2 kV for power
±2 kV common mode <5% UT (>95% dip in UT)
±2 kV common mode <5% UT (>95% dip in UT)
supply lines ±1 kV for input/output lines ±1 kV differential mode
for 0.5 cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT) for 25cycle <5% UT
Power frequency (50/60 Hz) magnetic field
(>95% dip in UT) for 5 s 3 A/m
supply lines ±1 kV for input/output lines ±1 kV differential mode
for 0.5 cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT)
relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the
user of the SEARCHER70 DX-073 x-ray requires continued operation during power mains interruptions, it is recommended that the SEARCHER70 DX-073 x-ray be powered from an uninterruptible power supply or a battery.
for 25cycle <5% UT
(>95% dip in UT) for 5 s 0.3 A/m
IEC 61000-4-8 NOTE UT is the a.c. mains voltage prior to applications of the test level.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Guidance and manufacture’s declaration – electromagnetic immunity
Revised for Page 11
The SEARCHER70 DX-073 x-ray is intended for use in the electromagnetic environment specified below. The customer or the user of the SEARCHER70 DX-073 x-ray 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 SEARCHER70 DX-073 x-ray, including cables, than
the recommended separation distance calculated from the equation applications to the Frequency of the transmitter.
Radiated RF IEC 61000-4-3
3V/m 80 MHz to 2.5 GHz
150 kHz to 80 MHz outside ISM bandsa
Recommended separation distance d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by adsorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SEARCHER70 DX-073 x-ray is used exceeds the applicable RF compliance level above, the SEARCHER70 DX-073 x-ray should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SEARCHER70 DX-073 x-ray. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. Essential performance (purpose of IMMUNITY testing) Unless the exposure switch is pressed, x-ray is not exposed.
Recommended separation distances between Portable and mobile RF communications equipment and the SEARCHER70 DX-073 The SEARCHER70 DX-073 x-ray is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SEARCHER70 DX-073 x-ray can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SEARCHER70 DX-073 x-ray as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power m of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz W d = 1.2√P d = 2.3√P d = 1.2√P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2 These quidelines may not apply in all situations. Electromagnetic propagation is affected by adsorption and reflection from structures, objects and people.
Takara Belmont (UK) Ltd. Belmont House One St.Andrews Way,Bow, London E3 3PA U.K. Tel: (44)20 7515 0333 Fax:(44)20 7987 3596
TAKARA BELMONT CORPORATION 2-1-1, Higashishinsaibashi,Chuo-ku,Osaka, 542-0083, Japan TEL. : +81 6 6213-5945 TELEFAX : +81 6 6212-3680
Book No. 1A048QB0
Printed in Japan 2011-09 MA