Takara Belmont EX-2000_Installation X-Caliber CM EX-2000 Panoramic & Cephalometric X-Ray Installation Instructions

EX-2000

PANORAMIC &
Cephalometric X-RAY

INSTALLATION

INSTRUCTIOINS

REV. 02

INDEX

SECTION ONE : TECHNICAL DATA

1) ELECTRICAL AND RADIATION DATA ...............................................................

2) MAJOR PARTS IDENTIFICATION ........................................................................

3) PHYSICAL DIMENSIONS ......................................................................................

4) TUBEHEAD THERMAL CHARACTERISTICS ....................................................

SECTION TWO : PRE-INSTALLATION INSTRUCTIONS

1) CERTIFIED COMPONENT COMPATIBILITY ......................................................

2) SUPPORT REQUIREMENTS ..................................................................................

3) ELECTRICAL REQUIREMENTS ...........................................................................

4) LOCATION OF COMPONENTS ...........................................................................

SECTION THREE : INSTALLATION INSTRUCTIONS

1) INSTALLATION REQUIREMENTS .....................................................................

2) COLUMN/COUNTERWEIGHT ASSEMBLY .......................................................

3) ROTATION UNIT (INCL. HEAD & CASSETTE HOLDER) ASSEMBLY .........

4) CHINREST SUPPORT ASSEMBLY ......................................................................

5) CONNECTION OF WIRES ...................................................................................

6) CEPHALO ARM/CEPHALOSTAT ASS’Y (X-CALIBER CM ONLY) ................

SECTION FOUR : POST-INSTALLATION CALIBRATION

1) LINE VOLTAGE AND LINE VOLTAGE REGULATION ....................................

2) TUBE CURRENT ...................................................................................................

3) EXPOSURE TIME ..................................................................................................

4) X-RAY FIELD SIZE AND ALIGNMENT .............................................................

APPENDIX ONE : CERTIFICATION ..............................................................................20

10

10

11

14

15

15

16

17

18

18

19

4

6

7

8

9

9

9

APPENDIX TWO : LAYOUT & FUNCTION OF CONTROLS .....................................21

APPENDIX THREE : CIRCUIT DIAGRAM ...................................................................22

APPENDIX FOUR : PARTS LIST ....................................................................................23

CAUTION !

This manual provides information and instructions for the installation, assem-

bly, calibration and certication procedures for the “X-CALIBER” panoramic

x-ray.
The instructions contained in this book should be thoroughly read and under-

stood before attempting to install the “X-CALIBER” unit. After the installation

is completed, file this manual and refer back to it when performing periodic
maintenance.

- 4 -

SECTION ONE : TECHNICAL DATA

[1] ELECTRICAL AND RADIATION DATA

1. Maximum rated peak tube potential .............. 90 kVp

2 Rated peak tube potential ...............................

3 Rated tube current ...........................................

4 Rated line voltage ...........................................

5 Line voltage range ..........................................

6 Range of line voltage regulation .....................

7 Maximum rated line current ...........................

8 Exposure time .................................................

15 sec. at TMJ mode

0.3 - 3.2 sec. (15 steps) at cephalometric mode

9 Minimum ltration .........................................

10 Focal point measurement ..............................

11 S. I. D. ...........................................................

1650 mm at cephalometric mode

NOTE :

Effective focal spot size ................. 0.5 mm X 1.0 mm

60 - 90 kVp (5 kVp in 7 steps)

10 mA

120 VAC

110 - 130 VAC

1 - 3 %

10 A at 90 kVp, 10 mA

12 sec. at panoramic mode

2.6 mmAl

1.0 mm X 1.0 mm

490 mm at panoramic & TMJ mode

12 Duty cycle .....................................................

NOTE :

13. Leakage technique factor ..............................

NOTE :

14. Film size .......................................................

15. Magnication rate .........................................

16. Tomographic orbit Single axis, continuous rotation

17. Nominal roentgen output at the end of beam limiting device*

a. Panoramic mode: 2.3 R/12 sec.

b. TMJ mode : 2.9 R/15 sec.

NOTE :

The exposure time in panoramic mode is 12 sec., therefore, 3 min. interval

or “Non Use” period requires the user to wait before making another expo-

sure. Because of the 15 sec. exposure time in TMJ mode, 3.75 min. waiting

time must be allowed after each series of 2 exposures.

0.63 mA is maximum rated continuous current for 10 mA with a duty cycle of 1 : 15.

40% at 90 kVp, 10 mA

±

40% at 90 kVp, 10 mA

±

at the distance of 450 mm from focal spot

1:15 (refer to NOTE below)

90 kVp, 0.63 mA

6 inch X 12 inch

1.25

18. Half value layer*

a. Approx. 3.3 mmAl equiv. at 90 kVp

b. Approx. 2.4 mmAl equiv. at 60 kVp

19. Maximum deviation of tube potential and tube current*

a. Tube potential : the selected kVp

b. Tube current : 10 mA

*NOTE :

20. Timer accuracy : ±5 %

21. Measurement basis of technique factors

a. Peak tube potential

The potential difference across the x-ray tube during the conducting half cycle and results

in an accuracy tolerance of ±15 %, as stated below:

From 0 - 0.3 sec., kVp may vary +35/-45 %

b. Tube current

The average mA value during a complete power line cycle, results in an accuracy tolerance

of ±10 %, except as stated below:

From 0 - 0.09 sec., mA may vary +150/-100 %

Approx. variation may be realized to measurement instrumentation, manu-

facturing tolerances, age, installation variables and use history.

10 %

±

15 %

±

From 0.1 - 0.19 sec., mA may vary +100/- 75 %

From 0.2 - 0.3 sec., mA may vary + 35/- 45 %

c. Exposure time

Impulse time is directly related to power line frequency.

Exposure time applies from the beginning of rst conducting line impulse to the end of last

impulse, results in an accuracy tolerance of ±5 %.

- 5 -

- 6 -

[2] MAJOR PARTS IDENTIFICATION

9

3

4

7

6

2

5

1

8

10

14

20

22

12

13

11

17

16

18
19

15

24

23

21

25

27

34

26

33

32

31

29

28

30

35

36

ID No. DESCRIPTION ID No. DESCRIPTION
1 Column Assembly 19 Ear Holding Rod (TMJ)
2 Column 20 Holding Rod Adjuster Knob
3 Top Cover 21 X-ray Head Assembly
4 Wall Bracket 22 Exposure Switch
5 Counterweight 23 Power Supply Cable
6 Sliding Unit Assembly 24 Base Plate (Option)
7 Sliding Unit Body 25 Cephalostat Arm
8 Electro-Magnetic Lock Switch 26 Electro-Magnetic Lock Switch
9 Driving Unit Cover 27 Ear Holding Rod Adjuster Knob
10 Rotation Unit Assembly 28 Ear Holding Rod (Cephalo)
11 Reset Switch 29 Forehead
12 Cassette Holder Assembly 30 Cassette Holder
13 Shield Plate 31 Cassette Holder Knob
14 Cover for Controller 32 Cassette Position Lock
15 Chinrest Assembly 33 Cassette Position Scale
16 Chinrest 34 Cephalostat Assembly
17 Chinrest Adjuster Knob 35 Beam Limiting Device
18 Head Holding Rod (Panorama) 36 Rotation Lock

[3] PHYSICAL DIMENSIONS

17.1"

435

mm

55.5"

1,410

mm

59.1"

1,500

mm

91.3"

2,320

mm

37.0"~70.9"

940~1,800

mm

42.0"

1,066

mm

33.3"

846

mm

59.1"

1,500

mm

240˚

- 7 -

- 8 -

[4] TUBE HEAD THERMAL CHARACTERISTICS

0

0

1 2 3 4 5

100000

200000

300000

400000

500000

1. Tu b e h ou s i n g c oo l in g c u rv e

3. M ax i mum ra t in g c h ar t

2. A no d e t he r ma l c h ar a ct e ri s ti c s c u r ve

H E A T S T O R A G E I N H U

T U B E C U R R E N T I N m A

H E A T S T O R A G E I N H U

T I M E I N H O U R S

0.1

0.5 0.7

1 5 7 10

T I M E I N S E C O N D S

T I M E I N M I N U T E S

0

0 2 4 6 8 10

5000

10000

15000

20000

25000

30000

35000

0

5

10

15

20

25

70kV

80k

V

90k

V

100k

V

A. INTERVAL BETWEEN EACH EXPOSURE

The temperature inside of the tube head rises when an exposure is made.
The value of the heat generated is measured in Heat Units (HU), which is the prod­uct of tube potential, tube current and exposure time. Excessive heat may damage
the x-ray tube, high voltage generator or both.

B. DUTY CYCLE

To avoid the accumulation of excessive heat in an effort to prolong the tube head
life, a cool down interval of 3 min. at panoramic mode or 3.75 min. at TMJ mode
must be allowed between each exposure.

C. TUBE HEAD COOLING CURVE

SECTION TWO : PRE-INSTALLATION INSTRUCTIONS

[1] CERTIFIED COMPONENT COMPATIBILITY

[2] SUPPORT REQUIREMENTS

1) The X-CALIBER unit must be securely bolted to the oor with 3/8 inch diameter fasteners
appropriate to the oor construction (lag screw into concrete, etc.)

NOTE :

2) Upper bracket must be attached to wall studs with minimum of two 5/16 x 3 inch lag
screws. Pre-bore holes with a maximum 3/16 inch diameter.
If studs are not available at the appropriate installation point of if stud wall construction is
not used, a rigid structure capable of supporting 100 lbs. pull out must be provided.

NOTE :

3) Screw slots are oversized to allow for positioning/levelling. Appropriate washers must be
used on all fasteners.

IN GENERAL, MAJOR STRUCTURAL MODIFICATIONS ARE NOT RE­QUIRED. HOWEVER THE FLOOR ON WHICH THE X-CALIBER CM IS
PLACED SHOULD BE ABLE TO SUPPORT 600 lbs. DEAD LOAD.

DO NOT USE THIS UNIT WITHOUT CORRECT BRACING.

[3] ELECTRICAL REQUIREMENTS

1) POWER SUPPLY
The X-CALIBER panoramic x-ray will operate on a power supply of 120 + 10 VAC. A three wire
GROUNDED circuit, separately connected to the central distribution panel with an over current
protection device rate for 20 amperes. Recommended wire size is 12 AWG. But if the wire run

distance is to exceed 50 feet, 10 AWG is required. For wire run distance in excess of 75 feet, up­to 125 feet, 8 AWG is required. Line voltage regulation must exceed 3 % at 12.5 amps.

2) All connections, workmanship and materials used must comply with the national Electric Code
and local codes.

- 9 -

- 10 -

[4] LOCATION OF COMPONENTS

NOTE :

When determining the location for the X-CALIBER unit, the following radiation require­ments concerning operator’s positioning must be considered.
The operator must:

1. Have full view of the patient.

2. Have full view of the technique factors before the exposure begins.

3. Be a minimum of 6 feet away from the source of radiation.

4. Be out of line of the useful beam of radiation or be positioned behind a protective device with

x-ray protection equivalent of 1 mm of lead.

Considering the conditions above, determine the correct location for the installation of the X-CAL-

IBER unit.

STATE AND LOCAL REQUIREMENTS SUPERSEDE GUIDE LINES INDICATED

BELOW.

SECTION THREE : INSTALLATION INSTRUCTIONS

Within the installation and calibration procedures are inspection/test steps which the installer

must perform to insure that the installation meets the manufacturer’s specications. These
steps are identied as “TEST” steps on the following pages.

[1] INSTALLATION REQUIREMENTS

1) TOOLS

* Standard tool kit
* Metric allen keys
* Jeweler’s screw driver

2) INSTRUMENTS

* Digital multimeter with an accuracy of 1%, capable of measuring 150 VAC and 20

mA DC, and capable of indicating true RMS value within one second

(Fluke 8026B or equivalent)

* Voltage impulse counter, capable of registering 1 to 999 half wave primary voltage

impulses at a rate of 60 per second over a range of 90 to 100 Vrms 60 Hz

[2] COLUMN/COUNTERWEIGHT ASSEMBLY

Column

Bottom Cover

Sliding Unit

Rear-side Cover

Sliding Unit

Column

Steel Rod

Lower Hole

Upper Hole

Covers

Counter Weight Frame

Column

1) Lay the column face up as shown, sup-

porting it with approximately 6" of lumber

covered with cloth, at the top end.

Put the bottom cover over the column and

slide it down all the way to the bottom of

the column.

2) Remove rear-side cover plates of sliding

unit by loosening three screws on each

plate, then slide the sliding unit over the

column and move it downward.

3) Turn the column face down as shown.

Insert the steel rod (provided) into lower

hole on column sides.

NOTE:

There are two pairs of holes on

the column sides. At this point, steel rod

should be inserted lower holes.

Remove rear cover of column.

4) Rem ove two covers of counterw eight

frame, and insert the counterweight frame

into column half the way.

- 11 -

- 12 -

5) Attach wire cable to the top of counterweight frame with two blocks as shown.

Wire Cable

Wire Cable

Counter Weight Frame

Counter Weight Frame

Blocks

Blocks



Cover

Adjusting Weight

Counter Weight

Steel Rod

Counter Weight

Frame

Cover

Adjusting Weight

Counter Weight

Steel Rod

Counter Weight

Frame

6) Push down the counterweight frame until it hits the steel rod, and set the counterweight

and adjusting weights in the upper box of the frame. Attach one cover of counterweight

frame.

7) Pull up the counterweight frame by pulling wire cable so that lower box of the counter-

weight frame meets the cutout on the column.

Set the counterweight and adjusting weights in lower box of the frame. Attach the other

cover of counterweight frame.

8) Pull out the steel rod from lower holes and insert it into upper holes.

Push down the counterweight frame until it hit the rod.

9) Attach wall bracket on top of the column.

Column

Wall Bracket

Pulley Assembly

Rear Cover

Sliding Unit

Column

Rear Side Cover

10) Attach pulley assembly on top of the column, and pass the wire cable of counterweight

over the pulleys.

11) Slide down the sliding unit until wire cables are fully extended.

12) Attach rear cover of column and two rear side cover plates of sliding unit.

13) Erect the column and mount it on the oor.

- 13 -

- 14 -

[3] ROTATION UNIT ASSEMBLY

Hook

Sliding
Unit

Rotation Unit

Carriage Holder

Sliding Unit

Electrical Connector

Bolt

Taper Pins

Rotation Unit

Carriage Holder

Rotation Unit Ass'y

1) By holding carriage holders with two

men, hook the rotation unit ass’y onto

the sliding unit.

NOTE:

To make this job easier, it is

recommended to pull down the sliding

unit, and reinsert the steel rod into up-

per hole so that counter weight frame

rests on the steel rod (sliding unit stays

at lower position).

2) Pull out the electrical connectors from

the sliding unit, and lead cable through

the hole on rotation unit body.

3) Insert taper pins with a hammer.

NOTE:

When knocking taper pins, be

sure the nut on each pin is fully loos-

ened.

4) Take the carriage holders off the rota-

tion unit assembly.

[4] CHINREST ASSEMBLY

Chinrest Ass'y

Connector

Wire

Slot

Chinrest Ass'y

Chinrest

Head Holding Rod
(for PANORAMA)

Head Holding Rod
(for T.M.J.)

Bite Piece

Connector

Top Cover

1) Connect cables from the sliding unit with

the cable in chinrest assembly by connec-

tors.

2) While pulling the wires through front lower

slot, attach chinrest ass’y to the sliding unit.

Insert the wires into the slot.

3) Install the chinrest in place.

[5] CONNECTION OF WIRES

1) Electromagnetic lock

Place the top cover of column, then connect cable to
the connecter at top rear of column.

2) In rotation unit

Cables from sliding unit must be connected as fol­lows;

(a) C o nnecto rs “C N 16”, “ CN17” , “CN24 ” and

“CNX2” should be connected to corresponding

terminals on CN Board B.

(b) Connector “CNL”, “CNB”, “CNb1” and “CNb2”

are to be connected to the connectors of same I.D..

- 15 -

- 16 -

[6] CEPHALO ARM/CEPHALOSTAT ASSEMBLY

Cephalo Arm

Set Screws

Screws

Supporting Rod

Cassette Holder

Screws

Cephalo Arm

Taper Pin

CNb1

1) Cephalo arm

(a) Attach the cephalo arm to the side

of sliding unit with three screws
[Do not fully Tighten].

(b) Insert two taper pins (w/nut).

(c) Tighten three screws rmly.

(d) Connect cables by connectors

CNb1.

2) Cephalostat assembly

(a) Insert two supporting rods of

ceph alo s tat in t o t he hole s of
cephalo arm from underneath as

far as they go, then x them with

four set screws.

(b) Attach cassette holder with two

screws.

SECTION FOUR : POST-INSTALLATION CALIBRATION

SW 3

TE ST CE

SHE E T S W.

CPU B OAR D

O

F

F

 VN ( ) - VL ( )
R = = x 100 = %
 VL ( )

No-load line voltage VN [VAC] = (VAC) 

Loaded line voltage VL [VAC] = (VAC) 

Calculation of line voltage regulation : R = (VN - VL) √ VL x 100



1

2

1 2

2

3

[1] LINE VOLTAGE AND LINE VOLTAGE REGULATION

1. Make sure the main power switch is OFF.
Remove the top cover of the driving unit.

2. Select a range in excess of 150 VAC of multimeter. Connect
probes of the meter to the terminal L1 and L2 of the connector

marked CN L on the CN BOARD C. (See gure right)

3. Set switch marked “TEST” of the Dip SW3, which is located

on CPU BOARD, to ON position.

4. Turn ON the main power switch.

5. Select 90 kVp and depress the ready switch on the control
panel.

6. Record the no-load line voltage (VN), indicated by the multi­meter before exposure, into line (1) below.

7. Make an exposure and record the loaded line voltage (VL)
indicated by the multimeter during exposure into the line (2)
below.

8. Calculate line voltage regulation (R) in % by substituting VN
and VL values in the formula below. [Insert in item (3) below.]

R = (VN - VL) ÷ VL x 100

NOTE:

LINE REGULATION MUST NOT EXCEED 3%. IF

IT IS GREATER THAN 3%, THE SIZE OF POWER
SUPPLY WIRES MUST BE INCREASED. REFER
TO THE POWER SUPPLY REQUIREMENTS OUT­LINED ON PAGE 7 TO DETERMINE THE COR­RECT WIRE SIZE.

9. Set the switch marked “TEST” of the Dip SW3 to OFF posi­tion.

10. Put the driving unit cover back on.

[INSERT VALUE BELOW ]

- 17 -

- 18 -

[2] TUBE CURRENT

SW 3

TE S T ��CE

SHEE T S W.

CPU B O A R D

CP+

CPI

JPI

CP-

OFF

Se t ti n g s  0.3  0. 5  0. 8  3. 2  un i t: s e c o n d 


Li m it  18 ±2  30 ±2  48 ±3  19 2 ± 5  un i t: p u l s e

1. Make sure the main power switch is OFF.

2. Select a range in excess of 20 mA DC of multimeter. Connect

probes of the meter to the check points CP+ and CP- of the CPU
BOARD. Set JP1 switch to the OFF position.

3. Set the switch marked “TEST” of the Dip SW3, which is located

on the CPU BOARD, to ON position.

4. Turn ON the main power switch.

5. Select 75 kVp and depress the ready switch on the control panel.

6. Point the x-ray head away from all personnel.

7. Make an exposure and record a mA indication on the multimeter

during exposure.

NOTE:

8. Select 90 kVp and make an exposure and record the reading again.

9. Select 60 kVp and make an exposure and record the reading again.

10. Make sure all readings are within the range of 10 ±1 mA DC.

11. Set the switch marked “TEST” of the Dip SW3 to OFF position,

and set JP1 to ON position.

12. Put the cover for the controller back on.

ALLOW 3 MINUTES COOLING TIME BETWEEN

EXPOSURES.

[3] EXPOSURE TIME

1. Make sure the main power switch is OFF. Remove the top cover of the rotation unit.

2. Connect probes of the voltage impulse counter to the check point CP T1 and CP T2 of the

POWER BOARD.

3. Turn ON the main power switch.

4. Depress the reset switch.

5. Select 75 kVp and depress the ready switch on control panel.

6. Make an exposure at panoramic mode, allowing the rotation unit to cycle fully to auto

stop position.

7. Make sure the registered reading is within the range of 720 ±36 impulses.

NOTE:

8. Repeat the procedures 4 thru 6 at TMJ mode.

9. Make sure the registered reading is within the range of 900 ±45 impulses.

NOTE:

10. Depress the Cephalometric mode switch, select 75 kVp and make exposures at 0.3sec.,

0.5sec., 0.8sec., and 3.2sec..

11. Read the reading of the voltage impulse counter and make sure the reading are within the

ALLOW 3 MINUTES COOLING TIME BETWEEN EXPOSURES.

ALLOW 3.75 MINUTES COOLING TIME BEFORE NEXT STEP.

following limits.

12. Put the top cover of the rotation unit back on.

[4] X-RAY FIELD SIZE AND ALIGNMENT

A. Panoramic mode

1. Set the panoramic cassette onto the panoramic cassette holder.

NOTE:

2. Turn the Main power switch ON and depress the Reset switch.

3. Select 60 kVp and depress the cephalo switch on the control panel to select the exposure

time of 0.3 Sec.

4. Depress the ready switch and make an exposure of 0.3 sec.

5. Develop the lm.

6. Make sure that the radiation eld dose not extend beyond any edge of the slit of the

shield plate and the dimension is not greater than 15 x 150 mm.

B. Cephalometric mode

7. Set the cephalometric cassette onto the cephalo cassette holder.

NOTE:

8. Engage the Rotation lock to secure the Rotation unit in cephalometric position.

9. Depress the ready switch and make an exposure of 0.3 sec. at 60 kVp.

10. Develop the lm.

11. Make sure that the radiation eld dose not extend beyond any edge of the lm.

T-MAT G FILM SHOULD BE LOADED.

T-MAT G FILM SHOULD BE LOADED.

- 19 -

- 20 -

APPENDIX ONE : CERTIFICATION

FOR FDA USE ONLY

a. NAME OF HOSPITAL, DOCTOR OR OFFICE WHERE INSTALLED

a. THIS REPORT IS FOR ASSEMBLY OF CERTIFIED COMPONENTS WHICH ARE(Check appropriate box(es))

b. INTENDED USE(S)(Check applicable box(es))

c. THE X-RAY SYSTEM IS (Check one) d. THE MASTER CONTROL IS IN ROOM

e. DATE OF ASSEMBLY

(mo.) (day) (yr.)

STATIONARY

MOBILE

a. THE MASTER CONTROL IS

f. SELECTED COMPONENTS

f.

(Enter number of each installed in appropriate blocks)

b. CONTROL MANUFACTURER

c. CONTROL MODEL NUMBER

a. PRINTED NAME b. SIGNATURE c. DATE

d. COMMENTS

Complete the following information for the certified components listed below which you installed. For beam limited device, tables and CT gantries the manufacturer and Model number in the
indicated spaces. For other certified components, enter in the appropriate block how many of each you installed in this system.

b. CONTROL SERIAL NUMBER

OTHER CERTIFIED COMPONENTS

X-RAY CONTROL

HIGH VOLTAGE GENERATOR

VERTICAL CASSETTE HOLDER

TUBE HOUSING ASSEMBLY

(Medical)

DENTAL TUBE HEAD

DATE MANUFACTURED

DATE MANUFACTURED

DATE MANUFACTURED

DATE MANUFACTURED

DATE MANUFACTURED

MODEL NUMBER

MODEL NUMBER

MODEL NUMBER

MODEL NUMBER

MODEL NUMBER

MANUFACTURER

MANUFACTURER

BEAM

LIMITING

DEVICE

TABLES

CT

GANTRY

MANUFACTURER

MANUFACTURER

MANUFACTURER

CRADLE

FILM CHANGER

IMAGE INTENSIFIER

SPOT FILM DEVICE

OTHER (Specify)

c. SYSTEM MODEL NAME (CT Systems Only)

A NEW INSTALLATION

EXISTING (Certified)

EXISTING (Non-certified)

ANGIOGRAPY

TOMOGRAPHY (Other than CT)

GENERAL PURPOSE FLUOROSCOPY

GENERAL PURPOSE RADIOGRAPHY

CHEST

CHIROPRACTIC

MAMMOGRAPHY

UROLOGY

PODIATRY

DENTAL - INTRAORAL

DENTAL - CEPHALOMETRIC

HEAD - NECK (Medical)

REASSEMBLY - MIXED SYSTEM (Both certified and uncertified components)

REASSEMBLY - FULLY CERTIFIED SYSTEM

NEW ASSEMBLY - FULLY CERTIFIED SYSTEM

AN ADDITION TO AN EXISTING SYSTEM

REPLACEMENT COMPONENTS IN AN EXISTING SYSTEM

CT WHOLE BODY SCANNER

CT HEAD SCANNER

DIGITAL

OTHER (Specify in comments)

C - ARM FLUOROSCOPIC

RADIATION THERAPY SIMULATOR

DENTAL PANORAMIC

b. STREET ADDRESS

c. CITY d. STATE

e. ZIP CODE

a. COMPANY NAME

b. STREET ADDRESS

c. CITY

e. ZIP CODEf. TELEPHONE NUMBER

d. STATE

From Approved: OMB No. 0910-0213
Expiration Date: December 31, 1992

See reverse for OMB statement.

D

XXXXXX

f. TELEPHONE NUMBER

1. EQUIPMENT LOCATION

3. GENERAL INFORMATION

4. COMPONENT INFORMATION

(If additional space is needed for this section use another form, replacing the preprinted number

 Number and complete items 1,4, and 5 only)

5. ASSEMBLER CERTIFICATION

FORM FDA 2579(7/92)

PREVIOUS EDITION IS OBSOLETE

White Copy - FDA, HFX490 , 5600 Fishers :Lace, Rockville, MD 20857

2. ASSEMBLER INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

REPORT OF ASSEMBLY

OF A DIAGNOSTIC X-RAY SYSTEM

FOOD AND DRUG ADMINISTRATION

I affirm that all certified components assembled or installed by me for which this report is being made, were adjusted and tested by me according to the instructions provided by the
manufacturer(s), were of the type required by the diagnostic x-ray performance standard (21 CFR Part 1020), were not modified to adversely affect performance, and were installed in
accordance with provisions of 21 CFR Part 1020. I also affirm that all instruction manuals and other information required by 21 CFR Part 1020 for this assembly have been furnished to the
purchaser and within 15 days from the date of assembly, each copy of this report will be distributed as indicated at the bottom of each copy.

1

1

Belmont Equipment Corp.

Location of Control Box

Belmont Equipment

X-Caliber-C

X-Caliber CM-B

APPENDIX TWO : LAYOUT & FUNCTION OF CONTROLS

2

1

6

8 3 4

5

7

9

CE

DN

UP

DN

UP

RESET

READY

OFF

ON

POWER

EXP OSURE

TMJ

INDICATOR

seckV

WA RN I N G

THIS X-RAY UNIT MAY BE
DANGEROUS TO PATIENT AND OPERATOR UNLESS
SAFE EXPOSURE FACTORS AN D OPE RATING
IN ST RUC TIO N ARE O BS ERV ED

BELMONT

10 mA

LAYOUT OF CONTROLS

(1) MAIN POWER “ON” AND “OFF” SWITCHES

Depressing POWER “ON” switch will turn the main power ON.

NOTE:

Indicators show standard conditions of 75 kVp and 12 Sec. when the main power is

turned ON.

(2) kVp “UP” & “DOWN” SWITCHES

Tube potential can be adjusted by depressing “UP” or “DN (Down)” switch between 60 and

90 kVp by 5 kVp increment or decrement.

(3) RESET SWITCH

Depressing this switch moves x-ray head assembly and cassette holder to the starting posi­tion for panoramic or TMJ radiography.

NOTE:

The switch located on the rotation arm has the same function. Refer to page 4, I.D.

No.11.

(4) READY SWITCH

Depress this switch after all the radiographing conditions are set, lm cassette is mounted

and patient is properly positioned.

An exposure can be made after the indicator lamp ashes three times and stays lit.
READY switch should be activated again after rst exposure of TMJ radiography.

NOTE 1:

READY switch turns ON only when the x-ray head assembly and the cassette
holder are at starting position.

NOTE 2:

Ready status will be cancelled unless an exposure starts within 15 seconds. (If you

are making an exposure after 15 seconds, depress READY switch again.)

NOTE 3:

READY switch will not function for 15 seconds after the main power switch is
turned ON.

(5) TMJ SWITCH

TMJ radiography can be made by depressing this switch.

(6) INDICATOR SWITCH

By depressing INDICATOR switch, fol­lowing three beam lines are available for
50 seconds.

1) Median Line

2) Frankfort Line

3) Focal Trough Line

(7) EXPOSURE INDICATOR

This lamp will remain illuminated while
x-ray is being generated.

(8) CEPHALOMETRIC SWITCH (MODEL

X-CALIBER CM ONLY)
By depressing this switch, cephalometric
mode can be selected.

(9) SEC. “UP” & “DN” SWITCHES

Exposure time can be adjusted by de-

pressing “UP” or “DN” switch.

- 21 -

- 22 -

P

S P11

1

1

5

S

P

1 2

21

CNTH(2P)

(2P)

(2P)

S

P

S

P

S

P

S

P

PA

CE

SW

S

S

P

1

1

S

P

1

1

S

P

S

P

S

P

(0.3mm

2

)

STYLE1638 X 2

STYLE1007 x 4

CIRCUIT :818-41272

PCB :308-02093

ASSY :408-05230-03

4

5

5

5

5

9

4

9

9

4

9

5

5

7

ASSY:408-06037

PCB:308-02039

CIRCUIT:818-41271

CIRCUIT:818-31256

PCB:308-02097

ASSY:408-05236-02

CIRCUIT:818-31256

PCB:308-02097

ASSY:408-05236-02

CIRCUIT:818-41258

PCB:308-02255

ASSY:408-05847

CIRCUIT:818-41258

PCB:308-02255

ASSY:408-05847

CIRCUIT:818-21255

PCB:208-01730

ASSY:408-05885

CIRCUIT:818-31254

PCB:308-02267

5

7

4

4

(0.3mm

2

)

(0.5mm

2

)

(0.5mm

2

)

(1.25mm

2

)

(1.25mm

2

)

STYLE1638 X 2

(0.3mmm

2

)

STYLE1638 X 2

(0.3mm

2

)

STYLE1638 X 6

4

4

2

4

4 4

BOARD

3

2

10

3

2

2

1

44

4

4

2

6

S

P

321

321

(3P)

CNS1

2 2

2 2

P

1

S

CNK2

(2P)

1

P

1

S

(2P)

CNK1

1

7

5

SW

K-BR

14

13

4

4

STYLE1638 X 2

12V

5

5

(6P)

99

7

BOARD

7

CN BOARD B

7

7

5

7

555

5

4

4

4

4

4

2

(2P)

CNL4

(4P)

(2P)

CNL2

(3P)

CNL1

2

4

2

10

R2

STYLE1007

(1.25mm

2

)

STYLE1007

(1.25mm

2

)

STYLE1007

(1.25mm

2

)

9

1

5

2

1

2

1

CNB

K-BR

POWER ON SW

K-OF

14

13

POWER OFF

1.5kVA

230V 50Hz

POWER SUPPLY

GN/YW

GN/YW

GN/YW

GN/YW

76J

432

1

432

1

BNBLGN/YW

13A

PLUG

K-L1

14

13

CNL3

N

L

ENL

NF

LINE SW

250V,8A

CN16

CN16

CN27

CN27

200J

2

1

2

1

+

-

BRAKE

D1

H05VV-F

STYLE1007

CN16, 2

CN16, 1

CN17, 2

CN17, 1

CNX, 1

CNX, 2

CPU BOARD

ORGRBK

GY

LAMP

LAMP

LAMP

INCISOR

MEDIAN

FRANKFURT

CN6, 1

CN6, 2

CN21, 1

CN21, 3

CN21, 4

CN21, 5

CNX, 1

CNX, 2

CN6, 1

CN6, 2

CN21, 1

CN21, 3

CN21, 4

CN21, 5

CNX, 1

CNX, 2

CN6, 1

CN6, 2

CN21, 1

CN21, 3

CN21, 4

CN21, 5

CNX, 1

CNX, 2

CN6, 1

CN6, 2

CN21, 1

CN21, 3

CN21, 4

CN21, 5

CNX, 1

CNX, 2

CN6, 1

CN6, 2

CN21, 1

CN21, 3

CN21, 4

CN21, 5

CN6, 1

CN6, 2

CN21, 1

CN21, 3

CN21, 4

CN21, 5

HOUSING

X-RAY TUBE

NE

NC0C

T2

T1

818-41269

(0.75mm

2

)

2

2

CNl,3,4

CNl,1,2

CNL,3,4

CNL,1,2

CNT,1
CNT,2

CNI,1
CNI,2

CNB,1

CNB,2

CNL,2

CNL,1

(1.25mm

2

)

(0.3mm

2

)

2

1

250V,8A

STYLE1638 x 2

(1.25mm

2

)

E

(1mm

2

)

G

N

L

PULSE MOTOR

974-00048

AUTO TRANS

PTC BOARD

POWER BOARD

MOTOR

ARM

CN BOARD B

27J

CNH

2 

CN10, 1

CN10, 4

CN10, 2

R1

80 X 2

R3

(40W)

20 

CN10, 3

CN19, 1

CN19, 3

CN19, 2

CN27, 1

CN27, 2

SW

RESET

REMOTE

DETECTOR

POSITION

START

PA CASSETTE

DETECTOR

POSITION

START

ARM

DETECTOR

POSITION

START

EXP

MOTOR

CASSETE

CNJ

CN70J

CN72J

CN74J

CN76J

CN78J

CN70J

CN72J

CN74J

CN76J

CN78J

ASSY:408-05844

PULSE MOTOR

7

CN3

GOVGO

V

GOV

CNZ 6

CNZ 5

CNZ 4

24P

0P

12M

0M

6L

0L

78J

0J

32F

0F

16D

0D

8C

0C

4B

0B

2A

0A

3J

220J

180J

0U

15U

33S

0S

14T

0T

0R

18R

70Q

35Q

0Q

CN35, 1

CN35, 2

CN35, 3

CN18, 1

CN18, 2

CN14, 1

CN14, 2

CN33, 1

CN33, 2

CN15, 1

CN15, 2

CND, 1

CND, 2

CN35, 1

CN35, 2

CN35, 3

CN18, 1

CN18, 2

CN14, 1

CN14, 2

CN33, 1

CN33, 2

CN15, 1

CN15, 2

CND, 1

CND, 2

CN35, 1

CNF, 1

CNF, 2

CNE, 1

CNE, 2

CN35, 2

CN35, 3

CN18, 1

CN18, 2

CN14, 1

CN14, 2

CN33, 1

CN33, 2

CN15, 1

CN15, 2

CNJ, 2

CNJ, 1

CNK2, 3

CNK2, 2

CNK2, 1

CNV2, 3

CNV2, 2

CNV2, 5

CNV2, 4

CNR3, 1

CNR3, 2

CNR2, 1

CNR2, 2

CNR1, 1

CNS, 6

CNS, 5

CNS, 4

CNS, 3

CNS, 2

CNS, 1

CNR1, 2

CNV1, 3

CNV1, 2

CNV1, 5

CNV1, 4

CNN, 6

CNN, 5

CNN, 4

CNA

CNV1, 1

CNK1, 3

CNK1, 2

CNK1, 1

CNJ, 3

CNJ, 4

CNZ 1

2

CN9

CN23, 1

CN23, 3

CN23, 4

CN23, 5

CN20, 1

CN20, 2

CN20, 3

CN20, 4

CN20, 5

CN20, 6

CN20, 7

CN20, 8

CN20, 9

CN20, 10

BLRDWHYWBRVYBKGYOR

GR

CN9

CN23, 1

CN23, 3

CN23, 4

CN23, 5

964-00008

SHEET SWITCH

CN20, 1

CN20, 2

CN20, 3

CN20, 4

CN20, 5

CN20, 6

CN20, 7

CN20, 8

CN20, 9

CN20, 10

BLRDWHYWBR

VY

CN24, 1

CN24, 2

CN24, 1

CN24, 2

12

(40W)

(40W)

CNB, 2

CNB, 1

CNB, 2

CNB, 1

CNB, 2

CNB, 1

CNB, 2

CNB, 1

CNI, 2

CNI, 1

CNI, 2

CNI, 1

CNB

70J

72J

74J

(1.25mm2)

CN BOARD C

S

ISOLATION CIRCUIT

LIVE CIRCUIT

SW3

P

S

P

S

PSP

S 4

4

1 2 3 4 1 2

214321

21321

21321

S

P

33

P

2

1

P

2

1

S

2

1

S

2

1

P

2

1

S

GN/YW

230V

T 1

SW5

CNZ 3CNZ 1 (4P)

CNZ 4

SW6

961-00020-54

OHD3-55B

THERMAI GUARD

CNZ 2 (4P)

SW2

SW1

SW4

2

1

2

1

9

K-L1

1

9

K-OFF

8

12

K-L1

SW

EXP

2

1

2

1

CNX

2

1

2

1

212

1

2

1

12345

6

12345

6

2

1

BRAKESWBRAKE

CN b

CN b 1CN b 3

CN b 2

ISOLATION CIRCUIT

LIVE CIRCUIT

(0.75mm2)

(0.75mm2)

(0.75mm2)

(0.75mm2)

(1.25mm2)

(1.25mm2)

APPENDIX THREE : CIRCUIT DIAGRAM

APPENDIX FOUR : PARTS LIST

- 23 -

- 24 -

X-Caliber Major Components and Parts

- 25 -

NOTE

BELMONT EQUIPMENT CORP.

101 Belmont Drive Somerset, New Jersey 08873 U.S.A.

TEL.:[phone] Fax.:[phone]

TAKARA CO, CANADA LTD.

2076 S. Sheridan Way, Mississauga, Ont., L5J2M4, Can.

TEL.:[phone] Fax.:[phone]

Printed in Japan 0603 MA