Advantech R-72, 32-A User manual

ADVANTECH, INC.

MODEL R-72/32-A

MANUALLY OPERATED

X-RAY COLLIMATOR

ADVANTECH, INC.

45945 TREFOIL LN. SUITE 112

STERLING, VA 20166

PHONE# [phone]

FAX# [phone]

ADVANTECH,				INC.	MODEL	R72
Labels: .4							M 1
М) ВБЕРАКФ............ иене							N 1
O) END OF LIFE DISPOSAL. i							O—1
P) WARRANTY:				i iiianaceraaaa nana eraa ra cananaa P—1
Q) SAFETY/RESPONSIBILITY					KKK KP	KRK	Q—2
RFIGURES,DIAGRAMS, TABLES..............................							R—1
				LIST OF FIGURES AND DIAGRAMS
Diagram		1	-Electronic	Timer Board	FM338		R—6
Diagram		2	-Electronic	Timer Board,	Eleciric		R—7
Diagram		3— Board layout 24V					R—8
Figure	1						R—I
Figure	2						R—2
Figure	3						R—3
Figure	4						R—4
Figure	5	- Parts Breakdown					R—5
Table 1 - MINIMUM FILTRATION REQUIREMENT — BEAM QUALITY (AVL)							H-]
Table 2		- Total Filtration of Primary			Beam in Aluminium Equivalence		H-2

INSTRUCTIONS MANUAL MTR72/DHHS - page iiii

ADVANTECH, INC.

MODEL R72

A) WARNINGS

| TO THE USER OF THIS MANUAL

THE COLLIMATOR DESCRIBED HEREIN IS TO BE ISTALLED ON A GENERAL PURPOSE UNIT CONFORMING TO

CEE 93/42, IEC NORMS IEC 601-1, IEC

601-1-2,

IEC

601-1-3

AND

21

CFR SUB CHAPTER

J OF

THE

CODE OF

FEDERAL

REGULATIONS.

CONFORMITY IS ENSURED ONLY IF

THE

COLLIMATOR

IS

INSTALLED

AND

USED

AS

INDICATED

IN

THIS

MANUAL.

THE USER OF THIS MANUAL

IS

REQUIRED

TO

READ

AND

CAREFULLY

REVIEW

THE

INSTRUCTIONS

AND

CAUTIONS

CONTAINED HEREIN

EVEN

IF

THE

PERSON

IS

PERFECTLY

CONVERSANT

WITH

THE

INSTALLATION

OF X-RAY COLLIMATOR.

COLLIMATOR

INSTALLATION AND

SERVICE

IS TO BE

PERFORMED

BY

PERSONNEL

AUTHORISED

BY

THE

MANUFACTURER OF THE X-RAY

SYSTEM OR BY RALCO SRL.

ANY PERSON ASSEMBLING, REPAIRING OR

REPLACING

THE

COLLIMATOR

INTO

AN

X-RAY

SYSTEM

MUST

VERIFY

COMPLIANCE

WITH

SAFETY

STANDARDS

COVERING

ELECTROMEDICAL

EQUIPMENT

AND

PERFORMING

A

SERIES

OF

TESTS

INDICATING

COMPLIANCE

WITH

21 CFR SUB CHAPTER J

OF

THE

PERFORMANCE

STANDARDS.

RECORDING THE DATA OBTAINED BEFORE

RELEASING

THE

COLLIMATOR

FOR

USE IS REQUIRED,

SUCH

DATA

WILL

DEMOSTRATE

AT

LATER

TIME

THAT

ALL

TESTS

WERE

PERFORMED

AND

THE EQUIPMENT WAS LEFT IN FULL COMPLIANCE WITH THE STANDARDS.

PROPER INSTALLATION, OPERATION AND MAINTENANCE OF THE COLLIMATOR SHOULD EXCLUDE OPERATION

PROBLEMS

OF THE COLLIMATOR AND OF THE SURROUND

EQUIPMENT

SINCE

RALCO

HAS

SUCCESSFULLY

PASSED

EMC

TESTING.

THE

USEFUL

X-RAYS

AND

SCATTERED

RADIATION

ARE

DANGEROUS

TO

BOTH

OPERATOR

AND

OTHERS

IN

THE VICINITY UNLESS ESTABLISHED SAFE EXPOSURE PROCEDURES ARE

STRICTLY

OBSERVED.

THOSE AUTHORISED TO OPERATE OR SERVICE THE EQUIPMENT MUST BE THOROUGHLY FAMILIAR WITH THE

PROCEDURES

REGARDING

RADIATION

PROTECTION..

FAILURE

TO

FOLLOW

THE

MANUFACTURER'S

INSTRUCTIONS,

OR

MODIFICATION

OF

ANY

COMPONENT

BY

USER OR ASSEMBLER WHICH WILL

AFFECT

RADIATION

SAFETY,

CAUSES THE

USER

OR

ASSEMBLER

TO

ASSUME

FULL

RESPONSIBILITY

FOR THAT

PRODUCT.

THE INSTRUCTIONS MANUAL SUPPLIES INDICATIONS ON STANDARD OPTIONAL MATERIAL. SPECIFIC DATA

REGARDING

THE

VERSION

PURCHASED

IS

PROVIDED

BY

THE

LABEL

OR

BY

ANNEXED DOCUMENTATION

THIS

DOCUMENT

WAS

TRANSLATED

FROM

THE

ITALIAN

VERSION,

ISSUED

AND

DISTRIBUTED

BY

RALCO SRL

MANUFACTURER

OF THE

X-RAY

COLLIMATOR DESCRIBED. ADDRESS ENQUIRIES

TO:

RALCO

SRL

VIA

SCHIAPPARELLI

27/33

20035

LISSONE

(MI)

-

ITALIA

FAX.

[phone]

- EMAIL:

[e-mail]

INSTRUCTIONS MANUAL MTR72/DHHS - page A—1

ADVANTECH, INC. MODEL R72

B) DESCRIPTION

External

cover

in ABS plastic.

Single-layer,

sguare

field

radiological

collimator.

Its light weight and compact size allow easy

positioning

and make

it ideal

for

mobile and

portable

units.

The X-ray field size

is

limited by

two

pairs

of

lead

shutters

controlled

by

two

knobs

located

on

the

sides

of

the collimator

and by

a

lead

disc

near

the

x-ray

focus

to

reduce

scattered radiation.

|

An indexed scale provides information on the field set with the knobs.

Specifications:

e

Adjustment

of mirror

angulation

may

be

performed by

removing

the

outside cover.

High luminosity

of

the

light

field

projected

by

a

quartz iodide

lamp.

e

Electronic

timer

that

limits

lamp-on

time

to 30

seconds

-

adjustable.

This

extends lamp

life and

prevents

overheating.

Radiation protection

up to

125 kVp

-4

mA

Inherent

filtration

minimum

2mm

aluminium

equivalent.

(1mm

on

request)

e

Continuous

film

coverage

from

0x0

cm

+

1%

to 43x43

cm

at

an

FFD

of

90cm.

INSTRUCTIONS MANUAL MTR72/DHHSpage B—1

ADVANTECH,

INC.

MODEL

R72

Model R72

is

a square field

X-ray

collimator

designed

and constructed

for

installation

on

all fixed anode x-ray tubes and rotating anode x-ray tube

that

when

mounted

with the

R72

maintain conformity

to EN60601-1-3

par.

29.202.3. By

means

of two knobs

placed

at

90°

one from

the

other,

stepless

adjustment

is

possible

of

the

X-ray

field

dimension

to

the

size of the image receptor or to that of the anatomical area of interest.

The X-ray beam		is	controlled by a lead	cone positioned on	the	entrance into	the
Collimator	body	and	by 2 pairs of lead faced	shutters positioned	at the	exit window of	the
x-ray beam	from	the	collimator.

D fuoco/focus

2!

o mM

Total focus/skin distance = 309,5 mm

The direct	visualisation	of the x-ray field	is	given by		a	light beam	which correspond to			the
x-ray beam, within a		tolerance of one	percent		of	the	selected	distance.	The	light-field
centre is	provided by	the intersection	of	two	perpendicular silk-screened				lines	into	the

Lexan window and projected on the light field by the light beam.

To activate the light field, press light-related

pushbutton

оп the

collimator.

The

light

will

switch on for 30 seconds (adjustable) and then automatically switch

off.

Average

illumination

at

1m is

minimum

160

Lux with a

100W,24V

(100w,

12V

optional)

quartz iodide

lamp;

edge

contrast ratio

is >3,2:1

The

field

size

at 90cm,

100cm

and 180

cm

Focus-Film

Distances

(FFD) (SID) is

read

on

the

collimator

panel.

INSTRUCTIONS MANUAL MTR72/DHHSpage B—2

ADVANTECH, INC. MODEL R72

C)

SPECIFICATIONS:

|

Rev.C |

e

Inherent

filtration

Al.

equivalent :

Min.

2.0

mm.

Al.

x-ray

beam

=

75

kV

EN 60601-1-3

par.

29.201.6

/ 29.201.7

e

Limitation

of

Extra

focal

radiation:

<

150

mm

focus

distance

80

mm

,

FFD

(SID)

100

cm

EN 60601-1-3

par.29.202.3

X-ray field selection

:

Min:

00

x

00

mm

(+

1%

D.F.F.)

100 cm

FFD

(SID)

Max.

480

x 480

mm

(+

1%

D.F.F.)

EN 60601-1-3

par.

29.202.4

e

Light

field

indicator:

>

160

Ix

luminosity

at

100

cm

from

the focus:

EN 60601-1-3

par.

29.202.7.

e

Light

field

indicator

:

>3:1

edge

contrast

setting

350x250

mm

at

1000

mm

FFD

EN 60601-1-3

par.

29.202.7

e

X-ray field indication

precision:

<

2

%

D.F.F.

settings

on

an

index

scale

EN 60601-1-3

par.

29.202.8

e

Light

field

indicator

precision :

<1%

D.F.F:

Light field/x-ray field

correspondence:

EN 60601-1-3

par.

29.202.9

e

FDD

(SID):

(optional)

<

2%

D.F.F.

Precision

of

measurement

with

retractable

tape

EN 60601-1-3

par.

29.203.2

e

Leakage

radiation:

<

50

mR/h

x-ray

beam

=

125

kVp

/4

mA

EN 60601-1-3

par.

29.204.3

e

Lamp

power

supply:

24V

DC/AC

Standard

lamp

24V

100

W

OSRAM

HLX

64638

|

50/60

Hz

6.5A

e

Fuse,

lamp

4

Amp

delayed

certified

e

Weight:

3.6

kg

Classification

EN 60601-1

par.

5

Protection

against

electric

hazards:

“Class

I? equipment

Protection against direct and indirect contacts: Type

B

equipment

with

applied

parts.

Protection

against

water

seepage

: “Common

equipment”

Safety

of

operation

in

the

presence

of

inflammable

anaesthetics

with

air

or

oxygen or

nitrous

oxide:

Equipment

not

suited

to

application

in

the

presence

of

inflammable

anaesthetic

mixtures

containing

air

o

oxygen

of

nitrous

oxide..

INSTRUCTIONS MANUAL MTR72/DHHSpage C—1

ADVANTECH,

INC.

MODEL

R72

e

Operation

conditions:

Equipment

for

continuous

operation

at

intermittent

loads

.-

See Operation Instructions on page |—1.

Should

label

data

on

the collimator

not

correspond to

the specifications

herein,

inform Ralco

of

the non

conformity.

Verifications of the specifications are to

be

performed

according to

the

Standards

relating

to

specified

eguipment.

Operation

environment:

e

Ambient temperature = from 10°C

to

40°C

e

Relative

Humidity

= from

30% to

75%

e

Atm.

Press. =

from

700

to

1060

hPa.

Included with the collimator :

e

Instructions

Manual

Retractable

measuring

tape

shows

the

Focus

Film

Distance (FFD -

SID).

e

ROOO2:

Set

of

three

mounting

spacers

1.5

mm

(0.05") thick, steel

(to increase focus-to-

collimator

fixing

plane

distance.

RO

181

-

Tube

port

mounting

fixed

flange,

10mm

thickness.

RO

198:

Focus/skin

spacer

to

keep

the

patient

at

30 cm.

Optional	item:
e RO	199 -	tube	port mounting		flange,		rotating +90°,	stop at 0°,	thickness 10mm.
Symbols
SIMBOLI/
SYMBOL				DESCRIZIONE /DESCRIPTION.						NO.	RIF.CE!
S
O	| Corrente		Alternata/Alternating				Current			01-14	417-IEC
											503
—	| Corrente		Continua/Direct			current				01-18	0
———	|Corente			continue	e	Alternata/Both		direct	and	01-19	417-1EC
	l'alternating			current							5033
		|		|
											417-IEC
D	Terra	di	protezione/protective				earth			01-20
											5019
	-		a	,			,			01-27	417-IEC
	Piu;	polarita		positiva/Plus;		positive polarity					5005
umas		|						polarity		01-28	417-IEC
	Meno; polarita negativa/					Minus; negative					5006

INSTRUCTIONS MANUAL MTR72/DHHSpage C—2

ADVANTECH,		INC.	MODEL R72
SIMBOLI/
SYMBOL		DESCRIZIONE /DESCRIPTION.	NO.	RIF.CEl
5
©)	Entrata/	Input	01-36	417-IEC
				5034
(>>	|Uscita/	Output	01-37 |	"5035
				417-IEC

| 7	Controllo	a distanza/Remote Control
SN	Controllo	manuale/Manual control

©Controllo automatico/ Automatic control (closed loop)

©)	Diaframma	a	iride	aperto/	Iris	diaphragm:open
	.	a	Lu	Le	,	diaphragm:	|	closed
	Diaframma		iride:	chiuso/	iris
	Attenzione,	consultare 1 documenti di

01-38	-
01-45	de”
01-46	160 7000
01-69	~
01-70	417-ЕС
	5324

VAN

accompagnamento/

03-02

|

IEC 601-1

Attention,

consult

accompanying

documents

23S

Filtro

di radiazione oppure

filtrazione

/

04-51

417-IEC

Y

Radiation

filter

or

filtration

|

5381

E.

Indicatore luminoso del campo di

radiazione/

04-54

|

41 MEC

Light indicator of the radiation field

5384

Dispositivo di limitazione fascio: aperto/

04-55

417-IEC

Beam

limiting

device:

open

5385

Dispositivo di limitazione fascio: chiuso

04-56

417-IEC

Beam

limiting

device:

closed

5386

Dispositivo

di

limitazione

fascio

con

apertura

separata

della

lamelle.

04-57

417-ЕС

|

Beam

limiting

device

with

separate

opening

of

the

5387

shutters

Dispositivo

di

limitazione

fascio

con

chiusura

separata

H

della

lamelle.

04-58

417-IEC

Beam

limiting

device

with

separate closing

of

the

5388

shutters

+

Apparecchio tipo

B/type B

unit

878-02-02

INSTRUCTIONS MANUAL MTR72/DHHSpage C—3

ADVANTECH, INC.

MODEL R72

SIMBOLI/ SYMBOL

DESCRIZIONE

/DESCRIPTION.

NO.

RIF.CEI

4 a x

\

| Attenzione

radiazione

Laser/Caution Laser

Radiation

60825-1

COMPATIBILITY WITH X-RAY TUBE HOUSING ASSEMBLIES:

Compatibility

is

determined

by

the ability

to

comply

mechanically

with

the

dimensional

drawing

on

Figure

1

page

R—1;

that

the

tube

housing

assembly

must

have

a

minimum

inherent

filtration

of

1

mm.

Al.

equivalent

and

a

maximum

radiation

leakage of

40

mr/hour

measured at

one

meter from

the

source

when

operating at

its

leakage

technique

factors

(125

kVp at 4

mA).

Source

values

(tube

housing-collimator)

must

not be

less

than 3mm Al

for

filtration

and

must never exceed 100 mR/hr for radiation leakage.

INSTRUCTIONS MANUAL MTR72/DHHSpage C—4

ADVANTECH, INC. |

MODEL R72

D) MOUNTING THE COLLIMATOR TO THE X-RAY TUBE:

|

WARNING

CAREFULLY

FOLLOW

THE

MOUNTING

INSTRUCTIONS

AND MAKE SURE THAT THE

COLLIMATOR

IS CORRECTLY

ASSEMBLED.

INCORRECT

MOUNTING

COULD

BE

DANGEROUS:

IT

COULD

CAUSE

THE COLLIMATOR

TO

FALL

OR

TO OPERATE

INACCURATELY

1.

Determine

the

distance

from

the

focal

spot

to

the

tube

port

face

from

the

x-ray

tube

or

generator

literature.

2.

Subtract

the

resulting

distance

from

70

mm

(2,75")

and

determine

how

many

1.5

mm

(0.05")

spacers

combined

with

the

thickness

of

the

mounting

flange

will

be

required

to

make

up

the

difference.

See Figure 4 on page R—4.

3.

The

outer

face

of

the

collimator

mounting

flange

must

be

at

70mm

from

the

focal

spot.

Allowable

tolerance

is 1

mm.

(0.039").

-

see

Figure

4

on

page

R—4

4.

Select

four

countersink

bolts of suitable thread (M6

)

and

of

such

a

length

that

they

protrude through

the

flange

and

spacers

far

enough

to

engage

at

least

5

threads

into

the

tube

port

face.

Securely

bolt

the flange to the tube port face.

5.

Remove

the

cover

by

unscrewing

the

four

M3

screws

located

on

the

lower

side

of

the

cover.

6.

Unscrew

the

four

mounting

and

centring

adjustment

Allen

screws

M6

until

the

four

tongues

are

withdrawn

from

the

collimator

top

opening;

see

Figure.

1

—

page

R—1.

Note:

when

unscrewing

the

Allen

screws

that

control

the

tabs

do

not

use

force

exceeding

0,55

Nm

7.

Place

the

collimator

on

the

flange.

Tighten

the

four

mounting

screws

equally

until

the

collimator

is

held

firmly

on

the flange

(0,55Nm

max),

see

Figure.

1

—

page

R—1.

Collimator

control

tabs

conform to EN 60601-1-par

28.4.

8.

Check

to

see

that

the distance

from

the

collimator

housing

to

the

mounting

flange

is

equal

in all

directions

and

that

the

collimator

face

is

parallel

to

the

axis

of

the table.

9. Repeat the alignment if necessary.

INSTRUCTIONS MANUAL MTR72/DHHSpage D—1

ADVANTECH, INC.

MODEL R72

E) ELECTRICAL POWER		CONNECTION:
CHECK ON THE COLLIMATOR LABEL THE VERSION				SUPPLIED.
		WARNING
COLLIMATOR SUPPLY IS NOT PROTECTED BY A					FUSE.			CHECK THAT THE
COLLIMATOR IS PROTECTED BY AN EXTERNAL FUSE					PRIOR TO			CONNECTION.
FUSE REQUIREMENTS:	4A	DELAYED	FOR	THE	24v	VERSION
	8A	DELAYED	FOR	THE	12V		VERSION
CABLES AND TERMINALS USED FOR THE INTERNAL CONNECTION						OF	THE	COLLIMATOR	MUST BE
SUITABLE FOR OPERATION AT TEMPERATURES OF 70°					C	AND		COLLIMATOR	CURRENT
ABSORPTION.

Collimator supply must conform to MDD 93/42

Power supply connection:

Unscrew the 4 screws on the lower portion of the cover; remove the cover.

Connect

the

the

cables

to the

terminal

board

contacts

+2Vcc (M3) and OV (M5)

e

Refer to

the timer

board

diagrams

on

pages

R—6,

R—7,

R—8.

|

Connect

the

earth

cable

to

the

appropriate

contact

on

the

terminal board marked

by the

symbol:

Remount

the

cover.

WARNING

INCORRECT POWER SUPPLY COULD DAMAGE THE ELECTRONIC TIMER AND/OR THE LAMP.

SUPPLY

TO

THE

QUARTZ

IODIDE

LAMP

AND

TIMER MAY

BE

EITHER IN ALTERNATE CURRENT OR

DIRECT

CURRENT

- IN

THE

LATTER CASE

MAKE

CERTAIN

THE

POLARITY IS RESPECTED.

INSTRUCTIONS MANUAL MTR72/DHHSpage E—2