MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
A
DVISORY
2
R22
1/A
- R221
/A DHHS -
Ad
visory
Ralco
srl
T
HE
COLLIMATOR
DESCRIBED
HERE
,
IS
USED
ON
R
ADIOLOGICAL
SYSTEMS
AND
IS
CLASSIFIED
AS
A
TYPE
IIB
ACCORDING
TO
A
TTACHMENT
IX. T
HE
COLLIMATOR
HAS
BEEN
DESIGNED
AND
MANUFACTURED
IN
COMPLIANCE
TO
A
TTACHMENT
II
OF
L
EGISLATIVE
D
ECREE
, 2 F
EBRUARY
1997, N. 46, I
MPLEMENTATION
OF
D
IRECTIVE
93/42/CEE
OF
14 J
UNE
1993
AND
SUCCESSIVE
MODIFICATIONS
APPLYING
D
IRECTIVE
2007/47/CE.
L
IST
A
PPLICABLE
S
TANDARDS
AND
TO
WHICH
R
ALCO
ADHERES
TO
:
EN 60601-1:2006
EN 60601-1-2:2007
EN 60601-1-3:2008
EN 60601-2-45:2012
EN 60601-2-54:2009
EN 60825-1:2007
ISO 9001:2008
UNI ESO 13485:2004
21 CFR
SUBCHAPTER
J (FDA)
8750 01 & 8750 81 (CSA)
CE
*R
ALCO
CAN
PROVIDE
DOCUMENTATION
REGARDING
ITS
ADHERENCE
TO
ANY
OF
THE
ABOVE
STANDARDS
.
EN 60601-1 par. 5
•
P
ROTECTION
AGAINST
ELECTRIC
HAZARDS
: "C
LASS
I"
EQUIPMENT
.
•
P
ROTECTION
AGAINST
DIRECT
AND
INDIRECT
CONTACTS
: T
YPE
B
EQUIPMENT
WITH
APPLIED
PARTS
.
•
P
ROTECTION
AGAINST
WATER
SEE
PAGE
: "C
OMMON
EQUIPMENT
".
•
S
AFETY
OF
OPERATION
IN
THE
PRESENCE
OF
INFLAMMABLE
ANAESTHETICS
WITH
AIR
OR
OXYGEN
OR
NITROUS
OXIDE
: E
QUIPMENT
NOT
SUITED
TO
APPLICATION
IN
THE
PRESENCE
OF
INFLAMMABLE
ANAESTHETIC
MIXTURES
CONTAINING
AIR
OR
OXYGEN
OR
NITROUS
OXIDE
.
•
O
PERATION
CONDITIONS
: E
QUIPMENT
FOR
CONTINUOUS
OPERATION
AT
INTERMITTENT
LOADS
- S
EE
C
HAPTER
O
PERATION
I
NSTRUCTIONS
.
•
S
HOULD
LABEL
DATA
ON
THE
COLLIMATOR
NOT
CORRESPOND
TO
THE
SPECIFICATIONS
HEREIN
,
INFORM
R
ALCO
OF
THE
NON
CONFORMITY
.
•
V
ERIFICATIONS
OF
THE
SPECIFICATIONS
ARE
TO
BE
PERFORMED
ACCORDING
TO
THE
INDICATED
EQUIPMENT
STANDARDS
.
I
NHERENT
D
ANGER
OF
X-R
AYS
T
HE
COLLIMATOR
HAS
BEEN
CONSTRUCTED
TO
CURRENT
STANDARDS
TO
MEET
THE
SAFETY
REQUISITES
OF
D
IRECTIVE
2007/47/CE
AND
ALL
OTHER
APPLICABLE
STANDARDS
. H
OWEVER
,
DUE
TO
R
ADIOLOGY
BEING
AN
INHERENT
DANGEROUS
ACTIVITY
WHICH
CANNOT
BE
COMPLETELY
SAFE
GUARDED
AGAINST
,
IT
IS
CRUCIAL
THAT
ALL
SAFETY
PROCEDURES
ARE
FOLLOWED
. T
HE
INSTALLER
AND
OPERATOR
MUST
FOLLOW
ALL
ESTABLISHED
PROCEDURES
(
INCLUDING
THOSE
MENTIONED
IN
THIS
MANUAL
)
TO
REDUCE
THE
INHERENT
DANGER
OF
X-R
AYS
.
T
HE
INHERENT
RISK
OF
USING
COLLIMATORS
IN
R
ADIOLOGICAL
SYSTEMS
IS
DEEMED
REASONABLE
AS
DETERMINED
BY
APPLICABLE
STANDARDS
. T
HE
USE
OF
COLLIMATORS
FOR
R
ADIOLOGICAL
SYSTEMS
IS
STRICTLY
REGULATED
.
R
ALCO
FOLLOWS
ALL
APPLICABLE
STANDARDS
. I
T
IS
UP
TO
THE
INSTALLER
AND
OPERATOR
TO
ENSURE
THAT
ALL
POSSIBLE
STEPS
ARE
FOLLOWED
TO
ENSURE
THE
HEALTH
AND
SAFETY
OF
THE
PATIENT
AND
OPERATOR
.
Содержание MTR 221/A
Страница 66: ...info_cl fm...
