MTR221/A - MTR221/A DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
Modello/Model R221/A - R221/A DHHS
ADVISORY
2
R221/A - R221/A DHHS - Advisory
Ralco srl
THE COLLIMATOR DESCRIBED HERE, IS USED ON RADIOLOGICAL SYSTEMS AND IS CLASSIFIED AS A TYPE IIB
ACCORDING TO ATTACHMENT IX. THE COLLIMATOR HAS BEEN DESIGNED AND MANUFACTURED IN COMPLIANCE
TO ATTACHMENT II OF LEGISLATIVE DECREE, 2 FEBRUARY 1997, N. 46, IMPLEMENTATION OF DIRECTIVE
93/42/CEE OF 14 JUNE 1993 AND SUCCESSIVE MODIFICATIONS APPLYING DIRECTIVE 2007/47/CE.
L
IST APPLICABLE STANDARDS AND TO WHICH RALCO 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
•PROTECTION AGAINST ELECTRIC HAZARDS: "CLASS I" EQUIPMENT.
•PROTECTION AGAINST DIRECT AND INDIRECT CONTACTS: TYPE B EQUIPMENT WITH APPLIED PARTS.
•PROTECTION AGAINST WATER SEE PAGE: "COMMON EQUIPMENT".
•S
AFETY 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 OR OXYGEN OR NITROUS OXIDE.
•O
PERATION CONDITIONS: EQUIPMENT FOR CONTINUOUS OPERATION AT INTERMITTENT LOADS - SEE CHAPTER
OPERATION INSTRUCTIONS.
•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 INDICATED
EQUIPMENT STANDARDS.
INHERENT DANGER OF X-RAYS
THE COLLIMATOR HAS BEEN CONSTRUCTED TO CURRENT STANDARDS TO MEET THE SAFETY REQUISITES OF
D
IRECTIVE 2007/47/CE AND ALL OTHER APPLICABLE STANDARDS. HOWEVER, DUE TO RADIOLOGY BEING AN
INHERENT DANGEROUS ACTIVITY WHICH CANNOT BE COMPLETELY SAFE GUARDED AGAINST, IT IS CRUCIAL THAT
ALL SAFETY PROCEDURES ARE FOLLOWED. THE INSTALLER AND OPERATOR MUST FOLLOW ALL ESTABLISHED
PROCEDURES (INCLUDING THOSE MENTIONED IN THIS MANUAL) TO REDUCE THE INHERENT DANGER OF X-RAYS.
THE INHERENT RISK OF USING COLLIMATORS IN RADIOLOGICAL SYSTEMS IS DEEMED REASONABLE AS DETERMINED
BY APPLICABLE STANDARDS. THE USE OF COLLIMATORS FOR RADIOLOGICAL SYSTEMS IS STRICTLY REGULATED.
R
ALCO FOLLOWS ALL APPLICABLE STANDARDS. IT 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.
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