Ralco R 221 ACS DHHS Series, Инструкция по эксплуатации

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MTR 221 ACS - MTR 221 ACS DHHS
MANUALE ISTRUZIONI / INSTRUCTION MANUAL
I
NTRODUCTION
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Model R 221 ACS - R 221 ACS DHHS
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INTRODUCTION
General Safety Information
Ralco products are designed and manufactured to meet the international safety standards for medical equipment.
However, all medical electrical equipment requires proper installation, operation and servicing, particularly with regard to
human safety.
Read, note, and strictly observe all safety tags on the equipment. Strictly observe all safety directions, all warnings and all
cautions that are mentioned in this chapter and throughout this service documentation. In order to protect the personal
health of service personnel, operators and patients, ensure the safe servicing and operation of the system.
Intended Use of the Collimator
This collimator is designed to be used with a Radiological system producing ionizing radiation for medical or veterinary
use. Whomever is authorized to operate or service the radiological equipment must be thoroughly familiar with the
procedures related to radiation protection and equipment use and maintenance.
Ralco is not responsible for any personal injuries or damage to property from misuse or unintended use of this collimator.
This manual must be made available to the installer and operator.
Installer and Operator Responsibility
The installer and operator must verify that ALL safety standards are followed immediately after installation of the
collimator and before any subsequent use. All procedures regarding the installation and safe use of this collimator must
be strictly followed.
X-ray equipment manufacturer responsibility
If the X-ray equipment manufacturer does not use the READY signal, allowing X-ray exposures regardless of collimator
state or status, all liability falls upon the X-ray equipment manufacturer. In the event of any emergency and the READY or
ERROR signals are bypassed allowing X-ray exposures, all the liability falls upon the X-ray equipment manufacturer.
The collimator electronics supplies a signal defined as READY. The X-ray equipment manufacturer will manage this
signal as the X-ray consent. In the event of a collimator failure, the liability for the correct bypass of this signal, in order to
always ensure the X-ray consent, devolves upon the X-ray equipment manufacturer.
Reporting
Information regarding accidents that have occurred while using this collimator must be reported immediately to Ralco, srl.
Limitation of Liability
Ralco is not liable if the provided instructions are not complied with. Furthermore, Ralco is not liable if one or several of
the following instances apply:
If the unit is specifically designed per client specifications and the certification was the duty of the client;
The collimator was modified in any way by the OEM or operator;
The collimator was installed without respecting the instructions, as provided in this manual;
The collimator was used in a way outside its intended use;
The collimator was not installed by competent personnel;
The collimator was not operated safely or in a way contrary to the instructions in this manual;
The collimator was not subject to routine inspection and maintenance by competent personnel;
The collimator was repaired with non-Ralco spare parts;
The Collimator was Used in a Way Not Reasonably Foreseen by Ralco
Ralco is not liable for any direct or indirect damage caused if the procedures in this manual are not followed.
The collimator complies with current standards for static load, a non-wearing class. This statement is based on
studies and tests performed on the collimator performance and its weight. If the final system, through tilting movements
or other dynamic movements, increases the risk factor other than those studied and tested, it is the responsibility of the
customer to ensure that there are no dangerous situations.
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.
List Applicable Standards and to which Ralco adheres to:
IEC 60601-1:2005 + Am1:2012 (ed. 3.1), North American market deflections (US+CA)
IEC 60601-1-2:2014 (ed 4)
IEC 60601-1-3:2008 + Am1:2013 (ed. 2.1)
IEC 60601-2-54:2009 + Am1:2015 (ed. 1.1)
IEC 60601-2-45:2011 + Am1:2015 (ed. 3.1) Applicable in Mammography instead of IEC 60601-2-54:2009
IEC 60601-1-6:2010 + Am1:2010 (ed. 3.1) (Usability)
IEC 62304:2006 + Am1:2015 (ed. 1.1) (Software)
IEC 60825-1:2014 (LASER - if applicable)
IEC 62471:2006 (LED - if applicable)
ISO 9001:2015
ISO 13485:2016