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首页爱克发CR-30X维修手册:全面英文版指南
爱克发CR-30X全套维修手册是一份专为爱克发CR系列型号,如5175/100/105/110/120/125的CR-30X型号设计的详细服务文档,版本为第一版,修订至第3版,发布日期为2010年11月,产地德国。这份手册由Agfa Healthcare N.V.制造商和Agfa-Gevaert HealthCare GmbH出版,适用于医疗影像服务领域,强调了其专业性和保密性。 手册包含了严格的版权声明,指出未经授权的人员复制、分发或传播此文档是不被允许且可能构成违法行为。文档控制信息表明,官方版本存储在MedNet系统中,纸质打印件被认为是未受控制的。每个章节的最新修订状态可以在GSOLibrary的订单列表中查找,以确保用户获取的是最新和最准确的信息。 "About this Manual"部分介绍了手册的目的,即为用户提供对CR-30X设备进行全面诊断、维护和修理的指导。它可能包括了设备的操作指南、故障排查步骤、部件更换说明、系统设置调整方法以及安全操作规程等内容,旨在帮助维修人员有效地处理可能出现的问题,保障设备的正常运行。 由于手册是英文版,因此阅读者需具备一定的英语基础,或者需要专业的翻译工具辅助理解。此外,手册还强调了Agfa Healthcare的公司机密性质,所有内容应仅限内部使用,不得对外公开,体现了公司对知识产权的保护和客户数据的保密政策。 爱克发CR-30X全套维修手册是诊断和维修该特定机型的专业工具,对于任何从事相关工作的技术人员来说,理解和掌握其中的知识点至关重要,以便于提升工作效率并确保设备性能稳定。
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DD+DIS238.06E
Generic Safety Directions
DOCUMENT CONTROL NOTE:
The controlled version of this document resides on MedNet. Any printed copy of this document is uncontrolled.
Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 10 of 28
07-2009 Agfa Company Confidential
4 Product Complaints
Any service person who has any complaints or has experienced any dissatisfaction in the
quality, durability, reliability, safety, effectiveness or performance of this product must
notify Agfa HealthCare by the Agfa HealthCare complaint procedure.
If the product malfunctions and may have caused or contributed to a serious injury of a
patient or an accident or if there are any hazards which may cause an accident
Agfa HealthCare must be notified immediately by telephone, fax or written
correspondence to the following address:
Agfa Service Support - local support addresses and phone numbers listed on:
www.agfa.com
Agfa – Gevaert N.V.
Septestraat 27
2640 Mortsel, Belgium.
Fax +32 3 444 4485
5 References
Technical Documentation is available via MedNet (PDF) and your local Agfa HealthCare
support organisation (Paper).
Access to MedNet:
IntraNet: http://docs.agfanet/bu/mi/mednet/mednetcso.nsf
ExtraNet: http://extranet.agfa.com/bu/mi/mednet/mednetcso.nsf
DD+DIS238.06E
Generic Safety Directions
DOCUMENT CONTROL NOTE:
The controlled version of this document resides on MedNet. Any printed copy of this document is uncontrolled.
Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 11 of 28
07-2009 Agfa Company Confidential
6 Intended Use
This Agfa HealthCare product should only be operated in a hospital or clinical radiological
environment by qualified staff.
It must only be operated according to its specifications and its intended use. Any
operation not corresponding to the specifications or intended use may result in hazards,
which in turn may lead to serious injuries or fatal accidents (for example electric shocks).
AGFA will not assume any liability whatsoever in these cases.
Make sure that the product is constantly monitored in order to avoid inappropriate
handling, especially by children.
The product must only be installed and put into operation under the specified conditions.
7 Intended User
This manual is written for Agfa trained Field Service Engineers and Clinical Application
Specialists, trained users of Agfa HealthCare products and trained diagnostic X–Ray
clinical personnel who have received proper training. Users are considered as the persons
who handle the equipment as well as the persons having authority over the equipment.
8 Qualifications for Operation and Service Tasks
This Technical Documentation describes adjustments and routines which must only to be
performed by qualified technical personnel.
The Agfa (trained) Field Service Engineers and Clinical Application Specialists must have
received adequate Agfa HealthCare training on the safe and effective use of the product
and applicable environmental and occupational safety matters before attempting to work
with it. Training requirements may vary from country to country.
Agfa (trained) Field Service Engineers and Clinical Application Specialists must make
sure that training is received in accordance with local laws or regulations that have the
force of law.
Your local Agfa HealthCare representative can provide further information on training.
DD+DIS238.06E
Generic Safety Directions
DOCUMENT CONTROL NOTE:
The controlled version of this document resides on MedNet. Any printed copy of this document is uncontrolled.
Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 12 of 28
07-2009 Agfa Company Confidential
9 Environmental and occupational Safety Instructions
Each Agfa (trained) Field Service Engineer and Clinical Application Specialist:
• Must make his or her personal contribution to improve safety and protect the
environment.
• When working on a customers site, has a duty to take reasonable care to avoid injury
to himself or herself or to others who may be affected by their acts or omissions.
• Is obligated to adhere strictly to regulations and instructions.
• Shall familiarise himself or herself with the provisions of the Agfa Healthcare
Health, Safety and Environment Policy and any specific rules or procedures relating to
occupational safety at work and the protection of the environment.
• Shall promptly report any near misses, accidents, incidents or dangerous occurrences
to their line manager and co-operate fully in any investigation.
• Shall co-operate with company management on matters relating to
health, safety and environment and, where appropriate, discuss with and / or assist
their manager in resolving matters relating to health, safety and environment.
• Shall ensure that any company equipment issued to them, or, for which they are
responsible, is correctly used and properly maintained.
• Shall wear protective equipment whenever instructed or if it is recommended to do so.
• Shall be responsible for good housekeeping in the area in which he or she is working.
• Shall report situations, which could put them at risk, on either company or
customers' premises, to their manager or supervisor; and, if warranted, directly and in
confidence, to the Health and Safety Co-ordinator, Global HSE Manager, or ultimately
to the Managing Director.
• Shall report any injuries, diseases or dangerous occurrences to his or her line
manager.
• Shall report any accidents, incidents or near misses to his or her line manager.
• Shall report any situation of which he or she is aware that is potentially dangerous.
• Shall comply with any health surveillance procedure instituted for his or her benefit or
for compliance with regulations.
DD+DIS238.06E
Generic Safety Directions
DOCUMENT CONTROL NOTE:
The controlled version of this document resides on MedNet. Any printed copy of this document is uncontrolled.
Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 13 of 28
10 Connections to other Equipment
Agfa HealthCare equipment must only be used in combination with other Agfa HealthCare
equipment or components if these are expressly recognized by Agfa HealthCare as
compatible. A list of such equipment and components is available from Agfa HealthCare
service on request.
Changes or additions to the equipment must only be carried out by persons authorized to
do so by Agfa HealthCare. Such changes must comply with best engineering practice and
all applicable laws and regulations that have the force of law within the jurisdiction of the
hospital.
The Agfa HealthCare products are designed to communicate with other devices in the
hospital network using DICOM protocols.
Connections to other equipment:
Warning:
Accessory equipment not complying with the safety requirements of this product
may lead to a safety hazard.
INSTRUCTION:
Consult the Technical Documentation before making any connections to other equipment.
Consideration relating to the choice of accessory equipment shall include:
• Use of the accessory equipment in the patient vicinity.
• Evidence that the safety certification of the accessory equipment has been performed
in accordance with the appropriate IEC 60601-1 and IEC 60601-1-1 harmonized
national standard.
In addition all configurations must comply with the medical electrical systems standard IEC
60601-1-1. The party that makes the connections acts as system Configurer and is
responsible for complying with the systems standard.
If required, contact your local service organization.
07-2009 Agfa Company Confidential
DD+DIS238.06E
Generic Safety Directions
DOCUMENT CONTROL NOTE:
The controlled version of this document resides on MedNet. Any printed copy of this document is uncontrolled.
Edition 1, Revision 3 Generic Safety Directions for HealthCare Imaging Products Page 14 of 28
11 Accessories and Spare Parts
Parts and accessories replacement:
WARNING:
Hazards may be introduced because of component failure or improper operation.
INSTRUCTION:
• Replace defective parts with Agfa HealthCare original spare parts.
• Use only tools and measuring instruments which are suitable for the procedure.
• Only approved Agfa HealthCare accessories must be used. For a list of compatible
accessories contact your local Agfa HealthCare organization or www.agfa.com.
12 Compliance
Directive for HealthCare Imaging Products:
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
(OJ No L 169/1 of 1993-07-12)
• ANNEX I - ESSENTIAL REQUIREMENTS - GENERAL REQUIREMENTS The
products are designed and manufactured in such a way that, when used under the
conditions and for the purposes intended and, where applicable, by virtue of the
technical knowledge, experience, education or training of intended users, they will not
compromise the clinical condition or the safety of patients, or the safety and health of
users.
• ANNEX II - EC DECLARATION OF CONFORMITY: Full quality assurance system
ISO 13485
• ANNEX X - CLINICAL EVALUATION: The clinical evaluation follows a defined and
methodologically sound procedure.
07-2009 Agfa Company Confidential
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