Download V4 Ceiling Lift TECHNICAL DOCUMENTATION

V4 serie Technical file
Technical file content
1
Introduction ________________________________________________________________________________________4
1.1
Product identification_____________________________________________________________________________4
1.2
Manufacturer and location_________________________________________________________________________4
1.3
Subcontractors and location________________________________________________________________________4
2
Standards procedure _________________________________________________________________________________5
2.1
CE Marking procedure ___________________________________________________________________________5
2.1.1
Route of compliance _________________________________________________________________________5
2.1.2
Declaration of conformity _____________________________________________________________________5
2.1.3
National and European device classification (annex IX) ______________________________________________5
2.2
European Directives and Standards: _________________________________________________________________5
2.2.1
Directive Medical Devices 93/42/EEC ___________________________________________________________5
2.2.2
Directive 73/23/EEC Electrical Equipment ________________________________________________________5
2.2.3
European Standard: 89/336/EEC ________________________________________________________________5
2.2.4
Risk Analysis (EN 1441 for Europe): security and performance________________________________________6
2.3
Authorized European Union representation____________________________________________________________6
2.4
Specific standards _______________________________________________________________________________6
2.4.1
ISO 10535 _________________________________________________________________________________6
2.4.2
CSA 601.1 (EN 60601.1, UL 2601.1) ____________________________________________________________6
2.4.3
CSA Z323.5-1998 ___________________________________________________________________________6
2.5
Lifetime of products _____________________________________________________________________________6
2.6
Quality Assurance, procedures and certificate__________________________________________________________7
2.7
Post-Market Surveillance__________________________________________________________________________7
2.7.1
Complaints and incidents reported_______________________________________________________________7
3
2.7.2
Advisory notices and recalls ___________________________________________________________________7
2.7.3
Competent authorities ________________________________________________________________________7
Description of Product________________________________________________________________________________8
3.1
General Description ______________________________________________________________________________8
3.1.1
Description of product ________________________________________________________________________8
3.1.2
Parts description____________________________________________________________________________10
3.1.3
Dimensions _______________________________________________________________________________10
3.1.4
Definition of product family __________________________________________________________________12
3.1.5
Functional purpose of the device (intended use) ___________________________________________________12
3.1.6
Variants of the device _______________________________________________________________________12
3.1.7
Records of significant changes to the device design ________________________________________________12
3.2
Use information ________________________________________________________________________________12
3.2.1
Advertising/Warning ________________________________________________________________________12
3.2.2
Intended patient population and medical condition _________________________________________________12
3.2.3
The reasonably foreseeable medical conditions is not be used ________________________________________12
3.3
Market information _____________________________________________________________________________13
3.3.1
Warranty _________________________________________________________________________________13
3.3.2
Photograph of product and use ________________________________________________________________14
3.3.3
Brochure, advertising, marketing claims _________________________________________________________14
3.3.4
Packaging specifications, transport and storage conditions ___________________________________________14
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