Labomed Prima C User Manual page 11

User's Manual Prima C/ Prima CS COLPOSCOPE
Directives and standards
CE Certification
The device is tested according to the specifications of the European Medical Device Directive [MDD]
93/42/EEC, and fulfills the necessary standards concerning the German Medical Product Law. This
product belong to Class I of non-invasive products, according to Appendix IX of EU Guideline
93/42/EEC and checked for compliance with the basic requirements according to Appendix I of
Guideline 93/42/EEC. All the colposcopes provided with the CE mark which indicates agreement with
the legal stipulations.
Quality Management
LABOMED has an established quality management system according to ISO 9001:2008 /
13485:2004 and USFDA 21 CFR 820 cGMP requirements. Regular internal auditing is the key for
continuous improvements. Monitoring by authorized external auditors guarantees the agreement with
the respective international standards.
The instrument described in this manual has been designed in compliance with the following standards:
•
ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 Optics and Optical instruments-Medical
endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of
endoscopes with optics.
•
ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments-Medical endoscopes and
endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes
with optics.
•
ISO 8600-5 First edition 2005-03-15 Optics and photonics-Medical endoscopes and
endotherapy devices- Part 5: Determination of optical resolution of rigid endoscopes with optics.
•
ISO 9001/13485 quality management systems approved by UL (notified body).
•
ISO 14971-2007 Risk management to medical devices.
Directives used
•
Directives 93/42/EEC, Annex II, Article 3.
•
rd
IEC 60601-1-3 edition (2005).
•
IEC 60601-1-2
•
EN 55011:2007
Classification
•
For Europe, per Directive 93/42/EEC, the unit is a Class I instrument
•
For USA: FDA classification Class II
•
Please observe all applicable accidental prevention regulations.
•
Please observe all applicable accidental prevention regulations.
• Intended Use
LABOMED colposcopes Prima C / CS is a device designed to permit direct viewing of the tissues of
the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose
abnormilities and select areas for biopsy. It helps the user an excellent level of comfort and
improves visual acuity during use.
•
Note: The use of Prima C / CS Colposcope is purely for intended Operative and Diagnostic
medical use. No contact is to be made between the patient and the device.
• Configuration:
Microscope
PRIMA C
PRIMA CS
9
6128000-795
Catalogue No.
6128000
6128600
Prima C/CS
Issue 2.0
Printed on Oct, 2016