Prima C/ Prima CS COLPOSCOPE
WARNING LABELS AND NOTES
9
6128000-795
Prima C/ Prima CS
Issue 2.2
Printed on November,2020
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-in-
vasive 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 colposcope provided with the CE mark
indicates agreement with the legal Stipulations.
QUALITY MANAGEMENT
LABOMED has an established quality management system according to ISO 9001:2015/ 13485:2016 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 user 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 8600-5 First edition 2005-03-15 Optics and phonetics-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 Risk management to medical devices.
DIRECTIVE USED
•
IEC 60601-1-3.1 edition (2012)
•
IEC 60601-1-2 4th edition (2014)
•
EN 55011:2016
•
MDR 2017/745 Annex IX and Rule B
CLASSIFICATIONS
•
For Europe, per MDR 2017/745, the unit is a Class I instrument.
•
For the United States, the FDA classification is Class I.
•
Please observe all applicable accident prevention regulations.
INTENDED USE
LABOMED Colposcope 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 abnormalities 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.
CONFIGURATIONS
Colposcope
Catalogue No.
PRIMA C
6128000
PRIMA CS 6128600
