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BABY-COMP and later also LADY-COMP were tested by independent experts at an early stage. The results flowed continually into further development of the devices. Therefore, the Pearl-Index details were not based on the manufacturers information but were confirmed by repeated clinical tests. |
Rhodos 1988, Prof. Freundl, Frank-Herrmann, Tonkaboni. a) test on the exactness of the temperature readings Result: the temperature measurement is highly precise with p2 0,01 b) Test on reliability for contraception in comparison to clinical parameter Result: no unwanted pregnancies on "green" days c)Test on planning Result: 2 of 5 conceived already during the test. Amsteram 1992 Prof. Martinez, v. Hoof, Schoute, v.d. Meer Clinical test and research on hormones and temperature variations. Result: There is a good correlation and in BABY-COMP there is a device available, which can enhance the reliability and usability of the temperature method for the determination in fertility investigation. Erlangen 1994 Prof. Wildt Clinical testing and comparison with BABY-COMP. Result: perfect match between clinical findings and fertility indications of BABY-COMP. Advances in Contraception 1998; 14: 97-108 Prof. Freundl, Frank-Herrmann, Prof.Godehardt, Klemm, Bachhofer Clinical test of contraception safety of Lady-Comp and Baby-Comp with 686 women over 24 month and 12.213 cycles. Safety of the method Pearl-Index 0,7. FDA, January 2005 Office of Device Evaluation (ODE) LADY-COMP was approved as an aid in ovulation prediction. |
Barcelona Kongreß 1992 Prof. Freundl, Bauer, Bremme, Frank-Herrmann Test on fertile women in comparison with clinical parameters Definition: 6 days in a cycle are fertile Result: Lady-Comp found the ovulation in each cycle Number of fertile days shown: 11,1 +/-3. Length of cycles 25-35. No pregnancies on "green" days. Fertilität 1992 Nr.8 Seite 66-67 Clinical testing compared with BABY-COMP fertility indication. Result: in no case did BABY-COMP miss the beginning of the fertile days. Disturbances in the cycles were detected and analysed correctly. Sassari 1997 Prof. S. Dessol, Fadda, Rosas, Scapinelli, Indaudi, Ambrosini Test on women considered to be infertile for 3-8 years. The analysis of BABY-COMP was compared with a clinical method to determine ovulation. Result: 100% correlation on luteral deviciency, anovulatiory cycles and pregnancies. Clinicall test found 86% ovulations; BABY-COMP found 80%. Certification of production ISO9001:2000 ; ISO14001: 2004 Environmental Assessment Bavaria, Dec. 16th, 2005 Certification EMV EN60601-1-2 March 12th. 2007 LADY-COMP March 19th, 2007 BABY-COMP July 10th, 2007 pearly. Medical Evaluation, Dr. Andreas Marx - ClevaMed, Sept 20th, 2007 EG-Instruction 93/42 EWG and MEDDEV.e.7.1 "very high degree in Method-Security, with clearly stands out from competitive devices". |
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DITA e.K. Lady-Comp France is the official distributor for Baby-Comp, Lady-Comp & pearly in France, NRW-Germany and partner of Lady-Comp España. © 1998-2012 DITA e.K. + Valley Electronics GmbH Sitemap LadyComp & BabyComp | Data protection | Contact & Company Info | Terms of trade |