Many thanks to the Valley Electronics Research Department for supplying this information.
Clinical Tests and Reports on BABY-COMP® and LADY-COMP®
1. Medical Product, Directive 93/42/EEC, January, 2009
Quality Management, Medical Device, Directive 93/42/EEC
Quality Management, Voluntary participation in regular monitoring EN ISO13485:2003 + AC:2007.
2. Medical Evaluation, Dr. Andreas Marx – ClevaMed, Sept. 20th, 2007
EG-Instruction 93/42 EWG und MEDDEV.2.7.1
‘very high degree in Method-Security, which clearly stands out from competitive devices’.
3. Certification EMV EN60601-1-2
March 12th, 2007 LADY-COMP®
March 19th, 2007 BABY-COMP®
July 10th, 2007 pearly®
4. Certification of Production
ISO9001: 2000 / ISO14001: 2004
Environmental Assessment Bavaria, December 16th, 2005
5. Congresso della Societa Italiana della Contraccezione, June 16-18th, 2005 Lettura BABY-COMP®
Dr. Hubertus Rechberg: Contraception and Baby-planning with LADY-COMP® and BABY-COMP®
6. FDA, January 2005 Office of Device Evaluation (ODE)
as an aid in ovulation prediction
7. New York Observer, Juni 25th, 2004
Sheelah Kolhatkar: Orgasmatron shows up: High-Tech-Rhythm
8. Advances in Contraception 1998; 14: 97-108
Prof. Freundl, Frank-Herrmann, Prof. Godehardt, Klemm, Bachhofer
Trial of contraceptive effectiveness of LADY-COMP® / BABY-COMP®
Results: User Pearl-Index 0.7.
9. Düsseldorf 1998, Dissertation Bachhofer, Prof. Freundl, Frank-Herrmann, Prof. Godehardt, Klemm
686 women in more than two years use = Pearl-Index 0.7.
Field study in Switzerland, Germany and Mexico.
10. Sassari 1997, Prof. S. Dessole, Fadda, Rosas, Scapinelli, Inaudi, Ambrosini
Test on women sterille for 3 – 8 years. BABY-COMP® compared with clinical testing.
Results: 100% match on luteal deficiency, anovulatiory cycles and pregnancies.
Clinical found 86% Ovulation’s, BABY-COMP® 80%. (Original in English)
11. Birmingham 1997, Prof. Freundl
Test of 686 women over 24 month and 12.213 Cycles. Results: see below 8.
12. Erlangen 1994, Prof. Wildt
Clinical testing and comparison with BABY-COMP®.
Results: perfect match between clinical findings and fertility indications of BABY-COMP®.
13. Fertilität 1992, Nr. 8, Pages 66-67
Clinical testing compared with BABY-COMP® fertility indications.
Results: in no case BABY-COMP® missed the beginning of fertile time,
cycle disturbances were detected and treated right.
14. Amsterdam 1992, Prof. Martinez, v. Hoof, Schoute, v.d. Meer
Clinical Test and research on Hormone- and Temperature shifts.
Results: They do correlate and there is BABY-COMP® that might improve reliability,
acceptability and application of BBT in fertility investigation. (Original in English)
15. Barcelona Congress 1992, Prof. Freundl, Bauer, Bremme, Döring, Frank-Herrmann
Test on fertile women. Compared with clinical testing.
Definition: 6 Days are fertile.
Results: LADY-COMP® found temperature shift in each cycle. Number of fertile days 11.1 +/- 3.
Length of cycles 25-35. No pregnancy on ‘green’ days. (Original in English)
16. Rhodos 1988, Prof. Freundl, Frank-Herrmann, Toncaboni
a) test on preciseness of temperature readings
Results: Temperature readings highly precise p2 0.01.
b) test on prevention compared with clinical testiness.
Results: no unwanted Pregnancies on ‘green’ days.
c) test on planing.
Results: 2 out of 5 conceived already during the test. (Original in English)
The original document can be downloaded here.
