BABY GUARD

TECHNOLOGY FOR SAFE NATURAL CHILDBIRTH

medical PC

electrophysiological signal amplifier

trolley

ergonomic belt

worn Vivis belt

Vivis ergonomic belt

THE ONLY MULTIFUNCTIONAL TECHNOLOGY FOR THE SAFETY OF MOTHER, BABY AND HEALTHCARE PROFESSIONALS FOR A STANDARDIZED, REGULATED AND ETHICAL NATURAL DELIVERY

pneumatic control box

FOR MEDICAL DOCTOR AND MIDWIFE USE Baby Guard is a Medical Device that detects feto maternal bioelectrical signals and accompanies the uterine contractions with the use of a soft, ergonomic, air inflatable, disposable belt in the second stage of labor in spontaneous childbirth. It can also be used in labour analgesia and with the application of the vacuum extractor.

Baby Guard consists of: Ergonomic Air inflatable belt (inflation section), divided into three different chambers. At first the right and/or left chambers are filled according to the pressures set by the operator, that are completely safe for mother and foetus, for the purpose of gently guiding the fetus in the correct position towards the pelvis.

Once the correct foetal position has been obtained, the three chambers of the belt are inflated in sync with each contraction (always at the discretion of the medical/midwife staff and the mother) in order to accompany the uterine contractions during the second stage of labor, and improve the control of the direction of the applied force; Electrophysiological signal amplifier (monitoring section) detects feto-maternal bioelectrical signals:maternal heart rate, fetal heart rate, uterine electromyographic activity; Doppler recording of fetal heart rate.

inflating section

Maternal heart rate

Fetal heart rate

monitoring section Maternal bioelectrical signal

Fetal bioelectrical signal

All the parameters and signals detected are saved on a hard disk that can be connected to the central hospital information system.

Baby Guard observes all the European Directives regarding the adapting of health structures in line with the childbirth SAFETY parameters for the mother, foetus and health operators.

Optional digital video camera for saving videos on the PC hard disk and DVDs at the mother's discretion.

Baby Guard Medical Device - EC Certificate no. 1466/MDD

Classified as a Class IIa medical device according to DM 93/42/EEC and subsequent amendments (2007/47/EEC).

Compliant with the UNI EN 60601-1 and UNI EN 60601-1-2 standards.

Complete system compliant with the UNI EN 60601-1-1 standard.

EC Certificate no. 1466/MDD. Pneumatic control box

Electrophysiological signal amplifier

"Vivis" ergonomic air inflatable abdominal belt

BABY GUARD standardize the second stage of labour reducing health care costs

ADVANTAGES OF THE VIVIS INFLATABLE ERGONOMIC ABDOMINAL

BELT

BEST MATERNAL PHYSICAL AND PSYCHOLOGICAL APPROACH TO NATURAL DELIVERY; HIGHER DEGREE OF POSTPARTUM SATISFACTION: USEFUL IN LABOUR ANALGESIA; NO NEED TO APPLY THE UTERINE FUNDAL PRESSURE MANEUVER (KRISTELLER MANEUVER) DURING SPONTANEOUS OR INSTRUMENTAL DELIVERY (VACUUM EXTRACTOR, FORCEPS); PHYSICAL AND PSYCHOLOGICAL FATIGUE OF THE PARTURIENT REDUCTION LESS NUMBER OF REQUESTS BY THE PARTURIENT TO DELIVER BY CAESAREAN SECTION DURING THE SECOND PHASE OF LABOR; SEPARATE DETECTION OF FETAL HEARTH RATE AND MATERNAL HEART RATE.

Baby Guard utilizes a new clinical protocol for assuring safety of mother, baby and healthcare professionals, as well as ensuring proper ethical and legal approach to childbirth, while harmonising the technical procedures with informed consent, clinical chart and social security contributions, cutting currently concealed costs, and eliminating risk factors.

www.baby-guard.it www.baby-guard.net info@baby-guard.it

Distributed by: ®

Safefactory srl Registered Office: Via San Niccolò n°107 50125 Firenze Italy Operational Office: Viale G.Galilei, 1/A 50125 Firenze Italy Tel. (+39) 055 225683 Cell. (+39) 334 1423249 info@safefactoryweb.com www.safefactoryweb.com Manifactured by: CABEL Costruzioni Elettroniche S.a.S.