Warning notes:
The product is:
Sterility / specific
microbial condition:
Single-use product /
reprocessing:
1.4 Function
The products are mains-operated medical suction devices designed for vacuum ex-
traction, temporary surgical suction and bronchial suction in newborns. The product is
employed during vacuum extraction to fix the baby's head with the aid of an extraction
cup. In addition, suction material (among other things: secretion, blood) is temporarily
collected in a collection canister and subsequently disposed of.
During operation, the pump generates vacuum in the secretion canister and hoses,
by means of which the extraction cup can be fixed on the baby's head. Furthermore,
secretion, blood and body fluids can be suctioned. The fluid is collected in the secretion
canister. The buttons allow you to set the final vacuum and thus the suction capacity
in steps. The set value can be read on the vacuum display. Once the final vacuum is
reached, the pump turns off and only continues working if suction capacity falls below
the final vacuum value.
Two vacuum extraction modes are available for vacuum extraction:
• SEMI: The device automatically generates a base volume level of −20 kPa (−200
mbar; 150 mmHg). After reaching the base volume level, the user can check the
correct positioning of the extraction cup. After confirming (by pressing button 1 (ON)
for switching on automatic vacuum build-up), the device generates the desired final
vacuum within the specified unit of time. Once the final vacuum has been reached,
the device indicates this audibly and visually.
• AUTO: The device automatically generates the desired final vacuum within the
specified unit of time. Once the final vacuum has been reached, the device indicates
this audibly and visually.
After completing vacuum extraction or at any other time, the vacuum extraction mode
can be stopped by pressing button 2 (OFF). The user can set the duration of the individu-
al phases as well as the level of vacuum to be built up in the user menu.
1.5 Intended users
The device may only be used by trained and instructed medical professionals.
The following complications can occur during vacuum extrac-
tion or suction:
• Cerebral haemorrhages
• Cephalohaematomas
• Skin abrasions on the child's head
• Haematomas
• Perineal, vaginal, cervical tears
• Bleeding
• Injuries to vessels and nerves
• Adhesion of the suction instrument
Active
Not a sterile product
The device and parts of the accessories are reusable. For
information on reprocessing, cleaning and disinfection, please
see the operating instructions.
Introduction
9