EN
1.7
Cleaning and Disinfection
The SonoTT
TM
Ultrasonic FlowComputer and SonoTT
TM
Clamp-On Transducer must be cleaned and disinfected
before the first use and after every use. Only the materials and processes recommended by the manufacturer
may be used for the cleaning and disinfection of the device and its accessories. The prescribed instructions
for use are to be carefully followed.
Additionally, please follow the legal regulations valid in your country and the hygiene regulations for your
doctor’s office or hospital.
1.8 Biocompatibility
The SonoTT
TM
Ultrasonic FlowComputer and accessories have been made from conventional materials which,
with appropriate use, are harmless for the patient and the user according to current knowledge.
1.9 Set-Up Procedure
Safety measures, including a set-up procedure with a check list for extracorporeal circulation are recommended
by the guidelines related medical associations.
The responsible organization using the SonoTT
TM
Ultrasonic FlowComputer should implement sufficient set-
up procedure and documentation to ensure that the SonoTT
TM
Ultrasonic FlowComputer with the connected
sensors work as expected and that settings are correct. The check should include visual inspection of the
sensors for damages at the cable, connectors, and housings and cleanness of the sensor surfaces. This should
ensure that all failures or faults in the device or the settings are detected before a patient is connected to an
extracorporeal circuit. Additioanlly, national standards e.g. the third edition of “ISO/TS 23810 Cardiovascular
implants and artificial organs - Check lists for use of extracorporeal circulation equipment” provide additional
information regarding adequate organizational measures and should be taken into account.
1.10 Electrical Safety
To avoid the risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
The SonoTT
TM
Ultrasonic FlowComputer fulfills the requirements of the IEC 60601-1 3
rd
ed. and IEC 60601-2-
37 2
nd
ed. The electrical installation of the room where the device is going to be used must comply with the
requirements of the IEC60364-7-710 1
st
ed. or equivalent national or international standards.
When using this flow meter in combination with other medical devices, the sum of the leakage currents
needs to be checked.
It shall be assumed that the person who assembles or changes the medical-electrical systems will undertake
the necessary steps to ensure that the requirements of the standard IEC 60601-1 3
rd
ed. are fulfilled.
Additional devices, which are connected to interfaces of the SonoTT
TM
Ultrasonic FlowComputer have to meet
the requirements of the appropriate IEC-standards.
SonoTT
TM
Ultrasonic FlowComputer
Copyright em-tec GmbH
D108-702 SonoTT
TM
Ultrasonic FlowComputer - Operating Instructions V4.0
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