Intended Use
11
4
Section 4 - Intended Use
To provide an environment with controlled temperature at or near body temperature and gas level
(CO
2
, O
2
and N
2
), for the development of human gametes and embryos during
in vitro
fertilization
(IVF) treatment.
Applicable indications for use are subject to the regulations of the country into which the device is
sold and also the availability of the G185 for clinical use is dependent on the regulatory approval
status of the incubator within the country.
Applicable Part Numbers
Order Code
Description
K22400-110
K22400-230
Standard Incubator
K22200-110
K22200-230
SensorTech Incubator
Significant Performance Characteristics
The incubator has been developed and optimized for gametes and embryos cultured with an overlay
of either paraffin or mineral oil. Each chamber is designed to contain dishes from one patient only.
Operation Principle
The fertilized egg (zygote) is cultured for up to 6-7 days in a growth medium in the incubator with
a controlled environment (temperature and CO
2
/O
2
). It is then implanted in the same or another
woman’s uterus, with the intention of establishing a successful pregnancy.
CAUTION:
If the equipment is used in a manner not specified by this manual, the
safety of the user may be at risk and the equipment may be damaged. Always use the
equipment as stated in this User Manual
Operating Environment
To be used at ambient temperature in a medical environment, clinic or hospital laboratory under
normal working conditions.
User Profile
A trained health professional, who has the appropriate assisted reproduction technologies
qualifications. Only qualified personnel trained in using the G185 should operate the incubator.
Summary of Contents for K-Systems G185 SensorTech
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