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Section 4 - Intended Use
To provide an environment with controlled temperature at or near body temperature and gas level
(CO
, O
and N
), for the development of human gametes and embryos during in vitro fertilization
2
2
2
(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 G210 InviCell for clinical use is dependent on the regulatory
approval status of the incubator within that country.
Applicable Part Numbers
Order Code
K59500
K60000
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
woman's uterus, with the intention of establishing a successful pregnancy.
User Profile
A trained health professional, who has the appropriate assisted reproduction technologies qualifications.
Only qualified personnel trained in using the G210 InviCell should operate the incubator.
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.
InviCell Standard Incubator
InviCell Plus Incubator
/O
). It is then implanted in the same or another
2
2
Intended Use
Description
4
11
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