Device Description and Intended Use
14
4
Section 4 - Device Description and Intended Use
The G210 InviCell is a bench-top long-term incubator comprised of ten independent chambers for
gamete/embryo development and one larger preparation chamber. The larger preparation chamber
is not used for embryo development. The device is a non-sterile, reusable piece of equipment.
The incubator is used to culture gametes and embryos for up to 6-7 days in a controlled environment
(temperature, CO
2
/O
2
), normally in culture media contained within a culture dish. The CO
2
and O
2
concentration are monitored by sensors located in a chamber internal to the incubator chassis. The
gas is constantly recirculated from the culture chambers through a HEPA (high-efficiency particulate
air) / VOC (volatile organic compound) filter.
The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory that monitors pH
by surrogate media samples using a fluorescent marker contained in a disposable sample cup. When
this cup is properly placed in the sensor fixture, the cup does not come in direct contact with the
culture dish or gamete/embryo. This disposable cup is supplied sterile and is single use.
The G210 InviCell overall dimensions are 860mm wide x 550mm deep x 180mm high, with a weight
of 53kg (maximum).
Indications for Use
The G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended
to provide a controlled environment at or near body temperature and gas levels (CO
2
, O
2
, and N
2
) for
the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive
Technology (ART) treatments.
The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring
of surrogate samples of bicarbonate-based culture media used for ART procedures.
Applicable Part Numbers
Order Code
Description
K59500
G210 InviCell Standard
K60000
G210 InviCell Plus with SignipHy™ pH Monitoring System
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.
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.
