CultureCoin
®
User Manual Rev. 7.0
8
large well is provided outside the culture for pH measuring without affecting the cultured
samples. The dish has a flat bottom, so it is ideal for heat transfer from below.
Principles of operation of the device and its mode of action: CultureCoin
®
is designed to
culture cells only in Esco Medical Technologies MIRI
®
TL
family’s
multiroom IVF
incubators for a period of up to 6 days. The capacity of droplets in incubation wells is
25μl.
Such an amount of media is sufficient for cell development during such a period. A
high wall surrounds the droplet area to ensure enough space for an oil overlay to secure
media from evaporation. Incubation wells are situated in one line, at the same height and
across the exact distance between well centers. It perfectly fits the design of the MIRI
®
TL
family’s
multiroom IVF incubators, which camera moves under CultureCoin
®
along
incubation wells.
Model Code: MRI-CC.
With CultureCoin
®
dishes could work only individuals with formal education in a relevant
field of healthcare or medical discipline.
The CultureCoin
®
's intended target groups are IVF patients. Patients are women in their
reproductive years who have fertility health issues. The intended target group indication
is IVF treatment. There are no intended target group contraindications.
CultureCoin
®
is a medical device intended for use on one patient during a single
procedure. It is not intended to be reprocessed (cleaned, disinfected/sterilized) and used
on another patient.
CultureCoin
®
can be used only with the MIRI
®
TL
family’s
multiroom IVF incubators and
sequential media specifically designed for IVF treatment. CultureCoin
®
cannot be used
with non-medical devices and other non-IVF treatment-designed media.
The device is manufactured under a full EU certified 13485 ISO quality management
system.
This product conforms to the requirements of the Regulation (EU) 2017/745 concerning
medical devices and is classified as a Class IIa device under rule II.
Personal Protective Equipment (89/686/EEC) and Machine Directive (2006/42/EC) is
not applicable for the CultureCoin
®
. Also, the CultureCoin
®
do not contain or
incorporates: a medical substance, including a human blood or plasma derivate; tissues
or cells, or their derivates, of human origin; or tissues or cells of animal origin, or their
derivatives, as referred to in Regulation (EU) NO. 722/2012.