MIRI
®
II-12 Multiroom IVF incubators User Manual Rev. 4.0
12
The total gas consumption is very low. Less than 2 l/h CO
2
and 5 l/h N
2
in use.
For safety reasons the multiroom IVF incubator has a very complete gas control system that
consists of: pressure regulator (preventing dangerous gas pressure problems), gas flow
sensors (actual consumption can be accumulated), gas pressure sensors (then user knows
that the pressure and variation can be logged to avoid dangerous conditions), gas filters (to
avoid valve problems).
Petri dish location in a compartment is easy to reach and safe because of the compartment
numbering and the ability to write on the white lid with a pen.
The multiroom IVF incubator has been primarily developed and designed for incubation of
gametes and embryos with an overlay of either Paraffin or mineral oil.
The multiroom IVF incubator has a built-in PC which operates the Esco Medical Data logger
software for long-term data logging and data storage.
USB module enables the QC data to be transferred for off-site evaluation
–
by performing
this, the manufacturer can provide a valuable service to the customers (MIRI
®
II-12).
A pH sensor port is part of the DAQ package. The user can plug any standard BNC pH probe
to the unit and measure the pH in the samples at will.
The device is manufactured under a full EU certified 13485 ISO quality management
system.
This product fulfils the requirements of EN60601-1 3rd edition standards as a Class I type
B equivalent device suited for continuous operation. It also 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 MIRI
®
II-12 multiroom IVF incubators. Also, the MIRI
®
II-12 multiroom
IVF incubators does not contains 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.
5 Transport, Storage and Disposal
5.1 Transportation requirements
The device is packed in a carton box, and it is wrapped in polyethylene. The box is affixed to
a pallet with special straps.
