COOK Medical MINC+ Mode D'emploi page 19

K-MINC-2000 Instructions for Use
4.14.8 First time commissioning run
Ensure that the following actions are carried out before the first use:
1. Both chamber heaters and gas flow to each chamber, should be
turned on for 24 hours to ensure that any residual outgassing of
components is complete.
2. Install the humidification flasks in both incubation chambers and turn
on the gas flow for at least 4 hours to saturate the water with CO
3. Use a culture media that contains phenol red indicator to test each
chamber for pH maintenance. After overnight incubation, look to see
if the phenol red indicator is the correct color (salmon pink).
4. If the DishTrace PC software has been running during the
commissioning run, download the PDF file for each device, and check
that the performance and function of the device are satisfactory.
The MINC+ is now successfully installed and commissioned.
4.15 Installation and setup checklist
All items have been supplied.
The packaging has been safely stored for future use.
All nonsterile items have been removed from packaging.
The power cord is the correct format for the region.
The MINC+ has been placed in a suitable location.
The appropriate gas mixture has been determined.
An appropriate gas regulator has been sourced.
The gas regulator has been set to 150 ± 15 kPa.
The gas connections have been made and checked.
The humidification flask has been aseptically filled and fitted.
External alarms have been connected.
The MINC+ has been switched on.
The MINC+ has been configured.
The gas flow to the chambers has been activated.
The MINC+ has been left to operate for 24 hours to ensure that any
residual outgassing of components is complete.
Check the following for the DishTrace PC software (optional)
The installation USB flash drive has been supplied.
A computer with the appropriate specification is available for using
the DishTrace PC software.
The DishTrace PC software has been installed on the desired computer.
A direct or LAN network connection between the incubator and PC
exists.
The MINC+ devices have been activated.
Users group has been populated and secure connectivity established
between each PC with DishTrace PC and each MINC+ on the closed
network.
5. Device operation
This section describes how to use the MINC+. When operating the MINC+
for the first time, follow the instructions below to ensure that the device
performs reliably.
Only the clinician or embryologist can evaluate the clinical factors for
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each patient and determine if the use of this device is indicated. The
clinician or embryologist must decide on the specific technique and
procedure that will accomplish the desired outcome.
WARNING: To guarantee safe operation, properly care for and
maintain the device and perform regular checks to confirm that the device
is functioning correctly. New and repaired products must be prepared and
tested according to the MINC+ instructions before use.
IMPORTANT NOTE: Ensure that gas supply is available to the MINC+.
Each chamber's heater must be on to enable gas flow into the chamber.
5.1 Before use
Prior to commencing the culturing procedure, perform the
following steps:
• Use the temperature-selection touchpads to select the desired
chamber temperature (refer to Section 4.14.3).
• Fill the humidification flasks with sterile water and install them as
detailed in Section 4.10.
• Confirm that the humidification flasks and gas tubes are correctly
installed.
• Activate the required incubation chambers.
• Activate the gas flow (see Section 4.14.5).
• Ensure that gas bubbles can be seen in the humidification flask during
both the gas purge and normal flow cycles.
• Wait a minimum of four hours before using the incubator to allow for
equilibration.
5.2 Inserting culture dishes
The MINC+ has been designed to be compatible with Nunc four-well
dishes and Nunc and BD Falcon 35 mm and 60 mm single round culture
dishes. Equivalent dishes maybe used, however the user must ensure
correct fitment as described below.
Four-well dishes or single round dishes can be placed on the chamber
base. Ensure that they sit securely in the grooves designed to accept
them. There should be direct contact between the base of the dish
and the surface of the chamber base. The height of the dish should not
interfere with the lid closure.
5.3 Patient identification plates
Twelve magnetic patient identification plates are provided with the
MINC+. Use the magnetic patient identification plates on the chamber
lids to record culture dish contents with a marking pen. Pen markings can
be removed with an alcohol solution.
Figure 15: Patient identification plates
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