COOK Medical MINC+ Mode D'emploi page 8

K-MINC-2000 Instructions for Use
Each chamber has a display indicating the chamber status, the current
temperature, temperature set point, gas flow status, water level sensing
status, and any associated alarms.
The information displayed on each chamber screen can also be viewed
on the center console. The center console does not control the chamber
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operational parameters. These operational parameters can be changed
only by using the individual chamber keypads.
The MINC+ can accept Nunc® four well culture dishes, or Nunc and BD®
Falcon® 35 mm and 60 mm single round culture dishes, or equivalent
sized culture ware in two separate chambers. If using alternate culture
ware, the user must ensure that dish fits in the chamber, sits flat on the
base plate and locates correctly within the chamber base plate grooves.
The heater blocks under each culture dish are in direct contact with the
bottom surface of the dish. Whenever the chamber lid is opened and
closed, a rapid purge of the gas mix occurs to reestablish the required
environment.
The MINC+ provides performance security by continuously monitoring
critical functions. If a deviation from normal operation is detected, the
user is alerted. The device can be connected to an external remote alarm
to alert staff outside of normal working hours to any problems that the
device is unable to self-correct in the allotted time.
The media warming chamber (MWC) can be used to maintain a stable
temperature for test tubes containing IVF-related liquids such as media
or overlay oil. The MWC is not gassed and only provides a constant
temperature, which is manually set.
Dish data can be managed on the MINC+ via DishTrace MINC+ on the
center console touchscreen on the front of the device. The touchscreen
allows IVF clinicians to assign the locations of culture dishes within each
chamber, check the history of dishes previously logged, and check the
chamber temperature conditions.
The incubator may be connected to either an ethernet network or
directly to a personal computer (PC) via LAN cable connection.
The DishTrace PC software shows the status of multiple MINC+ incubators
connected on the PC network. It can connect up to 50 MINC+ Benchtop
Incubators, including up to 10 (K-MINC-1000) MINC Benchtop Incubators
(serial number A803560 onwards). DishTrace PC cannot control the MINC+
or the MINC incubator settings.
2.5.1 Humidification flask
The MINC+ uses a sterile, disposable humidification flask for each
incubation chamber. The purpose of the flasks is to humidify and direct
the gas into each chamber. The flask includes an internal filter to prevent
backflow from filled flasks from entering the incubator's internal gas
plumbing. The reorder code of the humidification flasks is K-MINC-2000-HF.
There are two humidification flasks included with the incubator. Each
flask is supplied sterilized with EtO (ethylene oxide) in a sealed pouch.
Each pouch includes:
• One humidification flask.
• One disposable funnel.
• One flask T-piece.
• One temporary support clip to aid in filling the flask.
Refer to Section 4.10 for more information
2.6 Precautions for device use
If any electrical or mechanical fault occurs while the MINC+ is in use, stop
using the device until it has been checked by an authorized Cook Medical
service agent. Complete the installation and setup checklist prior to
operating the MINC+ (see Section 4.15).
3. Prerequisites
A detailed checklist of prerequisites is provided for each component
further in the document. In summary, the following are needed:
3.1 MINC+ Benchtop Incubator (see Section 4 for details)
• Clean, secured laboratory environment.
• Stable mains power supply.
• Premixed gas supply.
• Sterilized distilled water for flasks.
• A 9/16" wrench (spanner) to connect the Braided Connecting Tube.
• Uninterruptible power supply (UPS) (recommended).
3.2 DishTrace PC (see Sections 4.13 and 5.5 for details)
• A PC running Microsoft Windows® 8.1 or 10 operating system.
• Mouse with center button scroll wheel.
• 4 GB of RAM.
• 10 GB of disc space for data storage.
• USB connection hub (up to 10 ports) for (K-MINC-1000) MINC Mini
Incubators.
• Ethernet connection for MINC+ connectivity.
• USB drive for backups from MINC+ (FAT32 format).
• Antivirus software (e.g., Microsoft Windows Defender Antivirus or
McAfee® for cybersecurity risk mitigation).
• All PC and software updates must be completed before DishTrace
PC is installed. A PC restart may be required during an update
process. Ensure that all Windows operating systems and application
updates have been completed and installed successfully. Refer to
Troubleshooting (Section 7), DishTrace PC install and connectivity,
for instructions on how to verify that the updates have been
successfully installed.
3.3 Network configuration
• DHCP server to assign dynamic IP addresses to each MINC+ incubator
and PC.
• NTP server to provide date and time information to the incubators.
• Ethernet LAN connection for the MINC+ incubator and DishTrace PC.
3.4 Cybersecurity
• MINC+ incubators and the PC running DishTrace PC should be on a
separate network segment that is firewalled from the business network
and the Internet to ensure appropriate security.
• Use a dedicated PC for the DishTrace PC software and avoid the use of
business productivity applications such as email, etc., on this PC.
• The PC used for DishTrace PC should be configured to require user
logon (no automatic logon).
• The PC used for DishTrace PC should have an antivirus program and
BitLocker® enabled.
• Ensure that physical access to the MINC+ incubators is restricted to only
authorized users.
• MINC+ patching and security updates must be installed and kept up to
date.
The MINC+ incubator has been designed to use only the following
network port services:
• HTTPS (TCP 443, bidirectional).
• NTP client (random UDP port above 1023, bidirectional).
• Autodiscover (UDP 5353, bidirectional).
• DHCP (UDP 68, bidirectional).
The following network ports are used by DishTrace PC:
• HTTPS (TCP 443, bidirectional).
• SQL (TCP 1433, bidirectional, localhost only).
• Autodiscover (UDP 5353, bidirectional).
IMPORTANT NOTE: In situations where it is necessary to retrieve
system logs from DishTrace MINC+ (e.g., cybersecurity event investigation),
contact your Cook Medical service agent for assistance.
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