Safety Instructions; About The Minc Mini Incubator; Intended Use; Intended Users And Use Environment - COOK Medical K-MINC-1000 Manual De Instrucciones

K-MINC-1000 Instructions for Use

1. Safety instructions

WARNING: Please familiarise
yourself with the safety instructions
before using the MINC.
WARNING: ELECTRIC
SHOCK HAZARD.
WARNING: Do not sterilise
the device.
WARNING: No user serviceable
parts inside.
WARNING: This device
should only be operated by
appropriately qualified personnel
WARNING: EXPLOSION
HAZARD. Device can cause
explosion in presence of
flammable gases.
WARNING: Use the correct
gas connecting hose.
WARNING: Use only
original disposables.

2. About the MINC Mini Incubator

This manual describes the operation and intended use of the MINC Mini Incubator (MINC) for devices with serial
numbers from A803560 onwards.
It is essential to use this manual to familiarise yourself with the functions and the operation of the MINC before use.
Not following these instructions can result in damage or breakdown of the device.
Internal circuitry is energised whenever the MINC is connected to mains power, irrespective of whether or not the
displays are illuminated. Always disconnect the device from mains power before cord replacement or cleaning.
Should any power cord or plug associated with the incubator become cracked, frayed, broken or damaged it must
be replaced immediately.
To reduce the risk of electric shock, do not remove covers. Please refer all servicing to the manufacturer's authorised
service agent.
Protect the MINC from being splashed by liquid. Should any liquid enter the device, discontinue use
immediately.
Do not use the MINC in an area where flammable gases are present.
Use only the Braided PTFE lined gas connecting hose supplied with the MINC Mini Incubator to connect it to a gas
supply. The use of another tubing type may result in the loss of desired gas concentrations.
For your own safety, use only original disposables (see § 7).

2.1 Intended use

The MINC Mini Incubator (MINC) is a microprocessor controlled, gassed, humidified, incubator intended for use in
cell culture.

2.1.1 Intended users and use environment

The K-MINC-1000 Mini Incubator device is intended to be used by clinical embryologists. Service personnel may
install the K-MINC-1000 Mini Incubator and will routinely service the device.
The K-MINC-1000 Mini Incubator is intended to be used within an IVF laboratory.

2.2 Contraindications

There are no known contarindications for this device.

2.3 Device description

The K-MINC-1000 Mini Incubator is a microprocessor controlled, gas humidified incubator intended for use in cell
culture. The incubator is designed to be used in conjunction with the K-MINC-CTS-S humidification flask. The incu-
bator does not contain a medicinal product. The incubator is an active therapeutic device intended to administer
energy.
The MINC is designed to maintain temperature accurately at a user specified temperature within the range of
35 to 40°C, and to maintain accurate gas flow at a user specified flow rate within the range of 15 to 25 mL/min.
The MINC utilises premixed gas to maintain optimum culture conditions within the incubation chambers.
All components in contact with the gas flow, including external and internal gas lines, have undergone rigorous
testing to ensure a toxin free environment.
The MINC has the ability to accept NUNC® four well culture dishes, or NUNC® and FALCON® 35 mm and 60 mm
single round culture dishes in two separate chambers. The two chambers have individual temperature control
whilst the single gas flow control applies commonly to both chambers.
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 with the gas mix occurs to re-establish the required environment.
The MINC enhances safety by continuously monitoring the critical functions. Deviation from normal operation
is immediately detected and the user is alerted to the detected fault. The device can be connected to an external
remote alarm to alert staff out of normal working hours to any problems that the device is unable to self-correct
in the allotted time.
The K-MINC-1000 Logger Software is a PC based program that is used to continuously record the operating state
of up to 10 devices. The software monitors the behaviour of the MINC, but will not control the device. This software
can only be used with MINC's with serial numbers from A803560 onward.

2.4 Precautions for device use

Should any electrical or mechanical fault occur while using the MINC, stop using the device until it has been
checked by an authorised service agent.
1-4
English
1