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K-MINC-2000 Instructions for Use
6.4 Six monthly functionality testing
To preserve the MINC+ and maintain its performance, regular inspections
are necessary for early detection of possible device malfunctions. The
user or a qualified technician must regularly test the device to assess its
functionality.
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The following must be tested every six months:
• Temperature
• Gas flow rate
• External alarm contacts. The functionality of the external alarm
contacts is also checked internally each time the MINC+ is powered on.
It is therefore recommended that the power to the device be turned off
at regular intervals, such as during cleaning and flask replacement as a
suggested minimum.
6.4.1 Temperature
Set each chamber temperature to 37.0 °C. Insert a thin wire thermocouple
through the gas outlet tube into the chamber, as shown in the diagram
below. Ensure that the sensor wire is thin enough that it does not occlude
the gas flow. Place a Nunc four-well dish into the front outer dish location
of each chamber so that the well with the thermocouple is in the position
shown below. Fill the well that has the thermocouple with 1 mL of water,
close the chamber lid, and allow enough time for the thermocouples to
thermally equilibrate. The temperature reading should be 37.0 ± 0.2 °C.
If the measurement lies outside the acceptable range, contact your Cook
Medical service agent.
To measure the temperature, the thermocouple must be secured so that
the tip is immersed in the fluid and touching the bottom of the dish and
remains in that position when the dish lid is fitted and the chamber lid
is closed. It is recommended that the thermocouple and thermometer
readout be calibrated at 37.0 °C to compensate for any offset between
the actual temperature and the indicated value, if required.
Thermometer
The temperatures measured will be the temperature set point ± 0.2 °C.
IMPORTANT NOTE: To avoid damaging the lid seal, do not pass the
thermocouple wire through the lid seal.
6.4.2 Gas flow rate
To test the gas flow rate:
1. Insert a fully filled flask into each HF bay.
2. Wait until a normal flow cycle is initiated and the rate of bubbling
appears stable.
3. Count the number of bubbles formed against each flask front face
over a one-minute period. The number of bubbles formed in each
flask should be at least 9 per minute. The bubble count per minute
can vary significantly between flasks; it may be in excess of 25
bubbles per minute.
6.4.3 External alarm contacts
To test the external alarm contacts, ensure that at least one heater chamber
is active and then disconnect the MINC+ from mains power. The contacts
should open or close (depending on which one is the normal position)
approximately 2 minutes later. The contacts should actuate to the opposite
of their normal state. After you confirm that the contacts have actuated,
reconnect the device to the mains power. The contacts should then reset
to their normal position (i.e., normally open or normally closed).
If the contacts fail to actuate, contact your Cook representative.
Thermometer
6.5 Inspection by an authorized Cook Medical service agent
WARNING: No user serviceable parts inside!
Inspections at least once a year
For ongoing operational performance of the MINC+, an authorized Cook
Medical service agent must maintain the device annually. The service
agent will assess the operational functionality of the water level detector,
gas flow and temperature control systems, and external alarm contacts.
Authorized service agents
All services such as alterations, repairs, calibrations, etc., may be
performed only by the manufacturer or by service agents who are
authorized by the manufacturer.
Liability
The manufacturer is free from all liability for the operational safety of
the MINC+ if the device is willfully opened and unauthorized persons
perform repairs or alterations on it during the warranty period.
Certification
The MINC+ owner will receive a signed certificate from the service agent
for all inspections or repairs. This certificate states the type and scope of the
services rendered, the service date, and the name of the service company.
Technical documentation
If the manufacturer provides technical documentation, this does not
authorize the user to perform repairs, adjustments, or alterations to the
MINC+ or disposables.
6.6 Return procedure
WARNING: BIOLOGICAL HAZARD. Before you return a product, you
must clearly mark it with a contamination warning and seal it in a plastic bag
that is sealed within a second plastic bag. When you ship the MINC+, remove
the humidification flasks and all chamber contents prior to transport.
IMPORTANT NOTE: When returning goods, use the original packaging.
The manufacturer does not take responsibility for damage that occurrs
during transportation if the damage is caused by inadequate transport
packaging.
All devices or disposables that are to be returned must be prepared as
described below for the protection of the service agent and for safety
during transportation.
To return the MINC+
1. Reset the MINC+ to its factory settings to remove patient and dish
information. Refer to Section 5.4.22.
2. Clean the unit as detailed in the cleaning Section 6.2.
3. Place in the original packaging. Ensure that the device is in the
original bag and that the bag is sealed with tape.
4. Enclose the following information:
• Owner's name.
• Owner's address.
• Model type.
• Serial number of the equipment (located on the rear of the MINC+,
or found by tapping Settings and then tapping Information on
the center console).
• Description of the damage or fault.
The manufacturer has the right to refuse to carry out repairs if the
products received are contaminated.
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