Tuttnauer WTL198-0057 User manual

Rev.0 | October 2019
Warning: this product contains dry natural rubber

Index
Index......................................................................................................................................... 3
Composition............................................................................................................................. 5
Use description .....................................................................................................................................................................5
References...............................................................................................................................................................................6
Safety information .................................................................................................................. 6
Symbols ...................................................................................................................................................................................6
Power supply specications.............................................................................................................................................7
Environment operating conditions ...............................................................................................................................7
Serial/Batch Number...........................................................................................................................................................7
Record Table...........................................................................................................................................................................8
Instructions for use.................................................................................................................. 8
Start-up ....................................................................................................................................................................................8
Remaining incubation time.............................................................................................................................................10
Positive Control....................................................................................................................................................................10
Interpretation of results....................................................................................................................................................10
Disposal...................................................................................................................................................................................10
Audible alarm .......................................................................................................................................................................10
Cancellation of a reading..................................................................................................................................................11
Temperature monitoring..................................................................................................................................................11
Thermal paper specications..........................................................................................................................................11
Replacement of the paper roll........................................................................................................................................11
Reprinting of results...........................................................................................................................................................11
Care and cleaning ...............................................................................................................................................................11
Firmware update .................................................................................................................................................................11
Setup Mode...........................................................................................................................................................................12
Modication of time zone................................................................................................................................................12
Modication of printing language................................................................................................................................12
Time setting mode..............................................................................................................................................................12
Troubleshooting chart ........................................................................................................... 13

Page 5
The Auto-reader incubator has been designed for the
incubation and automatic readout of Self-Contained
Biological Indicators (SCBIs).
The auto-reader allows easy and rapid detection
of positive and negative Biological Indicators (BIs).
Microorganisms contained within the Biological
Indicators vary depending on the sterilization process for
which they have been designed, therefore, incubation
temperatures dier depending on the indicator.
Indicators for Ethylene Oxide (EO) sterilization control,
should be incubated at 37 ºC, while those involved in
the monitoring of the rest of the sterilization processes
should be incubated at 60 ºC.
Simultaneous incubation of BIs for EO processes
control along with BIs monitoring the other
processes, is not possible.
Use description
Composition
Six incubation programs are available: 4 hours at 37 ºC,
3 hours at 60 ºC, 2 hours at 60 ºC, 1 hour at 60 ºC, 30
minutes at 60 ºC and 20 minutes at 60 °C. A positive
result can also be evidenced by culture medium color
change to yellow, read the instructions for use of each
indicator for more information. The choice to perform
or not the extended incubation to conrm by color
change depends on the internal protocols of each
laboratory or hospital.
Incubator allows incubation time programs selection
independently for each one of three positions. The
incubator not only allows results detection but also
provides a printed ticket to record them.
1
2
34
5
6
17
16
18
7
8
9
11
12 13
10
14
15

Page 6
Protective Cover.
Green Light / Negative Indicator.
Red Light / Positive Indicator.
Blue Attention light.
Incubation Position.
Programs Selectors for Incubation / Time Left
Control Panel.
Incubation Area.
1
2
3
4
5
6
7
8
9
10
Temperature Selector.
Sound Alarm Cancellation.
Thermal Printer.
11
12
13
14
15
16
17
Conguration / Paper Traction Button.
Cavity for paper.
USB Port.
Input for power source plug (12Volts DC).
Hole for external temperature control.
Reprint of Results.
Ampoule Crusher.
References
Safety information
Symbols
To avoid risks and damaging the equipment:
-Do not place the incubator in an environment
exposed to direct sunlight or high intensity light
lamps.
-Do not place the incubator near devices that emit
electromagnetic elds.
-Do not use the equipment on vibrating surfaces.
-Do not pour any liquid inside.
-Do not immerse into any liquid.
-Use indoors only.
-Disconnect the power cord before cleaning.
-Do not use abrasive, corrosive cleaners or
disinfectants.
-In case of technical fault, contact the manufacturer
for support. Please, do not try to open or repair the
incubator on your own, since this will imply the
loss of product warranty and could lead to a major
and irreversible damage.
-Make sure that the incubator is connected to a
properly rate power cord.
To reduce the risk of using incompletely
sterilized loads:
-Make sure to use each BI with its incubation and
reading program:
EO with 4 hs. at 37 ºC program
18
Operating/storage relative humidity.
Operating/storage environmental temperature.
Caution, warning.
Important, attention.
Direct current.
Waste Electrical and Electronic Equipment.
Batch number.
80 %
30 %
10 ºC
30 ºC
LOT

Page 7
Power supply specications
Environment operating conditions
Input
parameters
Voltage range
Frequency
Current
Output
parameters
Voltage
Current
Operating
conditions
(100-240)
50/60
0,5
Operating
conditions
12
2
Units
Volts
Hertz
Ampers
Units
DC Volts
Ampers
It is recommended to use a UPS instead of stabilizers,
since the former has two functions: it stabilizes and
provides a continual power source during energy cuto.
Environmental
conditions
Altitude
Operation temperature
Relative Humidity
Installation/overvoltage
Degree of contamination
Storage temperature
Voltage
Functional
conditions
3500 (máx.)
10-30
30-80
Category II
2
10-30
12
Units
Meters
ºC
%
ºC
DC Volts
Safety information
STEAM with 3hs. at 60 ºC program
STEAM with 1 h. at 60 ºC program
STEAM with 30 min. at 60 ºC program
STEAM with 20 min at 60 ºC program.
VH2O2 with 2 hs. at 60 °C program
VH2O2 with 30 min at 60 ºC program.
-Check that culture medium completely wets the
spore carrier.
-Do not remove the BI until the equipment reports
the nal readout result, check the impresion of the
ticket.
To avoid the risk of injury, because of glass
fragments generated after the glass ampoule
inside the BI tube is crushed:
-Cool the BI during the indicated time before
crushing the ampoule.
-Do not handle the BI excessively since this might
cause the glass ampoule to burst.
-Wear safety glasses and gloves when removing
the BI from the sterilizer.
-Wear safety protective glasses and gloves to crush
the ampoule and to press the cap of BI.
To avoid a potencially hazardous situation:
Avoid contact with the hot surface of the metal
incubator block.
To avoid BIs from absorbing uorescent
residues: Avoid BIs direct contact with chemical
indicators or tapes.
Do not use this product in a manner not specied
in this manual, otherwise the protection provided
by the product might be aected.
Do not replace the power supply cord for other not
provided within the product.
Only qualied personnel can access the inside
of the incubator and its components. Parts or
components inside the machine should not be
manipulated by the user.
Serial/Batch Number
For easy identication, each auto-reader has a unique serial
number and a batch number printed on a label found at
the bottom of the auto-reader and on its packaging. Please,
register your serial number and batch number in this manual
for future reference:
Serial number:
Batch number:

Page 8
Instructions for use
Record Table
Use the following table to record rmware updates.
NOTE: manufacture rmware is printed on a label found
at the bottom of the incubator and on its packaging.
Please, register your manufactory rmware in this manual
for future reference:
Manufacture Firmware:
Date Version Operator
Start-up
1-Place the auto-reader on a rm surface, free from
vibrations, away from sunlight, currents of hot or cold air,
chemicals and corrosive or ammable substances. Do not
place the equipment in a way that disconnection of the
plug from the power supply could be dicult. Leave a
gap of at least 10 cm from the wall. Do not move the auto-
reader periodically or during its use. Connect the auto-
reader to a secure and stable electrical power source.
Do not wet or heat the auto-reader. If liquid is
spilled on the auto-reader, disconnect it and dry
it immediately. Before turning on, verify that all
reading positions are empty.
To verify the proper functioning of the equipment,
readout of unexposed BIs should be performed in every
incubation position. The result from this readout should
be positive. Follow the instructions of this guide in order
to carry out readout.
2- Turn on the incubator by connecting the end of the
AC of the power supply to the power source and then
connect the other end of the source (plug) on the rear of
the unit. The equipment will start by running the last time
and temperature set-up.
3-Synchronize the incubator with local time. See
conguration methods in the Time setting mode section
All devices are manufactured with the following
settings:
- Time zone: UTC +0:00
- Printing language: English
If you want to change the time zone, refer to Modication
of time zone section. If you want to change the print
language, refer to Modication of print language section.
4- Check that required incubation temperature is correct.
To change it, press button for 3 seconds. Lights
corresponding to 37 ºC and 60 ºC will start blinking,
indicating that the temperature program must be
selected. Press the button to select the incubation
temperature program, 37 ºC or 60 ºC. After 3 seconds,
temperature modication will be accepted.
For 37 ºC, the auto-reader will automatically select 4 hs.
nal readout for all positions.
For 60 ºC the incubator allows choosing between 20
minutes, 30 minutes, 1 hour, 2 hours or 3 hours nal
readout. It is possible to select an incubation program
for each of the positions depending on the nal reading
characteristics of the indicators to be used.

Page 9
Check that the time setting is appropriate for the BIs to be
incubated in each position.
To change the time program, press the button of the
correspondent position as many times as necessary to
choose the right setting.
5- Wait for the temperature of the machine to be stable.
Once is stable, the indicator of the desired temperature
will remain steady.
Do not place any biological indicator in read
positions until the incubator does not conrm
temperature stability.
The incubator will keep running the incubation program
during all reading process. The system does not allow the
incubation program to be modied once the reading is
started, except it has been completed.
6- Reading can be initiated when the temperature blue
light remains stable indicating that incubation temperature
was met. Then an automatic testing of the status of the
incubation positions of the biological indicators will be
performed. The indicating lights of each position will
be turned on to show the result: green light will show a
satisfactory result while red light will indicate error.
When the device detects an error in any position, it will
print a ticket indicating date, time and positions with error.
To guarantee the reliability of the results, these positions
will be deactivated avoiding their use. To make this clear,
red light in that position will remain blinking indenitely to
indicate that the position has been disabled.
For the correct performance of the automatic
check, it should be done with the protective cover
closed.
Read BI´s instructions for use. Before placing the
vials in the incubator, press the top to seal the tube.
Crush the internal ampoule (using the ampoule
crusher within the box of BIs or the one located
within the incubation area of the incubator) and
make sure that the liquid has completely wet the
spore carrier placed at the bottom of the biological
indicator plastic tube.
Do not remove or change placement of BI once the
reading process has begun. If this occurs, results
may be invalidated.
Use a non-sterilized biological indicator as a
positive control every time a processed indicator
is incubated. For more information refer to the
Positive Control section of this user guide.
7- Place the rapid BI in a reading position, close the
protective cover and wait for the result. Reading will
start automatically. Immediately after placing the BI in a
position, the auto-reader will emit a sound alarm indicating
that reading has successfully began and status position
light will turn on and will blink until the result is informed.
NOTE: If the incubator does not run automatically, it
might indicate that the incubator temperature is not
steady yet (check the temperature indicating light to
remain steady) or that the incubation position is disabled
due to an error in the initial autotest.
8- When a positive result is detected, the red light and
the audible alarm will turn on. This will indicate that
the sterilization process to which the BI was subject,
has failed. 30 seconds after removing the BI from the
incubation position, the alarm and the red light will turn
o automatically and the position will be available to start
a new reading. The negative BIs will be informed with a
green light in the corresponding position, this will indicate
that the sterilization process to which it was subject has
been successful. The green light will remain on for up to 30
seconds after the BI is withdrawn from the reading position.
The incubator will inform results within 20 min. (60° C), 30
min. (60 ºC),1 h. (60 ºC), 2 hs. (60 °C), 3 hs. (60 ºC) or 4 hs.
(37 ºC), according to the program selected. These periods
of incubation are the time-limits used by the equipment
to inform the uorescence nal readout.
9- Every time a positive result is detected, it will be infor-
med through the printing of the corresponding ticket
and with an audible alarm. The alarm can be cancelled by
pressing the button .
10- To register the tickets, take the paper and press up for
the paper to be cut with the serrated edge of the printer.
NOTE: If the paper for ticket printing runs out, the attention
blue light will ash rapidly. To replace the paper, follow the
instructions in Replacing the roll paper in the printer. The in-
cubator will save the last 3 results, for re-printing, follow the
Reprinting of the last results instructions.
Instructions for use
POSITIVE CANCELEDNEGATIVE

Page 10
The auto-reader allows verifying the remaining incubation
time in every reading position by ticket printing. Whenever
a reading process is in course, press and hold the button
for 3 seconds, a ticket will then be printed informing
reading position, incubation program and remaining
incubation time. To verify remaining incubation time
of 2 or more readings in course press 2 buttons
simultaneously; the device renders a ticket informing
remaining incubation time of all positions.
Remaining incubation time
Instructions for use
The positive control should belong to the same
batch of the processed BI.
Use a non-sterilized biological indicator as a
positive control every time a processed indicator is
incubated.
Incubate the processed biological indicator and the
indicator used as positive control as specied in the
instructions.
Press the cap to seal the tube and crush the ampoule, make
sure the media completely wets the carrier. Write a C (for
control) and the date on the label. The positive control can
be placed in any position of the incubator. The positive
control should belong to the same batch of the processed BI.
It is a good practice to use a positive control, this helps
ensuring:
-Correct temperature is reached.
-Viability of spores has not been altered due to improper
storage temperature, humidity, or proximity to chemicals.
-Capability of the media to promote rapid growth and
uorescence generation.
-Proper functioning of the incubator.
Rapid Readout
The indicator used as positive control should show a
positive result (red light ). The processed BI results
are not valid until the biological indicator used as positive
control shows a positive result . A processed BI
with a positive result, indicates a failure in the sterilization
process. A negative result, (green light ) after 20
min. (60 ºC), 30 min. (60 ºC), 1 h. (60 ºC), 2 hs. (60 °C), 3
hs. (60 ºC) 4 hs. (37 ºC) according to the used program,
indicates that the sterilization process was eective.
Take action on any positive result immediately. Always
retest the sterilizer and do not use the sterilizer for
processing loads until 3 consecutive BI results are negative.
Visual Readout
The Rapid readout system allows the conrmation of
results by color change after 48 hours or 7 days incubation
analysis (if 7-day readout is made, an humidied incubator
will be required to avoid media dry out). If the sterilization
process was not successful, the growth media contained
in the indicator will turn to yellow, as it is shown in
Instruction for Use of BIs. If the sterilization process was
successful, the media will remain unchanged.
The color of the growth media in the BI used
as positive control must turn to yellow during
the process of incubation for the results to be
valid. Record the positive ones and discard them
immediately as shown in the biological indicators
instructions for use.
Dispose Bls after use, according to your healthcare and
safety regulations. Positives BIs can be sterilized (see BIs
instructions for use). It is not possible to reuse a BIs.
Positive Control
Disposal
Interpretation of results
An audible alarm will sound every time a positive result
is detected by the incubator. The alarm allows the user
to immediately detect a positive result without the need
to visually control the equipment. The alarm can be
cancelled by pressing the button .
Audible alarm

Page 11
Instructions for use
When a BI is removed from its position during incubation
process, an audible alarm will sound to indicate that the
tube should be returned to the corresponding position.
If the indicator is not re-introduced into the reading
position after 10 seconds of being withdrawn, the reading
will be cancelled and the cancelation will be informed
through the printing of a ticket.
Cancellation of a reading
The incubator contains an internal temperature control.
If the temperature falls outside of the specied range
(37±2) ºC or (60±2) ºC, the blue temperature led light will
start to twinkle.
Temperature can be externally monitored by using a
thermometer. The auto-reader has a special hole for
placing the thermometer which is located at the right
side of the device.
Temperature monitoring
Care and cleaning
Replacement of the paper roll
Thermal paper specications
Recommended paper: JUJO AF50KSE3 or similar.
Paper width : 58 mm
Maximum paper thickness: 60 g/m2
Maximum diameter size: 23 mm
The printer uses thermal paper rolls.
1. To replace the paper
roll, pull the handle of
the printer’s door. Open
the printer’s cover and
remove the spent roll.
2. Place the new paper roll
with the outer side up.
3. Close the printer cover
by pressing on the sides
of the lid.
NOTE: You can check the correct paper replacement by
pressing , this button will force the advance of the
paper a few centimeters.
The incubator allows reprinting of the last 3 results by
uorescence readout. For printing the results, press the
button for 3 seconds.
Reprinting of results
Clean the outer surface of the incubator with a damp
cloth moistened with a small amount of detergent. Do
not clean interior components. If additional cleaning of
the internal components of the equipment is required,
contact your distributor or manufacturer.
Always unplug the auto-reader and allow it to cool
before cleaning. Do not immerse the unit in liquid.
NOTA:The auto-reader does not need routine maintenance.
The auto-reader allows updating the rmware periodically
(program that controls the device and denes its dierent
features) through the use of a rmware update utility.
This software veries, by using the internet, the latest
Firmware update

Page 12
This functionality allows changing the language in which
the incubator printer renders the tickets.
To make this change, the device must be started in Setup
mode (see Setup Mode), then press the button .
The current language and list of available languages will
be printed to establish a reference. Press the button
to scroll up and to scroll down. After 2 seconds, a
ticket will be printed informing the selected language.
To conrm the change, press and hold the button for
3 seconds. To discard the change, unplug the incubator
from the power source.
Instructions for use
Setup Mode
Modication of time zone
Modication of printing language
The auto-reader has a setup mode from which, the device
time zone and the print language can be set up. To enter
Setup mode, turn on the incubator while holding down
the button . The red and green LEDs in the three
positions will remain on, indicating that the device is in
this mode. The printer will render a ticket indicating that
it is in Setup Mode.
To change the time zone and the print language, follow
the instructions below. When nished, restart the
incubator to exit Setup mode.
Time setting mode
Change the time using the rmware update utility
Connect the auto-reader via the USB port to a PC and
start-up the program. Select the Auto-reader and
press the Clock Sync button, the auto-reader will be
synchronized with the PC’s clock. Synchronization can
only be done as long as there is not an ongoing reading.
rmware version available for the auto-reader; downloads
it and installs it in a few seconds without the loss of any
device data.
Update procedure
Before starting the process, turn o the incubator for ve
seconds, then turn it on and follow these steps:
1-Connect the incubator to a PC using a USB cable and
make sure to have an internet connection.
2-Open the rmware update utility.
3-Select the device and press Start button to update.
4- Wait until the software indicates that the upgrade process
is complete. The auto-reader prints an update conrmation
ticket. If it was already up to date, it will print nothing.
NOTE: This process must be repeated every time a new
rmware version is available, this will be informed in the
website.
The time zone modication function allows changing the
time zone of the device to suit the time zone of your country.
To make this change, the incubator must be started in
Setup mode (see Setup Mode), then press the button.
The current time will be printed to set a reference.
To subtract hours, press the button as many times as
necessary. To add hours, press the button as many
times as necessary. After 2 seconds, a ticket will be printed
informing the selected time.
To conrm the change hold down the button for
3 seconds. To discard the changes, unplug the incubator
from the power source
.

Page 13
Troubleshooting chart
The incubator does not start.
The incubator gives an error in
one position during “Autotest”.
The incubator gives an error in
the “Autotest”.
The incubator does not run a BI
reading.
The red light of that position is
blinking.
The incubator does not run a BI
readout in any position.
The incubator does not allow
changing the incubation program.
The printer does not print and
Attention indicator light blinks
quickly.
The printer releases unprinted
paper.
Power source is not connected.
A BI is placed in the position at the
moment of starting the incubator.
Dust particles might be
obstructing the light path
between the sensors.
The “Autotest” gives an error in
that position, which becomes
disabled.
The incubation temperature is not
stable.
Ongoing reading.
The printer cover is not tightly locked.
Printer without paper.
Paper roll is placed in the wrong
direction.
Check that the power source is
connected to the power supply
according to its characteristics and that
the plug is connected to the incubator.
Check that every position is empty at
the moment of starting the incubator.
Ensure cleanliness of the incubation
position. Use of air is recommended.
Do not use solid objects that could
damage internal components. Restart
the incubator.
Make sure that the position is empty
when starting the incubator. Restart the
incubator.
Wait for temperature to be stable.
Wait for the reading of corresponding
position to nish.
Check that the cover is tightly closed.
Place a new paper roll in the right direction.
Check the paper roll direction.
Fault Possible cause Action