Tuttnauer Auto-reader User manual

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

Page 3
Index
Index......................................................................................................................................... 3
Constituent parts..................................................................................................................... 4
Description of use ................................................................................................................................................................4
References...............................................................................................................................................................................4
Symbols ...................................................................................................................................................................................5
Safety information .................................................................................................................. 5
Power supply specications.............................................................................................................................................5
Environment operating conditions ...............................................................................................................................6
Serial/Batch Number...........................................................................................................................................................6
Record Table...........................................................................................................................................................................6
Instructions for use.................................................................................................................. 7
Start-up ....................................................................................................................................................................................7
Thermal paper specications...........................................................................................................................................8
Replacement of the paper roll.........................................................................................................................................8
Reprinting of results............................................................................................................................................................8
Remaining incubation time..............................................................................................................................................8
Positive control......................................................................................................................................................................9
Interpretation of results.....................................................................................................................................................9
Disposal....................................................................................................................................................................................9
Audible alarm ........................................................................................................................................................................9
Canceling a reading.............................................................................................................................................................9
Temperature monitoring................................................................................................................................................... 9
Care and cleaning ................................................................................................................................................................9
Firmware update .................................................................................................................................................................10
Calibration..............................................................................................................................................................................10
Time zone change mode..................................................................................................................................................10
Time setting mode..............................................................................................................................................................11
Printing language change mode...................................................................................................................................12
Troubleshooting chart ........................................................................................................... 14

Page 4
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).
Incubation programs available: 3 hours at 60 ºC, 1 hour
at 60 ºC, 30 minutes at 60 ºC .
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.
The auto-reader allows selection of incubation time
programs for two zones in an independent way. Zone
1 includes positions 1 to 6, and zone 2 comprises
positions 7 to 12.
The incubator not only allows results detection but also
provides a printed ticket to record them. In addition,
the auto-reader can be connected to a computer by
USB. This allows linking the results with the Traceability
Software for Automatic Reading and Traceability of
Rapid Biological Indicators and Hygiene Monitoring
Systems.
Description of use
Constituent parts
15
16
1
2
3
10
11
9
12
13
14
8
612
7
References
Protective cover.
Red light/Positive indicator/Position Light.
Green Light/Negative indicator/Position Light.
Reading position number.
Program selector.
Temperature Selector.
Alarm Cancellation Button.
Thermal printer.
Printer’s light.
Paper’s traction button.
Cavity for paper.
USB port.
Input for power source plug (12V DC).
Control Panel.
Incubation area for 12 BIs. BIs Ampoule crusher.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16 Hole for external temperature control.

Page 5
Safety information
To avoid risks and damaging the equipment
-Do not place the auto-reader in an
environment exposed to direct sunlight or high
intensity light lamps.
-Do not place the auto-reader 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
disinfectans.
-In case of technical fault, contact the
manufacturer for support. Please, do not try
to open or repair the auto-reader 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 auto-reader 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:
Steam with 3hs. at 60 ºC program.
Power supply specications
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.
Symbols
Operating relative humidity.
Operating environmental temperature.
Caution, warning.
Caution: Risk of electric shock.
Caution: Hot surface.
Important, attention.
Manufacturer.
European conformity.
Serial number.
Direct current.
Product denomination.
80 %
30 %
10 ºC
30 ºC
REF
Steam with 1 h. at 60 ºC program.
Steam 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 printed
ticke
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.
-Do not use your nger for crushing BI.
To avoid a potencially hazardous situation:
avoid contact with the hot surface of the metal
auto-reader 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.
Input parameters
Voltage range
Frequency
Current
Output parameters
Voltage
Current
Operating
Condittion
(100-240)
50/60
0.2
Values
12
4
Units
Volts
Hertz
Ampers
Units
DC Volts
Ampers

Page 6
Environment operating conditions
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:
Safety information
Record Table
Use the following table to record rmware updates.
NOTE: manufactury rmware is printed on a label found
on the bottom of the auto-reader and on its packaging.
Environmental conds.
Altitude
Operation temperature
Relative humidity
Installation/overvoltage
Degree of contamination
Storage temperature
Voltage
Functional conds.
3500 (máx.)
10-30
30-80
category II
2
10-30
12
Units.
Meters
ºC
%
°C
DC volts
Date Version Operator
Please, register your manufactory rmware in this
manual for future reference:
Manufactury Firmware:

Page 7
Instructions for use
Start-up Do not put any biological indicator in the
reading positions until the auto-reader does
not conrm temperature stability.
The auto-reader will keep the selected incubation
program during the reading process. The system does
not allow to modify the incubation program once the
reading process has begun, unless the reading is nished.
6-Start readings once the blue temperature
selection’s light remains stable, this indicates that
incubation temperature was reached. Once the
selected temperature has been reached and remains
stable, after turning on the equipment, a one-
time automatic check of the Biological Indicators
incubation positions will be carried out. Indicating
lights of each well will turn on bringing the result, a
green light will show a satisfactory result while
a red light will indicate error.
When the equipment detects an error in any position,
a ticket indicating the day, time and position involved
will be printed.To guarantee the reliability of the results,
these positions will be deactivated, thus preventing
their use. To evidence this, the red light of that
position will remain blinking indenitely, in order to
indicate that the position has been disabled.
For a correct automatic check, the protective
cover of the auto-reader should be in its place.
Read BIs instructions for use. Before placing
the vials in the auto-reader, press the top to
seal the tube. Crush the ampoule (using the
ampoule crusher within the box of BIs or the
one located within the incubation area of the
auto-reader) 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 indica-
tor is incubated. For more information refer to
the Positive Control section of this user guide.
7-Place the rapid BI in a reading position and wait for
the result. Reading will start automatically. Immediately
after placing the BI in a position, an alarm will sound
indicating that reading has successfully began and the
position LED will blink until the result is informed.
NOTE: If the auto-reader does not run automatically,
it might indicate that the auto-reader 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-If the incubator detects a positive result, 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
IB from the incubation position, the alarm and the red
All equipment is manufactured with the
following settings:
- Time zone: UTC +0:00
- Printing language: English
For changing time zone, refer to Time zone change
mode section.
For changing printing language, refer to Printing
language section.
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.
2-Turn on the machine by connecting the end of the
AC power supply to the mains and then connect the
other end of the source (plug) on the rear of the unit.
The printer’s paper indicator light will turn on, if this
light becomes intermittent, this means that the thermal
paper must be loaded, or that the printer cover is not
tightly closed. Otherwise, the light will remain stationary.
The machine will start running the last time and
temperature set-up.
3-Synchronize the incubator with local time using the
auto-reader’s Traceability software. For this, connect a
PC to the USB plug of the auto-reader and start the
program. The incubator will be synchronized with the
time in the PC. Synchronization can be done as long
as there is not an ongoing reading.
4-The incubator will initiate with the last setup program
for temperature and time. To change the incubation
temperature, press the button for 3 seconds. Lights
corresponding to 60 °C will start blinking, indicating
that a temperature program must be selected. For
temperature selection, press the button to select
60 ºC. After 4 seconds the temperature modication
will be accepted.
For 60 ºC, 30 min., 1 or 3 hrs. program can be selected.
It’s possible to select dierent programs for each half
or the same for both, depending on the indicator's nal
reading characteristics. Check that the time setting is
appropriate for the BIs to be incubated in each zone.
To change the time program, press the button
of the correspondent zone as many times as needed
to choose the right setting.
5- Wait for temperature of the machine to be
stable. Once is stable, the indicator of the desired
temperature will remain steady.

Page 8
Replacement of the paper roll
Instructions for use
The printer uses thermal paper rolls.
Thermal paper specications
Reprinting of results
The auto-reader allows reprinting of the last 12 results
by uorescence readout. To print the results, press the
button for 5 seconds.
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 30 min.
(60 ºC),1 h. (60 ºC) or 3 hs. (60 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
informed 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, press paper’s traction button,
take the paper and press up for the paper to be cut
with the serrated edge of the printer.
NOTE: If the paper runs out, printer’s blue light will
start blinking (see Replacement of the paper roll in the
printer). The incubator will save the last 12 results, for
re-printing, follow the Reprinting of the last results
instructions.
1. To replace the paper
roll, pull the handle of
the printer’s door.
2. Open the printer’s
cover and remove the
spent roll.
3. Place the new paper
roll with the outer side
up.
4. Close the printer
cover by pressing on the
sides of the lid.
Remaining incubation time
The auto-Reader also allows verifying the remaining
incubation time in every reading position. Whenever
a reading process is in course, press and hold the
button for ve seconds, a ticket will then be
printed containing the following information:
reading position, incubation program and remaining
incubation time.
Recommended paper: JUJO AF50KSE3 or similar
(order code ICTP).
Paper width : 58 mm
Maximum paper thickness: 60 g/m2
Maximum diameter size: 50 mm
POSITIVE CANCELEDNEGATIVE

Page 9
Positive control
Disposal
Interpretation of results
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
long 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 well of the auto-
reader.
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.
-Proper functioning of the auto-reader.
Dispose Bls after use, according to your healthcare
and safety regulations (see BIs instructions for use).
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 30 min. (60 ºC), 1 h. (60 ºC) or 3 hs.
(60ºC) according to the used program, indicates that
the sterilization process was eective.
Take action on any positive result inmediately.
A positive result indicates a sterilization process
failure may have ocurred. Determine the cause of
the positive BI following current facility policies and
procedures. 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 environment 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. If the sterilization process
was successful, the media will remain unchanged.
Color change to yellow of the growth media shows
a failure in the sterilization process. If after the
incubation time (see biological indicators directions
for use), no color change is noticed in the processed
indicators, then the result is negative (the sterilization
process was successful).
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.
Audible alarm
Temperature monitoring
Care and cleaning
An audible alarm will sound every time a positive
result is detected in the auto-reader. 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 .
The auto-reader contains an internal temperature
control. If the temperature falls outside of the
specied range (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 back
of the device.
Canceling a reading
When a BI is removed from it’s position during
incubation process, an audible alarm will sound
to indicate the tube should be returned to the
corresponding position.
If the indicator isn’t re-introduced into the reading
position after 10 seconds of being withdrawn, the
reading will be cancelled and the cancellation will be
informed through the printing of a ticket.
Clean the exterior surface of the auto-reader with
a damp cloth moistened with an small amount of
detergent. Do not clean interior components. If
additional cleaning of the wells 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.
NOTE: Auto-reader does not need routine maintenance.

Page 10
Instructions for use
Firmware update
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 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, make sure that the
Traceability software is closed. 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 equipment calibration procedure is described in
the attached software manual (Traceability Software for
Automatic Reading and Traceability of Rapid Biological
Indicators and Hygiene Monitoring Systems).
Calibration
This function allows you to advance or delay the internal
auto-reader clock in order to adopt a dierent time
zone.
Time zone change mode
Enter Time zone change mode
De-energize the auto-reader.
NOTE: when entering Time zone change mode a
green light will turn on in one of the incubation/
reading position. This number corresponds to the
current auto-reader time.
Press and hold both buttons simultaneously and
energize the equipment. A beep will be emitted to
indicate access to Time zone change.
Time zone change
To advance time, press button as many times as
hours you need to advance. To delay time press
button as many times as hours you need to delay.
NOTE: 37 °C light indicates a.m. 60 °C light indicates p.m.
Advance Delay

Page 11
Instructions for use
Cancel time zone change
To cancel time zone change process without saving
the changes, disconnect power source.
Enter Time setting mode
De-energize the auto-reader.
Time setting functionality allows you to establish a
specic time regardless of auto-reader current time.
Press and hold both buttons and button
simultaneously and energize the equipment. A beep
will be emitted to indicate access to Time setting
mode.
Complete time zone change
To save changes press and hold button (Figure
4) for three seconds. A beep will sound indicating that
process has been completed successfully. A ticket
with the new set time will be printed.
Hours setting
Lights corresponding to 1 to 10 incubation/reading
positions indicate the digit value which is set. Lights
from 1 to 9 indicate digit value from 1 to 9. Light 10
indicates 0 value.
In time setting mode, light 1 from PRO sector will turn
on to indicate ten hour modication and incubation
light corresponding to the 10th position will turn on to
indicate setting started.
NOTE: 24-hour format.
- Hours setting: Ten hours (Hh:mm)
The blue light number 1 corresponding to PRO sector
should be on. If any other light from PRO sector is on,
press button as many times as necessary to
turn on the blue light number 1. This indicates ten
hour setting.
Figure 4
Figure 5
Time setting mode
To change hours and minutes digits, use
and buttons. To increase digit value press
; to decrease press (see Figure 5).
To increase ten hours value, press button. To
reduce ten hours value, press button. (See Figure 5).
NOTE: the possible values for ten hour are 0, 1 and 2.
- Hours setting: Unit hours (hH:mm)
Press button to turn on the blue light number
2. This indicates unit hours setting. If any other light
from PRO sector is on, press button as many
times as necessary to turn on the blue light number 2.
Increase Decrease

Page 12
Instructions for use
To increase unit hours value, press button.
To decrease unit hours value, press button. (See
Figure 5).
To increase ten minutes value, press button. To
decrease ten minutes value, press button. (See
Figure 5).
NOTE: possible values for ten minutes are 0, 1, 2, 3,
4 y 5.
Minutes setting
- Minutes setting: Ten minutes (hh:Mm)
Press button to turn on the blue light number
3. This indicates ten minutes setting. If any other light
from PRO sector is on, press button as many
times as necessary to turn on the blue light number 3.
- Minutes setting: Unit minutes (hh:mM)
Press button to turn on the blue light number
4. This indicates unit minutes setting. If any other light
from Pro sector is on, press button as many
times as necessary to turn on the blue light number 4.
To increase unit minutes value, press button. To
decrease unit minutes value, press button. (See
Figure 5).
Finish hours setting
To save changes press and hold button (see
Figure 4) for three seconds. A beep will sound, PRO
green light will turn on and a ticket with the new set
time will be printed to indicate the procedure has
been completed successfully.
NOTE: If the modication has not been done correctly,
the auto-reader will emit 3 beeps and the red light
from PRO sector will turn on. Repeat the procedure.
Cancel hours setting
To cancel hours setting procedure without saving the
changes, disconnect power source.
This function allows you to change the auto-reader
printing language.
NOTE: each language has a code number assigned:
1English
2Spanish
3 Portuguese
4 Turkish
Printing language change mode
Press and hold button and energize the equipment.
A sound will be emitted to indicate Access to Printing
language change mode.
Enter to Printing language change mode
De-energize the auto-reader.

Page 13
Instructions for use
Finish printing language change
To save changes press and hold button for
three seconds. A sound will be emitted indicating
that process has been completed successfully. A
ticket with the new language will be printed.
Use and buttons to select the position number
corresponding to language code.

Page 14
Troubleshooting chart
Fault Possible cause Action
The auto-reader does not start
The auto-reader gives an
error in one position during
“Autotest”.
The auto-reader gives an error
in the “Autotest”.
The auto-reader does not run a
BI reading.
The red light of that position is
blinking.
The auto-reader does not run a
BI readout in any position.
The auto-reader does not allow to
change the incubation program.
The printer does not print and
the printer indicating light blinks.
The printer releases unprinted
paper.
The traceability software does
not detect the auto-reader.
The update of the auto-reader
fails.
Power source is not connected.
A BI is placed in the position
at the moment of starting the
auto-reader.
Soil 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.
The auto-reader is turned o or
the USB cable is disconnected.
The auto-reader is connected to
the traceability software.
Check that the power source is
connected to the power supply and
that the plug is connected to the
auto-reader.
Check that every position is empty
at the moment of starting the auto-
reader.
Ensure cleanliness of the incubation
position. Use of air is recommended.
Do not use solid objects that could
damage internal components.
Restart the auto-reader.
Make sure that the position is empty
when starting the auto-reader.
Restart the auto-reader.
Wait for temperature to be stable.
Wait for the readings to nish.
Check that the cover is tightly closed.
Place a new paper roll in the right
direction.
Check the paper roll direction.
Check that the auto-reader is turned
on, the USB cable is connected and
the COM port is correctly installed and
accepted by the operative system.
Close the program, restart the auto-
reader and try again.