Tristel Stella System A User manual

1
USER GUIDE
System

CONTENTS
PAGE NO.
SECTION 1 INTENDED USE 1
SECTION 2 COMPONENTRY 3-7
SECTION 3 GETTING STARTED 9-10
SECTION 4 HOW TO USE 12-18
Stella System A 12-13
Stella System B 14-15
Stella System C
16-18
SECTION 5 MAINTENANCE 20-25
Battery Management 20
Lubing IQ Process 20
Bluetooth Pairing Process 21
Barcode Validation 21-22
Downloading 22-23
Replacing the Pump Hose and Tube Set 24-25
Cleaning and Disinfecting Stella 25
SECTION 6 TROUBLESHOOTING AND FREQUENTLY ASKED QUESTIONS 27-30
SECTION 7 WARRANTY 32
SECTION 8 COMPLIANCE 34-42
SECTION 9 STELLA AGENTS 44-45
The Operating Instructions in this manual outline general safety guidelines for the correct operation of Stella System,
applicable to all variants.
Ensure that the device to be reprocessed is compatible with the Stella System prior to use.
Carefully read and understand the user instructions before operating Stella, IQ, or Pulse.
Never use Stella, IQ, Pulse, or Cradle for any purpose other than the Intended Purpose.
Do not use Stella for the reprocessing of surgical equipment or medical devices intended for autoclaving.
Do not use Stella IQ, Pulse, or Cradle, including IQ or Pulse power adaptors, if they have been damaged or have
changed in performance.
Should IQ or Pulse appear to malfunction, download the data and follow the graphic messages on the IQ display.
This will allow you to take appropriate corrective action or to arrange for repair.
All repairs must be carried out by an approved and qualied Stella service technician.
The Stella System can only be used in combination with Tristel Fuse for Stella for semi-automated disinfection.
The Stella System can only be used in combination with Tristel Clean for Stella for semi-automated cleaning.
Refer to the Safety Data Sheet of the approved disinfectant and cleaning agent prior to use.
For professional use only.

3
SECTION ONE
INTENDED USE

1
SECTION 1, INTENDED USE
The Stella System is a semi-automated washer disinfector designed specically for the disinfection of
invasive and non-invasive, heat-sensitive, non-lumened, and single-lumened medical devices.
TM
TM
TM
System B
System A
System C
Indication for Use: For the high-level disinfection of
non-lumened medical devices, such as nasendoscopes,
transoesophageal echocardiography probes, transvaginal
probes, transrectal probes, manometry catheters, and
laryngoscope blades.
Indication for Use: For the high-level disinfection of
non-lumened (see above) and single-lumened medical
devices, such as hysteroscopes, cystoscopes, intubation
endoscopes, and bronchoscopes.
Indication for Use: For the cleaning and high-level
disinfection of single-lumened and non-lumened medical
devices, such as those listed above.
PRODUCT VARIANTS

2
SECTION TWO
COMPONENTRY

3
The Small Parts Tray and Lid for
securing device accessories in the
Stella Base.
The Drainage Outlet Cap for covering outlets of
the Base during transportation. The Cap should
not be used on a full tray of disinfectant. It is for
containing disinfectant residues only.
The grommets for closing the cut-outs
when they are not being used.
Cut-outs
Overow compartment
Device compartment
Overow outlet
Cut-outs
Cut-out for the IQ
Handles
STELLA BASE
STELLA LID
ACCESSORIES
Handles
SECTION 2, COMPONENTRY
The Stella Jug for preparation of Tristel
Fuse for Stella and Tristel Clean for
Stella working solutions.
The Stella Lube, a lubricant needed for
set up and maintenance of the IQ.
The Drainage Hose for draining out
any excess liquid, after the
completed contact time.

4
STELLA PULSE
IQ Display
ON / OK button
OFF button
IQ Drainage outlet
(connect to the
Drainage Hose)
IQ Drainage inlets
(connect to the Base)
USB port and power
port behind cover.
Note: Only Stella
power adaptors
should be used,
which have an input
power of: 100-240V,
50-60Hz).
LED light indicators
ON / OFF button
Pulse lid
USB port and power
port behind cover.
STELLA IQ
Note: Only Stella
power adaptors
should be used,
which have an input
power of: 100-240V,
50-60Hz).

5
STELLA CRADLE
Connectors to Pulse unit
Tube mount
Luer Lock for connection
to a device lumen
Disinfectant pick-up / lter
Dual Luer Lock connector
(optional) for devices with
non-removable tap
PULSE TUBE SET
STELLA A STELLA B AND C

6
Components Stella A Stella B Stella C
Stella Pack 
Base (Tray) 
Lid 
Drainage Hose 
Instructions for Use 
Quick Guide Wall Chart 
Help Guide Wall Chart 
Stella IQ Pack 
Stella IQ 
Power Adaptor 
USB Cable 
Stella Pulse Pack 
Stella Pulse 
Stella Pulse Tube Set 
Power Adaptor 
Stella Cradle Pack 
Cradle 
Assembly Instructions 
Stella Cradle Shelf Pack 
Cradle Shelf 
Shelf Fixings 
Assembly Instructions 
Stella System Toolbox 
Small Parts Tray and Lid 
Stella Lube 
Grommets (2) 
Drainage Outlet Cap 
Stella Pump Hose Replacement Kit 
Surrogate Lumen Kit 
Dual Luer Lock Connector 
Stella Jug 
Manual Emergency Kit*
not available in Germany 
TABLE OF COMPONENTS

7
Stella System A: 70cm x 6cm x 23-26cm (depends on cradle levelling leg length)
Stella Systems B and C: 82cm x 46cm x 23-26cm (depends on cradle levelling leg length)
Lid: 70cm x 40cm x 4cm
Base: 64cm x 39cm x 14cm
Cradle (without Cradle Shelf): Stella A: 65cm x 46 cm x 15-18cm (depends on cradle levelling leg length)
Stella B: 80cm x 46 cm x 15-18cm (depends on cradle levelling leg length)
Drainage Hose: 6cm protruding, 100cm (tubing) + 6cm (connector) long
SPECIFICATIONS AND STORAGE
The Base and Lid can be easily stacked and transported. When empty the weight is 5.5kg.
The Drainage Outlet Cap can be used when transporting the Base to contain any small droplets of disinfectant
left in the Base.
IQ and Pulse should be operated and charged in temperatures between 10-35°C with a maximum allowable
humidity of 90%.
IQ and Pulse should be stored in temperatures between -10-40°C.
6cm
46cm
24cm
6cm
46cm
82cm

8
SECTION THREE
GETTING STARTED

9
INSTALLING THE STELLA SUITE SOFTWARE
Stella Suite is the software that allows the user to download important information or to update the rmware
relating to IQ and Pulse, and events relating to the disinfection cycle.
Windows is a supported operating System for Stella Suite. Apple is not supported.
Stella Suite software is available via https://tristel.com/stella-suite/. Please download it using a PC or Laptop
prior to using the Stella System, following the instructions on the screen.
If an update or additional components are purchased, please ensure you install the relevant rmware for your
Stella package. Refer to your local Stella Agent if you are unsure.
• Remove all components from their packaging. Ensure all components of the Stella System are clean and free of debris.
• Inspect Stella components. If missing or damaged, report to your local Stella Agent.
• Use the supplied power adaptors to charge IQ and Pulse for 12 - 16 hours before rst use.
• Install the Stella Suite Software.
SETTING UP THE STELLA SYSTEM
It is important to ensure that Stella is operated on a stable and level surface.
Otherwise, the automatic sensor that triggers the cycle will not operate reliably.
SECTION 3, GETTING STARTED
Place Stella Cradle on the surface where the Stella System will be positioned.
Adjust the feet until the bubble in the circular vial level is centred.
Stella Cradle is now ready for you to position your Stella System.
For Stella B or C, select which side of the Cradle you want the shelf. Most installations have the cradle on the
left-hand side, which is preferable, but the right-hand side is also an option.
Position the Stella Cradle Shelf under the cradle and insert the connector bolts up through the shelf to screw
them into the connector nuts.
Using the two Allen Keys hold the connector nut in place with one key, then screw in the connector bolt on the
other side with the second key. Repeat this until each of the x 4 connector bolts are in place and tightened.

10
• Remove all components from their packaging. Ensure all components of the Stella System are clean and free of debris.
• Inspect Stella components. If missing or damaged, report to your local Stella Agent.
• Use the supplied power adaptors to charge IQ and Pulse for 12 - 16 hours before rst use.
• Install the Stella Suite Software.
Firmly connect the Drainage Hose to
IQ and ensure the end of the tube is
directed into a sink or waste container.
Ensure that the end of the Drainage
Hose is in a downward position and not
immersed in the waste solution, i.e.
ensure there is an air gap.
Remove the grommet nearest to Pulse.
Attach the Tube Set to Pulse by matching
the male and female connectors. Place the
green tube mount provided rmly onto the
Base cut-out.
Ensure that the disinfectant pick-up/lter
is sitting in the inner compartment of the
Base.
The Stella System is now ready to use.
3
6
Once level, place the Base onto the
Cradle. Stand the Lid in an upright
position at the rear of the Base.
Apply the grommets into the tray
cut-outs.
Apply a little amount of Lube lubricant
onto the IQ drainage inlets. (See
Section 5 Maintenance, Lubing IQ)
Firmly attach the IQ to the Base.
Failure to ensure the correct connection
may result in a leak.
The drainage outlets from the Base
slide into the drainage inlets in the IQ.
The next two steps relate to Stella B
and C only. Place Pulse on the Cradle
Shelf.
1
4
2
5

11
SECTION FOUR
HOW TO USE

12
• Ensure the medical device has been cleaned according to the hospital standard procedures before
performing high-level disinfection with Stella System A. Tristel Clean for Stella, Tristel Pre-Clean Wipes or
Tristel Clean are recommended. Please refer to the medical device manufacturer’s care card or material
compatibility approval list.
• Disinfect hands and wear appropriate Personal Protective Equipment (PPE) when handling disinfectants
and medical devices.
• Do not attempt to move Stella whilst it is lled with solution.
Step 1
Push and hold the ON button on IQ until you hear a beep and follow the instructions shown on the
screen. IQ performs a short self-check.
Step 2
When prompted by IQ, place a clean device into the device compartment. Position the device in a way that
best ts the shape of the compartment, ensuring any connectors or non-immersible parts are placed outside
of the tray via the designated cut-outs. If the device is completely submersible, seal the cut-outs with the
grommets provided.
Devices that do not t correctly in the device compartment must not be used in the Stella System. Ensure that the Stella
lid can be completely closed.
Step 3
Any small re-usable parts from the device should be placed in the Small Parts Tray with the Lid closed and
positioned into one of the two positions available within the device compartment, t0 the left or right of IQ.
Step 4
Prepare ve litres of Tristel Fuse for Stella working solution in the Stella Jug in accordance with the user
instructions.
Step 5
When prompted by IQ pour ve litres of Tristel Fuse for Stella disinfectant into the device compartment.
It is recommended to position the Jug on the outer wall of the Base, just right of IQ, and tilt the Jug slowly, supporting
the base of the Jug with one hand. All ve litres must be added. The disinfectant will overow over the edges of the inner
compartment into the overow compartment of the Base. It will drain out immediately.
Step 6
Allow up to 10 seconds for the liquid sensor to detect the Tristel Fuse for Stella working solution in the Base.
The correct level of disinfectant automatically triggers the contact time countdown. An audible beep conrms
the start of the ve-minute disinfection cycle.
If Tristel Fuse for Stella is not added to Stella within 10 minutes,
the cycle will be automatically aborted by IQ.
Step 7
Place the Lid onto the Base, ensuring it is closed tightly. Closing the Lid will displace more disinfectant
solution into the overow compartment. IQ displays the ve-minute contact time countdown.
Do not turn off IQ during the contact time as this will lead to ineffective disinfection and the
disinfection cycle will be recorded as invalid, with no Validation Code.
SECTION 4, HOW TO USE
STELLA SYSTEM A

13
SHUTDOWN PROCEDURE FOR STELLA SYSTEM A
Turn off IQ by pressing the OFF button. You will hear a beep indicating that IQ is
switching off.
If IQ is not turned off manually within 1 minute, the backlight will dim, If not attended
within 5 minutes IQ will shut down. It is recommended to turn off IQ immediately after
use to save the battery.
After IQ has been switched off, it can be detached from the Base.
With the drainage outlet cap tted into place, the Base can be used as a
transportation unit. Wipe the unit down with a soft, low, or non-linting wipe
to remove any spills from the drain.
Step 8
After the completed contact time, Stella drains the disinfectant automatically.
The draining process may take up to one minute.
Tristel Fuse for Stella does not require rinsing, based on clinical and toxicological studies.
Step 9
When the Base is empty, you will hear a beep indicating that the cycle is complete. Press the OK button to
acknowledge that the cycle is complete. The disinfected device can now be removed for immediate use or
to be placed in storage.
Follow hospital procedures and manufacturer’s instructions for device drying and storage.
Step 10
Press the OK button again to conrm the removal of the device, prompting IQ to display a Validation Code.
This Validation Code should be noted in the Stella Quality Audit Trail Record Book or scanned by Tristel 3T
for traceability.
Failure to conrm the removal of the device will result in the IQ display backlight dimming after 5 mins.
After 10 minutes IQ will also shut down. When the unit is turned on again, the Validation Code can still be retrieved by
pressing the OK button.
A new cycle can be started by pressing the OK button again.

14
STELLA SYSTEM B
•Ensure the medical device has been cleaned according to the hospital standard procedures before per-
forming high-level disinfection with Stella System B. Tristel Clean for Stella is recommended. Please refer
to the medical device manufacturer’s care card or material compatibility approval list.
• Disinfect hands and wear appropriate Personal Protective Equipment (PPE) when handling disinfectants
and medical devices.
• Do not attempt to move Stella whilst it is lled with solution.
Step 1
Push and hold the ON button on IQ until you hear a beep. Push and hold the ON button on Pulse until you
hear a beep. IQ performs a short self-check. IQ automatically connects to Pulse and a Bluetooth sign
conrms the connection. This will remain visible throughout the operation. Follow the instructions shown
on the IQ screen.
Step 2
When prompted by IQ, place a clean device into the device compartment. Position the device in a way
that best ts the shape of the compartment, ensuring any connectors or non-immersible parts are placed
outside of the tray via the designated cut-out. If the device is completely submersible, seal the right cut-out-
with the grommet provided.
Devices that do not t correctly in the device compartment must not be used in the Stella System.
Ensure the Lid can be completely closed.
Always refer to the manufacturer’s instructions for immersion levels and guidance on how to place the
devices into the Base.
Step 3
If the device features a lumen, attach the Pulse Tube Set Luer Lock connector to the device’s lumen port and
ensure the tap is in the open position (if applicable).
Some devices have two xed ports that cannot be removed and taken apart. These two ports will feed into
the same working channel, therefore both port entries must be disinfected. To do this, use the Dual Luer
Lock connector. Connect both connectors to the xed instrument ports. Ensure both taps are in the open
position.
If the device to be disinfected does not feature a lumen, connect the Surrogate Lumen to the Pulse Tube Set.
Step 4
Any small re-usable parts from the device should be placed in the Small Parts Tray with the lid closed and
positioned into one of the two positions available within the device compartment, t0 the left or right of IQ.
Step 5
Prepare ve litres of Tristel Fuse for Stella working solution in the Stella Jug in accordance with the user
instructions.
Step 6
When prompted by IQ pour ve litres of Tristel Fuse for Stella working solution into the Device compartment.
It is recommended to position the Jug on the outer wall of the Base, just right of IQ, and tilt the Jug slowly, supporting
the base of the Jug with one hand. All ve litres must be added. The disinfectant will overow over the edges of the
inner compartment into the overow compartment of the Base. It will drain out immediately.
If Tristel Fuse for Stella is not added to Stella within 10 minutes,
the cycle will be automatically aborted by IQ.

15
Step 9
After the completed contact time Stella drains the disinfectant automatically. The draining process may take up
to one minute.
Tristel Fuse for Stella does not require rinsing, based on clinical and toxicological studies.
Step 10
When the Base is empty, you will hear a beep indicating that the cycle is complete. Press the OK button to
acknowledge that the cycle is complete. The disinfected device can now be removed for immediate use or to be
placed in storage.
Follow hospital procedures and manufacturer’s instructions for device drying and storage.
Step 11
Press the OK button again to conrm the removal of the device, prompting IQ to display a Validation Code.
This Validation Code should be noted in the Stella Quality Audit Trail Record Book or scanned by Tristel 3T for
traceability.
Failure to conrm the removal of the device will result in the IQ display backlight dimming after 5 mins, and Pulse will
shut down. After 10 minutes IQ will also shut down. When the unit is turned on again, the Validation Code can still be
retrieved by pressing the OK button.
A new cycle can be started by pressing the OK button again.
Turn off IQ by pressing the OFF button. You will hear a beep indicating that IQ is
switching off. When IQ is turned off, Pulse will switch off automatically.
If IQ is not turned off manually within 1 minute the backlight will dim, if not attended with
in 5 minutes the IQ and Pulse will shut down. It is recommended to turn off IQ immediately
after use to save the battery.
After IQ has been switched off, it can be detached from the Base.
With the drainage outlet cap tted into place, the Base can be used as a transportation unit.
Wipe the unit down with a soft, low or non-linting wipe to remove any drops or spills from the drain.
SHUTDOWN PROCEDURE STELLA SYSTEM B
Step 7
Allow up to 10 seconds for the liquid sensor to detect the Tristel Fuse for Stella working solution in the Base. The
correct level of disinfectant automatically triggers the contact time countdown. An audible beep conrms the
start of the disinfection cycle.
Step 8
Place the Lid onto the Base, ensuring it is closed tightly. Closing the Lid will displace more disinfectant solution
into the overow compartment. At the beginning, the Pulse pumps the disinfectant through the device channel
for 1 minute. The system then rests until the ve-minute contact time has passed. IQ displays the contact time
remaining. At the end, Pulse pumps disinfectant solution through the device channel again.
Do not turn off IQ during the contact time as this will lead to ineffective disinfection
and the disinfection cycle will be recorded as invalid, with no validation code.

16
• Ensure the medical device has been pre-cleaned according to the hospital standard procedures before
performing cleaning and high-level disinfection with Stella System C. Tristel Clean for Stella is recommended.
Please refer to the medical device manufacturer’s care card or material compatibility approval list.
•Disinfect hands and wear appropriate Personal Protective Equipment (PPE) when handling disinfectants and
medical devices.
• Do not attempt to move Stella whilst it is lled with solution.
Step 1
Push and hold the ON button on IQ until you hear a beep Push and hold the ON button on Pulse until you hear
a beep. IQ performs a short self-check. IQ automatically connects to Pulse and a Bluetooth sign conrms the
connection. This will remain visible throughout the operation. Follow the instructions shown on the IQ screen.
Step 2
When prompted by IQ, place the manually pre-cleaned device into the Device compartment. Position the
device in a way that best ts the shape of the compartment, ensuring any connectors or non-immersible
parts are placed outside of the tray via the designated cut-out. If the device is completely submersible,
seal the cut-out with the grommet provided.
Devices that do not t correctly in the Device compartment must not be used in the Stella System.
Ensure the Stella lid can be completely closed.
Always refer to the manufacturer’s instructions for immersion levels and guidance on how to place the devices into the
Base.
Step 3
If the device to be cleaned/disinfected features a lumen, attach the Pulse Tube Set Luer Lock connector to
the device’s lumen port and ensure the tap is in the open position (if applicable).
Some devices have two xed ports that cannot be removed and taken apart. These two ports will feed into
the same working channel, therefore both port entries must be disinfected. To do this, use the Dual Luer Lock
connector. Connect both connectors to the xed instrument ports. Ensure both taps are in the open position.
If the device to be cleaned/disinfected does not feature a lumen, connect the Surrogate Lumen to the Pulse
Tube Set.
Step 4
Any small re-usable parts from the device should be placed in the Small Parts Tray with the lid closedand
positioned into one of the two positions available within the Device compartment, to the left or right of IQ.
Step 5
Prepare ve litres of Tristel Clean for Stella working solution in the Stella Jug in accordance with the user
instructions.
Step 6
When prompted by IQ pour ve litres of Tristel Clean for Stella working solution into the Base inner
compartment.
It is recommended to position the Jug on the outer wall of the Base, just right of the IQ, and tilt the Jug slowly,
supporting the base of the Jug with one hand. All ve litres must be added. The detergent solution will overow over the
edges of the inner compartment into the overow compartment of the Base.
It will drain out immediately.
STELLA SYSTEM C

17
If Tristel Fuse for Stella is not added to Stella within 10 minutes,
the cycle will be automatically aborted by IQ.
Do not turn off IQ during the contact time as this will lead to ineffective disinfection and the
disinfection cycle will be recorded as invalid, with no validation code.
Step 11
Allow up to 10 seconds for the liquid sensor to detect the Tristel Fuse for Stella working solution in the Base.
The correct level of disinfectant automatically triggers the contact time count down. An audible beep conrms
the start of the ve-minute disinfection cycle.
Step 12
Place the Lid onto the Base ensuring it is closed tightly. Closing the Lid will displace more disinfectant solution
into the overow compartment. IQ displays the ve-minute contact time countdown.
Step 7
Place the lid onto the Base ensuring it is closed tightly. Closing the lid will displace more detergent solution
into the Base overow compartment. IQ displays the ve-minute contact time countdown.
Step 8
After the completed contact time Stella drains the detergent solution automatically. The draining process
may take up to one minute.
If a disinfection cycle does not follow within 15 minutes IQ will go to sleep to maintain battery life. If a disinfection cycle
does not follow within 30 minutes the cycle will be automatically aborted by IQ, a new cleaning cycle must be started.
If any visible residual soiling remains in the Stella Base following the cleaning cycle, this should be removed
with a water-wetted, soft, low or non-linting wipe.
Step 9
Prepare ve litres of Tristel Fuse for Stella working solution in the Stella Jug in accordance with the user
instructions.
Step 10
When prompted by IQ pour ve litres of Tristel Fuse for Stella working solution into the Base inner
compartment.
It is recommended to position the jug on the outer wall of the Base, just right of the IQ, and tilt the jug slowly,
supporting the base of the jug with one hand. The disinfectant solution will overow over the edges of the inner
compartment into the overow compartment of the Base. It will drain out immediately.
Step 13
After the completed contact time Stella drains the disinfectant automatically. The draining process may take
up to one minute.
Tristel Fuse for Stella does not require rinsing, based on clinical and toxicological studies.
Step 14
When the Base is empty, you will hear a beep indicating that the cycle is complete. Press the OK button to
acknowledge that the cycle is complete. The disinfected device can now be removed for immediate use or
to be placed in storage.
Follow hospital procedures and manufacturer’s instructions for device drying and storage.