System

USER GUIDE

1
2
CONTENTS
SECTION 1
INTRODUCTION PAGE NO.
Intended Purpose and Performance 1
Components and Stella Footprint 2 - 5
Disinfectants and Medical Devices for Use with Stella 6
Preparing the Stella System for First Use 6
Installing the Stella Suite Download Software 6

SECTION 2 THE STELLA SYSTEM: OPERATING PROCEDURE 8 - 12

SECTION 3 THE STELLA PULSE SYSTEM: OPERATING PROCEDURE 14 - 20
SECTION 4 MANUAL PRE-CLEANING, STELLA CLEANING & DISINFECTING 22 - 26
OPERATING PROCEDURE
SECTION 5
MAINTENANCE 28 - 36
Bluetooth Paring Process 28
Stella IQ Lubing Process 29
Pump Hose Change Process 29 - 30
Battery indicators and Charging Protocol 31 - 32
Downloading the Information 33 - 34
Cleaning, Disinfection and Sterilisation of Stella, IQ and Pulse 35
Storage and Operating Conditions 36
Disposal Considerations 36

SECTION 6 TROUBLESHOOTING GUIDE AND GLOSSARY 38 - 46

Troubleshooting Guide and Frequently Asked Questions 38 - 46
Glossary of Graphical Symbols Used on the Stella System 46

SECTION 7
REGULATORY AND WARRANTY INFORMATION 49 - 57
Warranty for Stella IQ and Stella Pulse 49 - 51
Regulatory Information 51 - 57
Manufacturer 57

SECTION 8
STELLA SERVICE AGENTS 58 - 59

The Operating Instructions in this manual outline general safety guidelines for the correct operation of Stella System
(hereinafter referred to as Stella), Stella IQ (hereinafter referred to as IQ), Stella Pulse (hereinafter referred to as Pulse)
and Stella Cradle (hereinafter referred to as Cradle).

Carefully read and understand the user instructions before attempting to operate Stella, IQ or Pulse.

Never use Stella, IQ, Pulse or Cradle for any purpose other than the Intended Purpose.

Refer to the Safety Data Sheet of the approved disinfectant product to be used prior to use.

Should the unit(s) appear to malfunction, download the data and observe the LCD graphic messages.
This will allow you to take appropriate corrective action or to arrange for repair.
All repairs must be carried out by an approved and qualified service technician.
Do not use the Stella, IQ, Pulse or Cradle, including the IQ or Pulse power adaptors,
if they have been damaged or have changed in performance.

Ensure the instrument for disinfection is compatible with the Stella System prior to use.

For professional use only.

 SECTION ONE
INTRODUCTION

4
 Introduction
SECTION 1: INTRODUCTION
Stella is an automated system designed specifically for the disinfection of heat-sensitive small and medium-sized,
rigid and flexible, non-lumened and single-lumened endoscopes used in Urology, Gynaecology, IVF, Cardiology,
ENT, Anesthesiology and Respiratory. Stella combines the simplicity of manual soaking with the sophistication
of a fully automated washer disinfector. There are three Stella options available, which are outlined below.

TM

System A
The Stella System provides a five minute turnaround
of instruments. It records electronic validation information

PRODUCT CODE: STELLA A

which can be downloaded to software for traceability.
Indication for Use: For the high-level disinfection of
non-lumened medical devices, such as transoesophageal
echocardiographic probes, transvaginal probes, transrectal
probes, manometry catheters and laryngoscope blades.
Components: Stella Pack, Stella IQ Pack, Stella Cradle Pack,
Stella Cradle Shelf Pack and Stella Toolbox.

TM

System B
The Stella with Pulse System provides all the benefits of
the Stella System whilst additionally confirming instrument
PRODUCT CODE: STELLA B

connection and determining blocked instruments,

protecting them from over-pressure.
Indication for Use: For the high-level disinfection of
non-lumened (see Stella System) and single-lumened
medical devices, such as hysteroscopes, cystoscopes,
nasendoscopes, intubation endoscopes and bronchoscopes.
Components: Stella Pack, Stella IQ Pack, Stella Cradle Pack,
Stella Cradle Shelf Pack, Stella Toolbox and Stella Pulse Pack.

TM

System C

The Stella with Pulse & Cleaning System provides all the
benefits of the Stella with Pulse System, plus a cleaning cycle.
PRODUCT CODE: STELLA C

It has a ten minute turn around of instruments; five minutes

for automated cleaning and five minutes for automated
high-level disinfection.
Indication for Use: For the cleaning and high-level
disinfection of single-lumened and non-lumened medical
devices, such as those listed above.
Components: Stella Pack, Stella IQ Pack, Stella Cradle Pack,
Stella Cradle Shelf Pack, Stella Toolbox and Stella Pulse Pack.

*All Stella systems exclude consumables, which are ordered separately.

1
 TRISTEL FUSE FOR STELLA CHEMISTRY
Tristel Fuse for Stella is a single-use disinfectant solution designed specifically for use in Stella for the
high-level disinfection of semi-critical medical devices.
Tristel Fuse for Stella incorporates two separate compartments that contain 50ml Tristel Base solution
(citric acid) and 50ml Tristel Activator solution (sodium chlorite). When mixed upon bursting the sachet,
Tristel’s proprietary chlorine dioxide chemistry is generated for dilution into five litres of water.
The Stella System provides chemistry detection based on conductive measurements of the Tristel Fuse
for Stella working solution. Ambient temperature tap water should be used for the working solution.
Very hard water and reverse osmosis (RO) water can affect the conductivity function.

COMPONENTRY CONTENTS
STELLA PACK CONTAINS: STELLA IQ PACK CONTAINS:
• Base • Stella IQ
• Lid • Power adaptor
• Drainage hose set • USB Cable
• Small Parts Tray and lid
• 2 grommets STELLA PULSE PACK CONTAINS:
• Stella Lube
• Stella Pulse unit
• Drainage outlet cap
• Stella Pulse tube set
• Instructions for Use
• Power adaptor
• Stella Jug (packed separately)
• Surrogate lumen

STELLA CRADLE PACK CONTAINS: STELLA CRADLE SHELF PACK CONTAINS:

• Cradle with fill cap and Cradle feet
• Cradle Shelf
• Assembly Instructions
• Shelf Fixings
• Assembly Instructions
STELLA TOOLBOX CONTAINS:
• Stella Manual Emergency Kit
• Pump Hose Replacement Process Kit
• Stella Suite Installation Card
Also included in the toolbox
for Pulse systems only are;
• Surrogate Lumen Kit
• Double Luer Lock Connector Kit

2
 Introduction
STELLA BASE

Location for lid

Cut-outs (both sides)

Overflow compartment

Instrument compartment

Overflow outlet
Handles (both sides) Drain outlet

STELLA LID

Cut-outs (both sides)

Handles (both sides) Cut-out for the IQ

ACCESSORIES

Small Parts Tray and Lid for securing Drainage Outlet Cap for covering outlets of the Base
instruments’ accessories in the Stella during transportation. The Cap should not be used
Base. on a full tray of disinfectant. It is for containing
disinfectant residues only.

Stella Lube should be applied to

Stella IQ before first use then every 6 The grommets close the cut-outs when they are not
months in order to ensure a firm fit of being used.
the IQ to the base.

3
STELLA IQ

Display USB port and

OFF button power port behind
ON / OK button cover (Input power
requirements:
100-240V, 50-60Hz)

IQ Drain inlets
(connect to
Drain outlet Stella base)

STELLA PULSE

Lid ON / OFF button

LED light indicators

USB port and power

port behind cover
(Input power
requirements:
100-240V, 50-60Hz)

PULSE TUBE SET

Luer lock for connection

to lumen

Tube mount

Dual luer lock connector

(optional) for instruments
with non-removable tap

Disinfectant pick-up / filter

Connectors to Pulse unit

4
 Introduction
STELLA CRADLE

Once Stella Cradle is positioned for use, adjust the feet using the spirit level. It is important to ensure that
the Stella is operated on a stable and level surface. Otherwise, the automatic sensor that triggers the cycle
will not operate reliably.

STELLA FOOTPRINT
The Stella System measures
70cm x 46cm.
The Stella with Pulse System
measures 81cm x 46cm.
The height of the Stella and Stella
with Pulse System is variable
depending on the adjustment of
Cradle Feet, but on average when
holding the Stella Base and lid
measures 23cm.
The Stella Base and Lid can be
stacked and easily transported
due to their portable size and
weight. When empty, the weight
is 5.5kg.

5
 DISINFECTANTS AND MEDICAL DEVICES FOR USE WITH STELLA
Tristel Fuse for Stella is a single-use disinfectant solution designed specifically for use in Stella
for the high-level disinfection of semi-critical medical devices.
Tristel Fuse for Stella incorporates two separate compartments that contain 50ml Tristel Base solution
(citric acid) and 50ml Tristel Activator solution (sodium chlorite). When mixed upon bursting the sachet,
Tristel’s proprietary chlorine dioxide chemistry is generated for dilution into five litres of water.
The Stella System provides chemistry detection based on conductive measurements of the Tristel Fuse
for Stella working solution. Ambient temperature tap water should be used for the working solution.
Very hard water and reverse osmosis (RO) water can affect the conductivity function.
The Stella IQ ensures that a medical device is in contact with Tristel Fuse for Stella for 5 minutes only.
The disinfectant is then automatically drained to waste. Tristel Fuse for Stella is a single-use disinfectant
and must not be re-used. The disinfectant should be disposed of in accordance with the user instructions
and Safety Data Sheets provided by the manufacturer.
The Stella System is intended for the decontamination of non- and single-lumened medical devices.
Follow the medical device manufacturers’ guidance for recommended reprocessing of the device.

PREPARING THE STELLA SYSTEM FOR FIRST USE

• Remove all components from their packaging.
• Inspect components for damage. If damaged, report to your local Stella Service Agent.
• Use the supplied power adaptors to charge the IQ and Pulse for 12 - 16 hours.
Refer to the Maintenance section of this manual for charging instructions.
• Apply Stella Lube (silicone lubricant) to Stella IQ drainage inlets before attaching
onto the Stella Base using the following instructions:

1 Wearing gloves apply a small amount of Stella Lube to the outside perimeter of each
of the drainage inlets (spread the lubricant evenly around the surface of the inlets).
DO NOT apply lubricant to the IQ drain outlet onto which the drain hose is attached.
2 Wash your hands carefully after applying the lubricant.

From time to time the lubricant may need to be re-applied to the drainage inlets of Stella IQ to ensure the firm
fit of IQ to the Base. For video instructions visit the help section on www.stella-performance.com.

INSTALLING THE STELLA SUITE SOFTWARE

Stella Suite is the software that allows the user to download important information relating to the Stella IQ
and Pulse, and events relating to the disinfection cycle. This information can be downloaded onto compatible
equipment such as a PC or laptop for storage and printing. Using a laptop or PC, install the Stella Suite and
follow the instructions on screen.

Stella software is available via the Stella website www.stella-performance.com. If an update or additional
components are purchased, please ensure you install the relevant software for your Stella package.
Refer to your local Stella agent if you are unsure.

6
SECTION TWO
STELLA OPERATING PROCEDURE

7
SECTION 2: THE STELLA SYSTEM: OPERATING PROCEDURE

SET-UP PROCEDURE
This section covers the set-up and operating procedures of the Stella System.
For instructions on using Stella Pulse System please refer to Section 3.
Ensure all components of the Stella System are clean and free of debris.
Assemble the Cradle in accordance with the instructions provided and as demonstrated
in the Introduction section. Once level, place the Stella Base onto the Cradle.

Parts of the instrument may not be effectively immersed in the disinfectant if the Base is not placed level.
It is important to ensure that the Stella is operated on a stable and level surface. Otherwise, the automatic
sensor that triggers the cycle will not operate reliably.

Choose a position for Stella where leaks, splashes or spills of disinfectant will not cause damage to
surrounding surfaces or materials.

Stand the Lid in an upright position at the rear of the Base,

in its secure place within the overflow compartment.

Firmly attach the IQ to the Base.

The drain outlets from the Base slide into the drain inlets in the IQ.

Ensure the IQ is firmly attached to the Base.

Failure to ensure correct connection may result in a leak.

Firmly connect the drain tube to the IQ and ensure the end of the tube is
directed into a sink or waste container. Ensure that the end of the drain
tube is not immersed into the waste solution, i.e. there is an air gap.

The drain tube must be in a downward position to ensure free water flow.

Pre-clean all instruments and devices before disinfecting them in Stella.

See section 4 for manual cleaning, leak test the device if applicable.

Follow the medical device manufacturers’ guidance.

8
ILLUSTRATION DESCRIPTION IQ REFERENCE

Push the ‘ON’ button on the IQ until you hear a

sound and follow the instructions shown on the
screen.

STELLA OPERATING PROCEDURE

The IQ performs a short self-check. It then asks
to add the pre-cleaned instrument.
Place the pre-cleaned instrument into Stella’s
instrument compartment.
Position the instrument in a way that best fits the
shape of the compartment, making sure all parts
fit easily below the top edge of the inner wall.

Instruments that do not fit correctly in the instrument compartment must not be used in Stella.

Any cables and parts of the instrument that cannot

be immersed, should exit Stella through the
designated cut-outs in the side walls.

If the instrument is completely submersible, seal

the cut-outs with the grommets provided.
Any small removable parts from the instrument
requiring disinfection should be placed in the
Small Parts Tray and closed with its lid.
There are two positions in the instrument
compartment where the Small Parts Tray and lid
are best positioned, one to the left and one to
the right of the IQ.
When the instrument is correctly placed into the
instrument compartment, make up five litres of
Tristel Fuse for Stella disinfectant solution.
Tristel Fuse for Stella should be prepared
and used at room temperature.

Follow the Fuse for Stella instructions for use, and refer to the Safety Data Sheet.

9
ILLUSTRATION DESCRIPTION IQ REFERENCE
When prompted by the IQ, carefully and steadily
pour Tristel Fuse for Stella disinfectant into the
inner instrument 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.
Fill the instrument compartment of the Base
with the full five litres of Tristel Fuse for Stella
Disinfectant.
The disinfectant will overflow over the edges of the
inner compartment into the overflow compartment
of the Base. It will drain out immediately.

Pour the disinfectant carefully to avoid or minimise splashes.

Refer to the disinfectant Safety Data Sheet for Spillage Procedures.

Failure to fill the instrument compartment with the full five litres will result in the cycle not commencing.
If the correct level of liquid is not detected within 10 minutes, the Stella IQ will abort the procedure.

Do not move Stella whilst it is filled with liquid.

The correct level of disinfectant automatically

triggers the contact time count down. Allow up
to 10 seconds for the liquid sensor to detect the
liquid in the Base.
An audible beep confirms the start of the
disinfection cycle.

If Stella is not positioned on a level surface, then the disinfection cycle will not automatically trigger as
Stella’s liquid sensor will not detect the correct level of disinfectant.

Please check the Stella IQ display for the disinfection symbol. On rare occasions, the cycle may have to be start-
ed manually. In this case, Stella IQ will ask you to press the ‘ON’ button as indicated on the display.

10
ILLUSTRATION DESCRIPTION IQ REFERENCE

STELLA OPERATING PROCEDURE

Place the Lid onto the Base. Ensure it is closed
tightly. Closing the Lid will displace more
disinfectant solution into the overflow
compartment. The IQ displays the countdown
of disinfection time (contact time).

Do not turn the IQ off during the contact time as this will lead to ineffective disinfection of the instrument and
draining of the solution from the Base. A manual interruption of the disinfection cycle will be recorded into the
data log report produced in Stella Suite and no validation code will be presented.

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.

Follow medical device manufacturers’ guidance for any rinsing, drying and storage.

When the Base is empty, there is an audible

reminder that the cycle is complete.

To acknowledge the completion of the cycle,

press the ‘ON’ button.
The disinfected instrument can now be removed
for immediate use or placed in sterile storage.

Failure to confirm the removal of the instrument will result in the IQ display backlight shutting down
after 15 minutes to maintain battery life. The audible beep is also turned off at this stage. If after 30
minutes ‘Confirm Removal of Instrument’ has not been confirmed, Stella IQ will shut down. When
the unit is turned on again, the ‘Confirm Removal of Instrument’ instruction remains, allowing the
user to confirm by pressing the ‘OK’ button which will retrieve the Validation Code.

11
ILLUSTRATION DESCRIPTION IQ REFERENCE

Upon pressing the ‘ON’ button, a Validation Code

is displayed.
This Validation Code should be noted in the
Stella Quality Audit Trail Book.

SHUTDOWN PROCEDURE
ILLUSTRATION DESCRIPTION IQ REFERENCE
A new cycle can immediately be started by
pressing the ‘OK’ button again.
Alternatively, turn off the IQ by pressing the ‘OFF’
button. There is a sound to indicate that the IQ is
switching off. If the IQ is not turned off manually,
it will automatically shut down after 15 minutes to
save the battery.
After the Stella IQ has been switched off, it can be
detached from the Stella Base. The Base can be
used as a transportation unit. Fitting the drainage
outlet cap prevents small liquid spills.

Wipe the unit with a paper towel to remove any drops or spills from the drain.

12
SECTION THREE
PULSE OPERATING PROCEDURE

13
SECTION 3: PULSE OPERATING PROCEDURE
SET-UP PROCEDURE
This section covers the set-up and operating procedures of the Stella Pulse System. For instructions on
using Stella System please refer to Section 2.
Ensure all components of the Stella Pulse System are clean and free of debris. Assemble the Cradle in
accordance with the instructions provided and as demonstrated in the Introduction section. Once level,
place the Stella Base onto the Cradle.

Parts of the instrument may not be effectively immersed in the disinfectant if the Base is not placed level. It is
important to ensure that the Stella is operated on a stable and level surface. Otherwise, the automatic sensor
that triggers the cycle will not operate reliably.

Choose a position for Stella where leaks, splashes or spillages of disinfectant will not cause damage to
surrounding surfaces or materials.

Stand the Lid in an upright position at the rear of the Base, in its secure place
within the overflow compartment.

Firmly attach the IQ to the Base. The drain outlets from the Base slide into the
drain inlets in the IQ.

Ensure the IQ is firmly attached to the Base.

Failure to ensure correct connection may result in a leak.

Firmly connect the drain tube to the IQ and ensure the end of the tube is
directed into a sink or waste container. Ensure that the end of the drain tube
is not immersed into the waste solution, i.e. there is an air gap.

The drain tube must be in a downward position to ensure free water flow.

Place Pulse on the Cradle Shelf. Remove the grommet from the left cut-out of the Base.

14
Attach Pulse tube set to Pulse by matching the male and female connectors.
Place the green tube mount provided with Pulse tubing firmly onto the cut-out.
Ensure that the disinfectant pick-up / filter is sitting in the inner compartment.

Pre-clean all instruments and devices before disinfecting them in Stella.

See section 4 for manual cleaning, leak test the device if applicable.

PULSE OPERATING PROCEDURE

Follow the medical device manufacturers’ guidance.

Connect the luer lock connector to the instrument when it is placed in the
inner compartment.

If the instrument is not equipped with a compatible fitting, please contact the scope
manufacturer/distributor to obtain an adaptor.

When using the Stella Pulse System with a non-lumened instrument, please attach the supplied surrogate lumen
to Pulse tube set. Ensure the surrogate lumen is placed within the inner compartment next to the instrument.

Every 1000 disinfection cycles, the Stella Pulse Pump must be changed. Cycles are counted in the Stella Suite Report.

15
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION
Push the ‘ON’ button on the Push the ‘ON’ button on
IQ until you hear a sound and Pulse until you hear a sound.
follow the instructions shown
The LED top light will glow
on the screen.
solid green to show that it is
In the background, the IQ turned on.
performs a short self-check.
In the background, Pulse
IQ automatically connects to performs a short self-check.
Pulse.
The blue LED will flash whilst
The IQ and Pulse are paired. it is establishing a Bluetooth
The Bluetooth sign confirms connection.
the connection and remains on
When a connection is
throughout operation.
established the LED will
The IQ asks to add the glow solid blue.
pre-cleaned instrument into
The green LED will start
Stella’s instrument
flashing to indicate the
compartment.
automatic pump control is
Place the cleaned instrument on standby.
into Stella’s inner instrument
compartment. Position the
instrument in a way that
best fits the shape of the
compartment making sure all
parts fit easily below the top
edge of the instrument
compartment’s wall.

Instruments that do not fit correctly in the instrument compartment must not be used in Stella.

Ensure that the disinfectant pick-up / filter is sitting in the instrument compartment.

Connect the luer lock connector

to the instrument’s channel.

Any cables and parts of the

instrument that cannot be
submerged should exit Stella
through the right cut-out. If
the instrument is completely
submersible, seal the cut-out
with the grommets provided.

16
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION
Any small removable parts from
the instrument that are
submersible should be placed in
the Small Parts Tray with the lid
firmly closed.
There are two positions within
the instrument compartment
where the Small Parts Tray is best

PULSE OPERATING PROCEDURE

positioned, one to the left and
one to the right of the IQ.
When the instrument is
properly placed into the
instrument compartment and
connected to Pulse make up
five litres of Tristel Fuse for
Stella disinfectant solution.
Tristel Fuse for Stella should
be prepared and used at room
temperature.

Follow the Fuse for Stella instructions for use and refer to the Safety Data Sheet.

When prompted by the IQ,

add Tristel Fuse for Stella
disinfectant into Stella.

Carefully and steadily pour

the disinfectant into the inner
instrument compartment.
To avoid having to lift the five
litre jug, it is recommended to
position it on the outer wall
of the base to the right of the
IQ and tilt the jug slowly. The
liquid pours slowly and
steadily into the instrument
compartment.
Fill the instrument
compartment in the Base with
the full 5 litres of Tristel Fuse for
Stella disinfectant. The
liquid will overflow over into the
overflow compartment.

17
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION

Pour the disinfectant carefully to avoid or minimise splashes.

Refer to the disinfectant Safety Data Sheet for Spillage Procedures.

Failure to fill the instrument compartment with the full 5 litres will result in the cycle not commencing.
If the correct level of liquid is not detected within 10 minutes, the Stella IQ will abort the procedure.

Do not move Stella whilst it is filled with liquid.

Ensure the disinfectant pick-up / filter is fully submerged.

The level of the disinfectant

solution automatically
triggers the disinfection cycle
and contact time countdown.
Allow up to ten seconds for
the liquid sensor to detect the
liquid in the Base.
A sound confirms the start of
the disinfection cycle.

Please check the Stella IQ display for the disinfection symbol. On rare occasions the cycle may have to be
started manually. In this case Stella IQ will ask you to press the ‘ON’ button as indicated on the display.

Stella Pulse has a fluid detection system that detects the presence of the Fuse for Stella disinfectant.
If water is added without disinfectant, a failure code 119 will be displayed on the LCD screen, the cycle
will fail and drain the water from Stella. This detection will occur in the first 30 seconds of the cycle.

If the instrument is not attached to the Stella Pulse tube set, a fail notification graphic and sound alternating
with a message reporting ‘instrument unhooked’ will be displayed. If the instrument is not connected within
30 seconds Stella will drain the disinfectant and report an incomplete cycle.

18
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION

Fit the Lid onto the Base. The At the start of the
IQ displays the countdown of disinfection cycle, Pulse will
the remaining disinfection time start pumping the disinfectant
(contact time). through the channel of the
instrument for one minute
The animated arrow in the LCD
and then pause to hold the
graphic confirms that Pulse is
disinfectant within the
pumping. When the pump stops
channel. This is indicated by
the animated arrow

PULSE OPERATING PROCEDURE

the solid green LED light.
remains stationary.
When Pulse stops, the green
LED light flashes momentarily
indicating standby.

Do not turn the IQ off during the contact time as this will lead to ineffective disinfection of the instrument and
draining of the solution from the Base. A manual interruption of the disinfection cycle will be recorded into the
data log report produced in Stella Suite and no validation code will be presented.

After the contact time Stella After 40 seconds of Stella

automatically drains the draining, Pulse pumps air
disinfectant from the Base. through the instrument’s
The animated arrow in the channel to remove
LCD graphic confirms that residual disinfectant.
Pulse is operating. The draining This may take up to one
process may take up to one minute. This is indicated by
minute. Tristel Fuse for Stella the solid green LED light.
does not require any rinsing.
When the Stella is empty there
is an audible reminder that the
cycle is complete.

If the instrument becomes detached from the Stella Pulse tube set during the disinfection cycle, a fail
notification graphic and sound, alternating with a message reporting ‘instrument unhooked’ will be
displayed at the end of the disinfection cycle. An incomplete cycle will be reported and the disinfection
cycle must be repeated.

Follow medical device manufacturers’ guidance for any rinsing, drying and storage.

19
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION

The IQ display confirms that the

disinfection cycle is
complete. It asks to Pulse returns to Standby
confirm that the disinfected which is indicated by the
instrument will be removed flashing green LED light.
for immediate use or to (sterile)
storage. Confirm by pressing the
‘OK’ button.

Upon pressing the ‘OK’ button,

a validation code is displayed.
This validation code should be
noted in the traceability book If a new cycle is started, Pulse
for future reference. follows the instruction from
the Stella IQ. The disinfection
The IQ asks if a new cycle
cycle starts from the
should be started and prompts
beginning.
the user to press the ‘OK’
button. A new cycle can
immediately be started by
pressing the ‘OK’ button again.

Failure to confirm removal of the instrument will result in the LCD backlight shutting down after 15 minutes to
maintain battery life. The audible beep is also turned off at this stage. If after 30 minutes ‘confirm removal of
instrument’ has not been confirmed, Stella IQ will shut down. When the unit is turned on again, the ‘confirm
removal of instrument’ instruction remains allowing the user to confirm by pressing the ‘OK’ button, which
will retrieve the validation code.

SHUTDOWN PROCEDURE

Turn off the IQ by pressing the

OFF button. There is a sound to If the IQ is turned off, Pulse
indicate that the IQ and Pulse will switch off automatically.
are switching off.

20
SECTION FOUR
MANUAL PRE-CLEANING, STELLA CLEANING &
DISINFECTION OPERATING PROCEDURE

21
SECTION 4: MANUAL PRE-CLEANING, STELLA CLEANING
& DISINFECTION OPERATING PROCEDURE
Always follow medical device manufacturers’ guidance for correct handling of the device during the
decontamination cycle.

MANUAL PRE-CLEANING
1. Remove any visible soil and excess water from the medical device.
2. Prepare 25ml of Tristel Clean for Stella by squeezing the bottle until the marking on the cap is
reached. Pour the 25ml concentrate into five litres of cold water.
3. Immerse the instrument in the Tristel Clean for Stella and ensure a five minute contact time.
4. In the case of a lumened instrument, thoroughly brush the channel with the Tristel Clean for Stella,
following hospital approved protocols.
5. Remove the instrument from the Tristel Clean for Stella and remove excess liquid.
6. Place the instrument in the Stella System. Follow the instructions on the display.
7. Discard the Tristel Clean for Stella after each use.

Pour the disinfectant carefully to avoid or minimise splashes.

Refer to the disinfectant Safety Data Sheet for Spillage Procedures.

If a detergent other than Tristel Clean for Stella is used,

rinse the medical device prior to placement in the Stella System.

AUTOMATED CLEANING IN STELLA

Tristel Clean for Stella must be used. Use of other detergents must be approved by Tristel.
Unsolicited use of other detergents may affect the efficacy of the disinfectant.

STELLA IQ: STELLA PULSE:

ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION
Push the ‘ON’ button on the Push the ‘ON’ button on Pulse
IQ until you hear a sound until you hear a sound. The
and follow the instructions LED light will glow solid green
shown on the screen. In to show that it is turned on.
the background, the IQ In the background, Pulse
performs a short self-check. performs a short self-check.
IQ automatically connects to The blue LED will flash whilst
Pulse. it is establishing a Bluetooth
The IQ and Pulse are paired. connection.
The Bluetooth sign confirms When a connection is
the connection and remains established the LED will
on throughout operation. glow solid blue. The green
The IQ asks to add the LED will start flashing to
‘pre-cleaned instrument’ indicate the automatic pump
into Stella’s instrument control is on standby.
compartment.

22
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION

Connect the luer lock connector

to the instrument channel.

Any small removable parts from

the instrument that are
submersible should be placed
in the Small Parts Tray with the
lid firmly closed.
There are two positions within the
instrument compartment where
the Small Parts Tray is best

MANUAL PRE-CLEANING, STELLA

positioned, one to the left and one

CLEANING & DISINFECTING

OPERATING PROCEDURE
to the right of the IQ.
When the instrument is properly
placed into the instrument
compartment and connected to
Pulse make up five litres of Tristel
Clean for Stella.

Follow the Clean for Stella instructions for use, and refer to the Safety Data Sheet.

When prompted by the IQ, add

diluted Tristel Clean for Stella.

Carefully and steadily pour 5 litres When the full 5 litres of

of Tristel Clean for Stella into the Tristel Clean for Stella is
inner compartment. To avoid added, the cleaning cycle
having to lift the five litre jug, it will automatically start.
is recommended to position it The following features will
on the outer wall of the base to be monitored;
the right of the IQ and tilt the jug
• Stella will detect if the
slowly. The liquid pours slowly
instrument is connected at
and steadily into the instrument
the beginning of the clean
compartment.
cycle and at the end.
Fill the instrument compartment in • Stella will detect if the
the Base with the full five litres of instrument has a blockage.
Tristel Clean for Stella. The liquid • Stella will detect if cleaning
will overflow over into the solution vs water is added.
overflow compartment.

23
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION

Fit the Lid onto the Base. At the start of the cleaning
The IQ displays the countdown cycle, Pulse will start
of the remaining cleaning cycle pumping the solution through
(contact time five mins). The the channel of the instrument
animated arrow in the LCD graphic for one minute and then
confirms that Pulse is pumping. pause to hold the solution
within the channel. This is
When the pump stops the indicated by the solid green
animated arrow remains LED light.
stationary (wheel segments
will need to be have time split When Pulse stops, the green
reallocated). LED light flashes momentarily
indicating standby.

After the Tristel Clean for After 40 seconds of Stella

Stella contact time, Stella draining, Pulse pumps air
automatically drains the through the instrument’s
solution from the Base. channel to remove residual
The animated arrow in the Tristel Clean for Stella.
LCD graphic confirms that This may take up to one
Pulse is operating. The minute. This is indicated by
draining process may the solid green LED light.
take up to one minute.
When Stella is empty and ready
for the disinfection
cycle an audible reminder
will sound. If the disinfection
cycle does not follow within
15 minutes, the backlight on
Stella IQ LCD will shut down
to maintain battery life. The
audible reminder will also be
turned off at this stage.
If after 30 minutes the
disinfection cycle has not been
started, Stella IQ and Stella
Pulse will shut down. When
the IQ and Pulse units are
turned on again, the
complete cleaning and
disinfection cycle must be
re-started.

24
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION

The Stella Disinfection Cycle When the full 5 litres of Tristel

is ready to start. Make up 5 Fuse for Stella is added,
litres of Tristel Fuse for Stella the disinfection cycle will
disinfectant. Carefully and automatically start.
steadily pour the disinfectant into
The following features will be
the inner instrument
monitored;
compartment.
• Stella will detect if the
To avoid having to lift the five litre
instrument is connected
jug, it is recommended to position
at the beginning of the
it on the outer wall of the base to
disinfection cycle and at the
the right of the IQ and tilt the jug
end.
slowly. The liquid pours slowly
• Stella will detect if the
and steadily into the instrument
instrument has a blockage.
compartment.
• Stella will detect if cleaning
Fill the instrument compartment solution vs water is added.

MANUAL PRE-CLEANING, STELLA

CLEANING & DISINFECTING
in the Base with the full five

OPERATING PROCEDURE
litres of Tristel Fuse for Stella
disinfectant. The liquid will
overflow over into the overflow
compartment.
When the full five litres of Tristel
Fuse for Stella disinfectant is
added, the disinfection cycle will
automatically start.

Follow the Fuse for Stella instructions for use, and refer to the Safety Data Sheet.

The IQ displays the countdown At the start of the disinfection

of the remaining disinfection cycle, Pulse will start pumping
time (contact time). The the disinfectant through the
animated arrow in the LCD channel of the instrument for
graphic confirms that Pulse one minute and then pause
is pumping. When the pump to hold the disinfectant within
stops the animated arrow the channel.
remains stationary. This is indicated by the solid
green LED light. When Pulse
stops, the green LED light
flashes momentarily
indicating standby.

25
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE DESCRIPTION

After the contact time Stella After 40 seconds of Stella

automatically drains the draining, Pulse pumps air
disinfectant from the Base. through the instrument’s
The animated arrow in the LCD channel to remove
graphic confirms that Pulse is residual disinfectant.
operating. The draining This may take up to one
process may take up to one minute. This is indicated by
minute. Tristel Fuse for Stella the solid green LED light.
does not require any rinsing.
When the Stella is empty there
is an audible reminder that the
cycle is complete.

If the instrument becomes detached from the Stella Pulse tube set during the disinfection cycle, a fail notification
graphic and sound, alternating with a message reporting ‘instrument unhooked’ will be displayed at the end of
the disinfection cycle. An incomplete cycle will be reported and the disinfection cycle must be repeated.

Follow medical device manufacturers’ guidance for any rinsing, drying and storage.

The IQ display confirms that Pulse returns to Standby

the cycle is complete. It asks which is indicated by the
to confirm that the disinfected flashing green LED light.
instrument will be removed for
immediate use or to (sterile)
storage. Confirm by pressing
the ‘OK’ button

Upon pressing the ‘OK’ button, If a new cycle is started, Pulse

a validation code is displayed. follows the instruction from
This validation code should be the Stella IQ. The
noted in the traceability book disinfection cycle starts
for future reference. from the beginning.
The IQ asks if a new cycle
should be started and prompts
the user to press the ‘OK’
button. A new cycle can
immediately be started by
pressing the ‘OK’ button again.

Turn off the IQ by pressing the

OFF button. There is a sound to If the IQ is turned off, Pulse
indicate that the IQ and Pulse will switch off automatically
are switching off.

26
SECTION FIVE
MAINTENANCE

27
SECTION 5: MAINTENANCE
BLUETOOTH PAIRING PROCESS
Stella IQ and Pulse are supplied paired from the manufacturer.
However, if either unit is replaced, the following Pairing Process must be completed:

1. Switch on Stella Pulse.

2. Switch on Stella IQ and press the ‘ON/OK’ button two more times and the “Bluetooth Pulse Search”
logo will display followed by “Bluetooth”. The search commences.

3. Once the Bluetooth link is established, any available Pulse units will display by product serial number.

> Pulse 100598

Pulse 100366

Use the ‘ON/OK’ button to scroll the arrow to the Pulse unit serial number you wish to pair the IQ too.

4. Hold down the ‘ON/ OK’ button for 4 seconds or more until the IQ ‘beeps’
and the “Bluetooth Pairing Complete” graphic displays.

5. Stella IQ and Pulse will now return to “read instructions” and are ready to start a disinfection cycle.
If a new disinfection cycle is not required, turn Stella IQ off, which will also shut down Stella Pulse.

BARCODE VALIDATION
If utilizing a scanning software package for audit trail, the Stella with Pulse and Cleaning variant can issue
a validation barcode when a decontamination cycle has successfully completed.
The barcode used is 128 format. This feature operates with a 2D image scanner, a laser scanner cannot be used.
To enable this feature, complete the following steps;

1. Connect the USB cable to the PC and connect to Stella IQ.

2. Wait until the USB symbol displays on the Stella IQ screen.
3. Press the Stella IQ ‘ON’ button three times to enter the screen for turning the barcode validation on or off.
4. The black box with white text specifies which option is set;

Validation code The validation code with barcode

with barcode is set on. If you wish to turn it
off, you need to select the ‘OFF’
OFF key = Barcode off Button on Stella IQ.

Validation code The validation code without

without barcode barcode is set on. If you wish to
turn it off, you need to select the
OFF key = Barcode on ‘OFF’ Button on Stella IQ.

28
5. Remove the USB cable from Stella IQ, and push the ‘ON’ Button once,
then the ‘OFF’ Button to switch the equipment off.
6. Stella is now ready to with the selected validation code option.

Example of validation barcode;

LUBING STELLA IQ
Every 6 months apply Stella Lube (silicone lubricant) to Stella IQ drainage inlets
to ensure a firm fit of the IQ to the base.

1. Wearing gloves apply a small amount of Stella Lube to the outside

perimeter of each of the drainage inlets (spread the lubricant evenly
around the surface of the inlets). DO NOT apply lubricant to the IQ drain
outlet onto which the drain hose is attached.
2. Wash your hands carefully after applying the lubricant.

For video instructions visit the help section on www.stella-performance.com.

Only use Stella Lube on Stella IQ drainage inlets.

ORDERING REPLACEMENT PUMP HOSE SETS

Each new Stella Pulse unit comes with a fitted Pump Hose, and one spare Pump Hose Set.

MAINTENANCE
It is recommended that as soon as a hose is replaced, that a spare part be ordered.

STELLA PUMP HOSE REPLACEMENT PROCESS

You will find a Pump Hose Replacement Instruction card
and screwdriver in your Stella Toolbox.
Equipment you will need for pump hose replacement process:-
• Stella Pulse.
• Pump Hose Replacement Set.
• Flat Head Screw Driver located in the Stella Toolbox.

1. Ensure that Stella Pulse is turned off. Lift the green cover on Stella Pulse.

29
2. Using a flat head screw driver, unscrew the clear window and remove from Stella Pulse.

3. Remove the pump hose by lifting the pump hose connector on one side. Turn the green pump head
clockwise to lift the curved hose, and then lift the pump hose connector on the second side.

4. Insert the new pump hose into Stella Pulse. Place the left hand pump hose connector in first. This is the
smaller connector with the plastic point. The hose then curves around the green pump head which can
be turned by hand. Check that the hose is pushed down at the rear of the green pump head. The right
hand pump hose connector is then locked into place.

5. Replace the window, ensuring that the back ridge is pushed back correctly into Stella Pulse, and then fix
the screw securely, taking care not to over tighten.

For video instructions, go to the help section of the Stella website www.stella-performance.com/help/.
Re-order spare Pump Hose parts from your Stella Sales Agents. Follow the re-cycle program instructions
from your Sales Agent which reduces the cost of spare parts.

The pump hose connectors will not fit if they are not connected to the correct sides of Stella Pulse.
Stella Pulse will not operate if the Window is not replaced correctly.

30
THE BATTERY
BATTERY LEVEL INDICATOR AND CHARGING PROTOCOL
Stella IQ reports the battery status for both Stella IQ and Stella Pulse. The Stella IQ LCD screen will
reference Stella Pulse in the graphic when reporting on that product. There are five levels of charge:

The battery is 76 - 100% full

60 - 80 cycles available

The battery is 51 - 75% full

41 - 59 cycles available

The battery is 26 - 50% full

21 - 40 cycles available

The battery is 11 - 25% full

9 - 39 cycles left

The battery is 0 - 10% full

0 - 8 cycles left

CHARGING
Before switching off, the display will show
that the battery needs charging.

When charging, the battery is full only when

MAINTENANCE
the full battery graphic is displayed.
Pulse Stella Pulse will indicate charging is complete
when the green light is constant.

Stella IQ will not allow the start of a disinfection cycle when there is insufficient battery left to support a full cycle.

To prolong battery life, a full battery charge of 12 – 16 hours should be completed at least once a month
and when the battery display indicates low battery.

Cycles are indicative. As the product ages the cycle numbers will decrease.

Units should be put on full overnight charge once a week, or if frequently used twice a week.

The battery life of Stella IQ and Pulse is dependent upon operating conditions and frequency of use.
If Stella IQ or Pulse ceases to perform due to battery failure, contact your Stella Sales Agent.
The battery may only be replaced by an authorised trained technician.

31
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE

To charge the battery, disconnect Stella IQ

or Pulse from the Base. Stella IQ and Pulse
will not operate whilst being charged.

Do not charge Stella IQ or Pulse whilst they are attached to the Base or near any forms of liquid.

Only the supplied power adaptor should be used for charging the Stella IQ and Pulse units.
Use of other adaptors may damage the equipment or cause malfunction.

CHARGING THE BATTERY OF THE IQ AND PULSE

Stella Power Adaptor

Follow illustration to fit mains power plug pins
into place, ensure the plug has clicked into place.

To replace the mains power plug pins, press the

release button below and slide the plug up to remove.

Open the protective cover of the power port

on the back of Stella IQ or Pulse.
Plug in the power adaptor supplied and connect
to the mains power supply.
The IQ display shows the status of charging the unit.
For Pulse indicators, please see the table below.
The symbol for a fully charged battery indicates that
the charging process is complete. A full charge takes
12 – 16 hours.
When using the IQ and Pulse for the first time,
always charge the battery to ‘full’.

PULSE BATTERY INDICATORS

PULSE REFERENCE DESCRIPTION
Green light Battery Charged.
constant.

Battery Low. Top Light

Green light
Charge Battery. Power status
flashing on and off.

Yellow/Orange light Charging - when adaptor is

flashing on and off. plugged in this indicates
charging is in progress.
32
DOWNLOADING THE INFORMATION
A record of every part of the disinfection process is stored in the memory of Stella IQ (for both Stella IQ and
Pulse). This data should be downloaded regularly and stored in a safe place together with the Stella Audit
Record Book, if used, for future reference.
Prior to downloading information from Stella IQ, Stella Suite software must be installed on the computer
to which Stella IQ will be downloaded. Please refer to the Stella Suite instructions for use, which can be
downloaded from the Stella Suite.
There are two options to download the data from Stella IQ:
1. via USB
2. via Bluetooth
These options are explained within the following pages.
To download the data, disconnect Stella IQ from the Base and place it on a stable surface away from liquids.

Stella IQ cannot perform any disinfection cycles whilst downloading.

Ensure the Stella Suite software has been installed on the computer prior to plugging the USB cable
into the Stella IQ.

DOWNLOADING VIA USB CABLE

STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE

MAINTENANCE
On your PC, open the Stella Suite and follow the
instructions on screen.
Connect the USB cable to your computer.
Open the protective cover of the USB port on
the back of Stella IQ and connect the USB cable
to the IQ.
The IQ automatically detects the USB connec-
tion to the PC. The IQ display will light up to
show the Stella logo.
Do not push the ‘ON’ button. If you do so, turn
off Stella IQ, and repeat the steps above.
The IQ is now ready for download via USB
connection. The USB Download symbol is
displayed on the screen.
Choose the download icon option on the Stella
Suite toolbar. Stella IQ displays the transfer
of data. Once the download is complete,
disconnect the USB cable. The Stella IQ will
automatically switch off.

Remove the USB cable and reseal the cover over the USB port on the IQ.
Ensure the cover is securely sealed to prevent the ingress of water or disinfectant into Stella IQ.

33
DOWNLOADING VIA BLUETOOTH
STELLA IQ: STELLA PULSE:
ILLUSTRATION DESCRIPTION IQ REFERENCE

Turn on the Bluetooth connection on your

computer and place Stella IQ within a ten
metre range of the computer.
Press the ‘ON’ button on the IQ until you hear
a sound.
While the Stella logo is displayed on screen,
press the ‘ON’ button again until the operation
mode screen appears. Use the ‘ON’ button to
select the download option.
Stella IQ is now ready for download via Bluetooth
and displays the Bluetooth symbol on its screen.
On your computer, open the Stella Suite. Follow
the instructions on screen and link your
computer to Stella IQ via Bluetooth.
(Also refer to the Stella Suite user instructions).
Once the link is established, Stella IQ displays
an active signal.
Choose the download icon on the Stella Suite
toolbar. Stella IQ displays the transfer of data.
Once the download is completed, shut down
Stella IQ by pressing the ‘OFF’ button.
If Stella IQ is not switched off, it will shut
down automatically after 30 minutes.

34
CLEANING, DISINFECTION AND STERILISATION OF STELLA,
IQ AND PULSE
STELLA BASE AND LID CLEANING PROCEDURE
Local guidelines and Hospital protocols should be referred to for equipment cleaning requirements.
Tristel recommend visual debris should be cleaned from Stella Base, Lid and Small Parts tray after use.
Every disinfection cycle completed in Stella provides disinfection to the inner compartment of the base
and the inner compartment footprint of the lid.

DO NOT AUTOCLAVE the Stella IQ, Pulse, Cradle, power adaptors, grommets or any other accessories.

DO NOT IMMERSE Stella IQ, Pulse, power adaptors or USB cable in water or any other liquid.

Stella IQ and Pulse Power covers must be firmly sealed to protect units from ingress of fluid.

STORAGE AND OPERATING CONDITIONS

Stella IQ and Pulse are suitable for operating and charging in temperatures of 10 to 35°C
with a maximum allowable humidity of 90% (within the prescribed temperature range).

MAINTENANCE
Stella Base with Lid measure 70cm x 48cm x 18cm and weigh 5.5kg when empty.
The Base and Lid can be stacked and easily transported due to their portable size and weight.

Stella Cradle measures 84cm x 48cm. The height is variable depending on the adjustment of Cradle
feet, but on average when holding Stella Base measures 23cm. Refer to page 5 for full Stella footprint
measurements.

The drainage outlet cap can be used when transporting Stella Base to contain any small droplets of
disinfectant that may be left in the Base. Do not use the drainage cap to hold solution in the Base.

35
DISPOSAL CONSIDERATIONS
The Stella Base, Lid, and Small Parts Tray can be recycled once decontaminated.
Autoclaving is recommended prior to disposal.

The IQ and Pulse units contain batteries and electronic components and must be disposed of in
accordance with local regulations, or returned to the local Stella Service Agent for disposal. The units
should be decontaminated using chemical high-level disinfection prior to disposal. For further information
refer to your local Stella Service Agent.

OTHER
In the event of damage to parts within the Stella System, contact the manufacturer or your local Stella
Service Agent to purchase replacement parts.

If you experience a problem with the operation of the Stella System, please refer to the Troubleshooting
section of this manual.

Should you not be able to resolve the operational problem, contact your local Stella Service Agent. Before
calling, please ensure that you have serial numbers of the hardware and revision numbers of the software:

• Hardware serial numbers can be found on the unit product labels.

• Software revision numbers can be found by downloading the data log report using the Stella Suite.

Stella IQ, Pulse and their power adaptors should periodically be tested for electrical safety in accordance
with local health and safety procedures.

36
SECTION SIX
TROUBLESHOOTING GUIDE & GLOSSARY

37
SECTION 6: TROUBLESHOOTING GUIDE & GLOSSARY
TROUBLESHOOTING GUIDE AND FREQUENTLY ASKED QUESTIONS
In this section you will find a troubleshooting guide to assist if you have problems with operating the
Stella System.
This troubleshooting guide is your first port of call in resolving issues.
This section covers the following troubleshooting topics:
• Damaged Goods
• Battery Reporting
• Stella Pulse LED Light Reporting
• Stella IQ LCD Display and Troubleshooting
• Frequently Asked Questions
If you are unable to resolve an issue after referring to this guide, please contact your local Stella Service
Agent. A list of contacts can be found in the Contacts section of this manual.
If for any reason the Stella Equipment needs to be returned, you must first contact the Stella Service Agent
you purchased your Stella equipment through to register the return and initiate an investigation process.
You will be required to complete a product return form which is contained in the last page of this section.

DAMAGED GOODS
If goods are damaged during delivery, it is the user’s responsibility to contact the Sales Service Agent
immediately.
If the equipment is dropped during use, the user should run a cycle through Stella to check it is operating
correctly and contact the Stella Service Agent if any damage has occurred.

38
BATTERY MANAGEMENT
BATTERY LEVEL INDICATOR AND CHARGING PROTOCOL
Stella IQ reports the battery status for both Stella IQ and Stella Pulse. The Stella IQ LCD screen will
reference Stella Pulse in the graphic when reporting on that product. There are five levels of charge:

The battery is 76 - 100% full

60 - 80 cycles available

The battery is 51 - 75% full

41 - 59 cycles available

The battery is 26 - 50% full

21 - 40 cycles left

The battery is 11 - 25% full

9 - 20 cycles left

The battery is 0 - 10% full

0 - 8 cycles left

CHARGING

Before switching off, the display will

Charge warning.
show that the battery needs charging.

Charging of IQ battery has

commenced. Stella Pulse indicates
Charging commenced.
charging is in progress when the
adaptor is plugged in and the Yellow/
Orange LED light is flashing.

TROUBLESHOOTING
GUIDE & GLOSSARY

When charging, the battery is full only

when the full battery graphic is
Charging complete. displayed. Stella Pulse will indicate
charging is complete when the green
light is constant.

The battery or charging system may

have developed a fault or have
become excessively discharged during
long periods of storage. Place the
Battery not detected. unit on charge for 12 - 16 hours, then
disconnect and reconnect the charger.
If the problem persists, contact your
Stella Service Agent.

39
 The battery or charging system may
Battery needs replacing have developed a fault. Contact your
Stella Service Agent.

Stella IQ will not allow the start of a disinfection cycle when there is insufficient battery left to support a full cycle.

To prolong battery life, a full battery charge of 12 – 16 hours should be completed at least once a month
and when the battery display indicates low battery.

Cycles are indicative. As the product ages the cycle numbers will decrease.

Units should be put on full overnight charge once a week, or if frequently used twice a week.

PULSE LED LIGHTS

Stella Pulse has a series of three LED lights that reports battery, connection and pump activity.

Power Button

Power Status LED

Bluetooth Status LED
Pump / Fault Status LED

POWER STATUS LED

Green light constant. Battery Charged.
Green light flashing on and off. Battery Low.
Yellow/Orange light flashing on and off. Charge battery.
Charging - when adaptor is plugged in this indicates
charging is in progress.

BLUETOOTH STATUS LED

Blue light flashing on and off. Bluetooth Search Mode.
Blue light constant. Bluetooth link established.
No light. Off – no Bluetooth link.

PUMP STATUS LED

Green light constant. Pump operating.
Green light flashing on and off. Pump ready – in standby mode.
Red light flashing. Pump failure.
Red light constant. System failure.

40
STELLA IQ LCD GRAPHICS
In this section you will find a table of failure codes, their descriptions and actions for troubleshooting.

LCD GRAPHIC WHAT HAS HAPPENDED? TROUBLESHOOTING

5 Litres of Tristel Fuse for Stella Manually activate the start of the
have been added to Stella but the disinfection cycle by pressing the ‘ON’
Disinfection cycle does not start. button. If problem persists there may
Moisture may be present in the be a moisture droplet trapped in the
sensor tube prior to starting a cycle. sensor tube. Holding the IQ horizontal,
This should clear after the cycle has press the ‘ON’ button. This will close
completed. the valve. Then flush clean water into
the drain inlet, turn over and flush the
outlet. Leave the Stella IQ to dry. Once
dry, restart Stella IQ.

The graphic will notify whether it is IQ

In the event of a user error, or a
or Pulse related, and the number in the
problem that may be resolvable on
corner alerts us to the table below for
site, a graphic will display.
how to address.

There is no disinfectant in the Base.

Stella IQ has detected an Remove Stella IQ from the Base and
obstruction and the ball valve will inspect the IQ drainage outlets for
not close. blockages with foreign objects and
remove any debris. Refer to the Ball
Valve Cleaning Procedure in the Service
Manual.
Restart the cycle. If the problem
persists a blockage may have occurred

TROUBLESHOOTING
GUIDE & GLOSSARY
higher in the Ball Valve area and the
unit will need to be returned to the
Service Centre to clear.

The disinfection cycle has not

successfully completed and must be
repeated. Turn off Stella IQ and Pulse.
Start the Bluetooth communication
Stella Pulse Bluetooth link has been process again by first switching on
lost. Stella IQ then Pulse.

If this frequently occurs, the Pulse

battery may have aged. Contact your
Service Centre.

41
LCD GRAPHIC WHAT HAS HAPPENDED? TROUBLESHOOTING

Stella Pulse Software is not Open Stella Suite and connect the IQ via
compatible with Stella IQ Software USB cable to the computer. Go to help
menu and “check for software updates”.
When completed repeat the process
with Stella Pulse. If Stella Suite is not
installed, visit:-
www.stella-performance.com/
usingstella/updatestella and install
Stella Suite Software

Stella Pulse has detected a The disinfection cycle has not

blockage which could be related completed successfully. Disinfectant
to the Pump Hose, Tube Set, Pulse in the Base will be drained to waste.
Window not replaced correctly, or a Check the instrument for blockages,
blocked instrument, or instrument check the instrument tap is not closed,
tap closed. and visually inspect the Tube Set
connected to the instrument for
blockage. Open Pulse Window by
110/111/112/114
following the Pump Hose Replacement
instructions above. Remove the Pump
Hose and check that it is not pinched.
If pinched, massage the tube between
fingers to return to round shape.
Replace the Pump Hose, replace
Pulse Window, and restart the cycle.

Stella IQ is not detecting solution. If this occurs prior to the start of the 5
The Pulse strainer is either not minute disinfection cycle the user will
submerged in the disinfectant or the be asked to ‘confirm instrument
left hand Tube Set connection is not connected’.
connected to Pulse unit.
First ensure that the strainer is fully
submerged in the Base inner
compartment, that the Tube Set is
connected to the instrument and that
the Tube Set Connectors are connected
to Pulse unit.
Stella IQ gives three chances / or
a total of 1 minute to make the
connection requesting ‘confirm
instrument connection’ by pushing
the ‘ON’ button. If the connection is
not made, or this occurs during the
disinfection cycle error code 113 will be
displayed. The disinfection cycle has
not successfully completed and must
be repeated.

42
LCD GRAPHIC WHAT HAS HAPPENDED? TROUBLESHOOTING

Stella has identified that the If this occurs prior to the start of the
instrument has not been connected disinfection cycle, reconnect Pulse Luer
to Pulse or that it has become Lock Connector to the instrument
disconnected during the within a 30 second time frame and ‘Confirm
disinfection cycle. Instrument Connected’ by pressing the ON
button.
Ensure that gloves and appropriate
115/125
personal protective equipment are worn
when Pulse tubing is being
reconnected. If the connection takes
longer than 30 seconds, cannot be made,
or occurs during the disinfection cycle,
disinfectant will drain to waste. In this case
the disinfection cycle has not successfully
completed and must be repeated.

Tristel Fuse for Stella disinfectant is The disinfection cycle has not
not detected successfully completed and must be
repeated.
Stella has not detected Tristel Fuse for
Stella. The cycle has failed: water will be
automatically drained from Stella.

In the event of equipment errors that The X graphic will notify whether it IQ or
cannot be resolved on site a “X” Pulse related, and the number in the corner
graphic will display. alerts to the problem.
If the issue relates to both IQ and Pulse a
Generic X Stella will display.
Please make a note of the graphic details
and contact your Stella Service Agent.

TROUBLESHOOTING
GUIDE & GLOSSARY

43
FREQUENTLY ASKED QUESTIONS
POWER
For further information refer to the Electromagnetic Emission tables in the regulatory and warranty section of this manual.

Stella IQ or Pulse will not power up or is operating intermittently.

• Stella IQ will not start a cycle if there is not enough charge in the batteries to finish a full cycle.
• Place Stella IQ and Pulse on charge for 12 - 16 hours.
• For urgent use only: the IQ or Pulse must charge for a minimum of three hours before it can be operated.

Stella IQ or Pulse fails to start or stays switched off.

• Place Stella IQ and Pulse on charge for 12-16 hours.

While charging, Stella IQ or Pulse fails to power up or charges intermittently.

• Check that the green indicator light on the adaptor is lit. If it is not lit, contact your Stella Service Agent.

Stella IQ or Pulse fails to switch on or off.

• Contact your Stella Service Agent.

As Stella IQ and Pulse batteries age, their capacity to store energy decreases.
If equipment charge levels drop quickly or after full charges, few cycles are completed, contact your
Stella Sales Agent.

HARDWARE
Water is leaking from the base of Stella.
• Check the Stella IQ is attached firmly to the Stella Base. Ensure that the drain hose is attached and is watertight.
• Applying the Stella Lube (for instructions, see the Introduction section of this manual) will assist a firm fit to the
Base. Visit www.stella-performance.com help section for video guides.

Water is leaking from the Valve outlet.

• Note: Excess liquid will exit the outlet when Stella is filled. Even when filling the instrument compartment with
five litres, a small amount of liquid will flow into the overflow compartment and out through the drain hose at
the start of a cycle.
• If there is a continuous leak throughout the cycle, the Valve may not have closed correctly.
• Flush the System with clean water. Remove any foreign matter from Stella IQ’s drain outlets.
Water leaks appearing from the electronics enclosure power cap.
• Discontinue use immediately and contact your Stella Service Agent.

LCD display is hard to read.

• Remove Stella IQ or Pulse from direct heat source or direct sunlight. If the problem persists,
contact your Stella Sales Agent.

The LCD display is intermittent.

• Contact your Stella Sales Agent.

44
COMMUNICATION
For further information refer to the Electromagnetic Emission tables in the regulatory
and warranty section of this manual.
USB: Download or Firmware Upgrade is erratic or not possible.
• Check the USB cable is in a good condition with no cable damage, broken or visible wires.
• Check plug connections are in good working order.
• Check the Stella Suite installed on your computer is the latest version. The latest available version of
Stella Suite software can be found at: www.stella-performance.com (go to Using Stella / Update Stella).
• Refer to the Stella Suite Installation Guide for the correct installation process for your operating system.
• The USB driver may have been installed in the incorrect location.
• Go to the Start menu on your computer and select:
Settings/ Control Panel/ System/ Hardware/ Device Manager
• Plug the USB cable into Stella IQ and then your computer and observe where “USB Tristel” appears in your list.
If it appears in the main list and not under Universal Serial Bus controllers, it needs to be shifted.
• To shift select your device manager list and select ‘Update Driver’. Follow the wizard. In the wizard select
‘Search for the best drivers in these locations’ then browse to the following path:
C:\Program Files\Stella\Stella_Suite
• The driver should now install in the correct location. When complete, unplug the USB from Stella IQ.
Bluetooth: Download erratic or not possible.
• Follow the “Stella Suite Bluetooth Installation User Guide” which can be found in the Help section of the
Stella Suite.
• Note: Stella Suite must be installed onto the computer, and the Bluetooth link configured according to the
Bluetooth device instructions used on the computer.
• Switch on Stella IQ into Bluetooth mode by pressing the ‘ON’ button then pressing again during the
display of the Stella logo.
• Click the Bluetooth icon at the bottom of your computer screen to identify the com port assigned for IQ.
• Open Stella Suite, in the file tab choose ‘Configure’, select the Bluetooth window, and then tick ‘Use Blue-
tooth’.
• Select the COM PORT assigned to Stella IQ and click OK. Close the Stella Suite (the serial port pairing code for
the com link is “1234”).
• Neighbouring electrical equipment and mobile radios may cause electrical interference and affect the
performance of the Bluetooth communication link.

TROUBLESHOOTING
• Move Stella IQ and the computer away from strong electromagnetic devices such as radio transmitters and GUIDE & GLOSSARY
electromagnetic MRI imaging equipment etc.
• Move Stella IQ within a 10 metre radius of the computer.
Stella IQ or Pulse will not power up after a firmware update.
• Plug in the power adapter or USB cable and press the ‘ON’ button once to check firmware version.
• Check that the correct and latest firmware is installed. Repeat update if necessary.
• During any firmware update, do not remove the USB cable until the update is 100% completed
(denoted by two beeps).
• Check USB cable or power adaptor is in good working condition.

45
Failure alarm occurs after firmware update.
• The Firmware may not have installed correctly.
• Go to Stella Suite Help menu, select “Check for Stella IQ updates” and “Check for Stella Pulse updates”.

No Stella log events are displayed after the immediate second download.
• By default the Stella Suite will only download events that took place since the last download. Therefore an
immediate second download will not display any detail in the report until further events have taken place using
the Stella System.
• To view previous events, click on the EVENT FILTER Icon, choose the date range you would like to view events
from then click OK. The events report will now be displayed.

Stella IQ does not automatically activate the disinfection cycle or constantly requires manual activation.
• Check that the Stella System is located on a level and stable surface. If not, Stella Cradle can be used to level
your Base.
• If this does not resolve the issue then a blockage may have occurred inside the drain inlet. Restart Stella
IQ. Water or air bubbles may be affecting the internal sensor. In this instance the unit will require manual
activation. Hold down the ‘ON’ button to manually activate.

If any issues persist, contact your Stella Service Agent.

The contact details can be found in the ‘Contacts’ section of this manual.

GLOSSARY OF THE GRAPHICAL SYMBOLS USED ON THE STELLA SYSTEM

OBSERVE ALL SYMBOLS – SYMBOLS ARE FOR YOUR SAFETY AND ENVIRONMENTAL PROTECTION
Read instruction before use
This manual contains information for the safe use and handling of the Stella
system and power supply. In explains the installation and the mains adaptor
power supply for charging the Stella units.
Prevent shock-hazard
• Always read the instruction manual first before using the power supply
• Risk of electric shock - Use approved Power Adaptor only
• While charging place Stella units and power adaptor in a dry area
• Do not use power adaptor in wet areas
• Never use a power adaptor with damaged housing or cable
• Never modify the power adaptor or opens its housing
• Connect the power adaptor to a regular power outlet
• Protect connectors from moisture and damp areas
Prevent property damage
• Never carry the power adaptor by its electrical cable or pull at the cable
• To remove the adaptor from the power outlet always pull on the plug, never the cable.
• The DC power cable must be installed safely to avoid tripping over
• Disconnect the power supply during thunderstorms
• Only use original spare parts or accessories supplied with the power adaptor
• Keep power covers closed when Stella units are in use
Personnel protection
• Wear protective clothing and protective eye wear during use
• Do not place Stella units on charge in wet areas
• Keep working area and walkways clear of obstacles
• Ensure appropriate safety precautions are observed during use
• Ensure adequate lighting is provided for the Stella system working area
• Identify areas for potential leakage and rectify before use
• In the event of spillage clean and dry the area immediately

46
 Operating Temperature
Operation within 10°C to 35°C with a maximum allowable humidity of 90%
(within the prescribed temperature range).
Store and transport within the temperature range of -10°C to +40°C.
For indoor use only
Use Stella system in designated area for disinfection of medical devices.

CE Mark
The Stella Devices conform to the European Regulation (EU) 2017/745.

FCC Mark
The Stella system complies to the Federal Communications Commission
Regulation FCC 47 CFR Part 15, Subpart B (Unintentional Radiators).

Ingress Protection
Protected against dust ingress and water spray from all directions
with Power covers closed. Limited ingress may occur.

Bluetooth enabled

USB enabled

Disposal
Recycle in accordance with the WEEE Directive.
Under the European Directive 2012/19/EU this electronic device must not be
disposed of to normal waste. Dispose of the Stella system, power adaptor and
batteries via the designated take-back system. Contact your local supplier.

Restriction of Hazardous Substances - RoHS 3

Under the European Directive 2015/863 this electronic device complies
with the maximum levels for restricted substances.

Material can be recycled

Serial Number

Lot Number

Date of manufacture

Fragile. Handle with care.

Do not stack pallets.

47
SECTION SEVEN
REGULATORY & WARRANTY INFORMATION

48
SECTION 7: REGULATORY & WARRANTY INFORMATION
WARRANTY FOR STELLA IQ AND STELLA PULSE
LIMITED WARRANTY
Tristel Solutions Limited (hereafter referred to as “the Company”) warrants that the Stella System,
Pulse and associated parts and accessories (hereafter referred to as “the Product”) will conform to the
Company’s written specifications and will be free from defects in material and workmanship under its
designated, normal use and service.
Notwithstanding anything herein to the contrary, the warranty period for the Stella System, comprising
of Stella IQ, Stella Pulse, Stella Base, Lid and accessories supplied by the Company is twelve (12) months
shown from the date of invoice.
Both the Stella IQ and Stella Pulse, if handled appropriately and in accordance with user instructions,
have a Warranty Period of twelve (12) months from date of invoice. Stella IQ and Pulse should be
registered on the Stella Performance website www.stella-performance.com/register.html for the
warranty to be valid and before any warranty claims can be handled.
Warranties shall be made invalid by the misuse of, or unauthorised tampering with, the Product.
The warranty does not cover, and the Company will have no warranty obligation whatsoever with respect
to any damage to the Product caused by or associated with: (1) external causes, including without
limitation, accident, vandalism, power failure or electrical power surges, (2) abuse, misuse or neglect of
the Product by the customer or any other user or through use of unauthorised third party consumables and
accessories, (3) usage not in accordance with the product Instructions For Use, (4) the customer’s failure to
perform required preventive maintenance and care, or (5) servicing or repair not authorised by the Company.

LIMITATION OF REMEDY
The warranty obligation of the Company hereunder is limited to the repair or replacement (at its option) of
the defective Product or any parts it deems defective. This will be the customer’s exclusive remedy for a
covered defect.
In order to recover under the warranty, the customer must notify the Company or its representative in the
country of installation of the defect prior to expiration of the warranty period and within thirty (30) days
of discovery of the defect. The notification to the Company must include a description of the problem in
reasonable detail and the full report downloadable from the IQ using the Stella Suite, showing all details
starting seven (7) days before the defect was first noted. Upon receiving the Company’s official “return
goods authorisation” (RGA), the customer must promptly return the defective part or Product to the
Company (or the authorised representative) as indicated on the RGA, freight and insurance prepaid.
The Company will not be responsible for any damage during shipment.

WARRANTY DISCLAIMER
The Warranty above is the Company’s entire warranty obligation to the purchaser of products. It is in
lieu of all other warranties of the Company, express or implied, including, without limitation, warranty
of merchantability or fitness for a particular purpose, and the company does not represent or warrant
that any product will meet customer’s requirements. The Company’s responsibility for defects in a
product is limited solely to repair and replacement as set forth in this warranty statement.
To the extent permitted by law, the Company shall not, under any circumstances, be liable to the
customer for consequential, incidental, indirect or special damages or losses, including without
limitation, damages arising out of or in connection with any malfunctions, delays, loss of profit,
interruption of service, or loss of business or anticipatory profits, even if the Company has been
apprised of the likelihood of such damages occurring.
This Warranty gives the customer specific legal rights, and customers may also have other rights
which vary from jurisdiction to jurisdiction.

49
In no event shall the Company’s liability exceed the original purchase price of the covered Product. No
representative or agent of the Company has the authority to bind the Company to any other representation or
warranty with respect to the Products, and the customer accepts the Products subject to all of the terms above.

TECHNICAL SPECIFICATIONS
Power adaptor FRIWO Model No. FW 7660M/12 GPP10-M (1950082)
AC mains 100~240Vac, 50/60Hz, 205~110mA, Interchangeable mains plugs
DC Output 12V ±2%, 800mA, 2.5mm DC Jack, (+) centre
Isolation Protection Class II - AC mains and DC output are electrical safety isolated
Working Temperature 0°C … +40°C
Storage Temperature -20°C … +70°C
Humidity 5% to 95%
Ingress Protection IP40
Atmosphere pressure 70-106kPa
Maximum altitude 2.6km above sea level
Weight 160gm
Low Voltage Directive IEC/EN 60601-1 ED, IEC60601-1, ES60601-1
Safety Standard AS/NZS 3112, VDE EN50075, EN60950-1, UL1310
EMC Directive EN 60601-1-2, IEC EN 61326-1
Cable length 1.8m

Stella IQ
Input Voltage 12Vdc, 300 mA
Ingress Protection IP64 With Power cover closed. Dust tight, protected from water splash
Pollution Degree Assessed to pollution degree 3. Conductive pollution is to be expected
Humidity 10% to 90%
Weight 840gm
Working Temperature 10°C ~ 35°C
Transport Temperature -20°C to +50°C
Storage Temperature -10°C to +40°C
Charge Temperature 10°C ~ 35°C
Low Voltage Directive IEC/EN 61010-1, 61010-2-040 Part 2 – Washer Disinfectors
EMC Directive IEC EN 61326-1
Battery Pack Part No. 210AAHCB4BMLQM, 4.8V NiMH, 2000mAh, 117gm
REGULATORY & WARRANTY

Battery standard charge 200mA (0.1C) 16hrs, 6Vmax

INFORMATION

Battery Service Life IEC Cycles test ~ 1000, (IEC 61951-2)

Stella Pulse
Input Voltage 12Vdc, 650 mA
Ingress Protection IP64 With Power cover closed. Dust tight, protected from water splash
Pollution Degree Assessed to pollution degree 3. Conductive pollution is to be expected
Humidity 5% to 90%
50
 Weight 1560gm
Working temperature 10°C ~ 35°C
Storage temperature -10°C to +40°C
Transport temperature -20°C to +50°C
Charge temperature 10°C ~ 35°C
Low Voltage Directive IEC/EN 61010-1, 61010-2-040 Part 2 – Washer Disinfectors
EMC Directive IEC EN 61326-1
Battery Pack Part No. 450LAH10YQM, 12V NiMH, 4500mAh, 622gm.
Battery standard charge 450mA (0.1C) 16hrs, 15Vmax
Battery Service Life IEC Cycles test >500, (IEC 61951-2)
Stella Base with Lid 70cm x 48cm x 18cm
Base capacity 5Litres
Weigh 5.5kg when empty
Stella Cradle 84cm x 48cm

REGULATORY INFORMATION 
The Stella System is CE marked as a Class IIb medical device as per the Medical Device Regulation (EU) 2017/745,
for washer – disinfectors intended for disinfecting invasive devices and Low Voltage Directive (LVD) 2014/35/EU.
Stella is designed and manufactured to conform to the following standards:

Council Directive (EU) 2017/745 of 5 April 2017 concerning medical devices

Directive (LVD) 2014/35/EU Low Voltage Directive (LVD) 2014/35/EU enforced 23 April 2016

Directive (EMC) 2014/30/EU Electromagnetic Compatibility (EMC) 2014/30/EU enforced 20 April 2016

Medical Devices - Qualitative management systems.

BS EN ISO 13485:2016
Requirements for regulatory purposes
Medical electrical equipment. General requirements for basic safety
BS EN 60601-1:2006 +A12:2014
and essential performance – (Relating to Power Adaptor)
AS 61010.1:2003(R2016)
Medical Electrical Equipment. Part 1: Safety requirements for electrical equipment
BS EN 61010-1:2010+A1:2019
for measurement, control, and laboratory use. General requirements
IEC 61010-1 3.1: 2017
BS EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control and Laboratory use
Part 2-040 – Particular requirements for sterilisers and washer disinfectors used to treat medical devices
BS EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use.
IEC 61326-1:2012 EMC requirements. General requirements
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN 62304:2006+A1:2015 Medical device software. Software life-cycle processes
BS EN 61000-3-2:2014
Electromagnetic compatibility (EMC) - limits for harmonic current emissions
IEC 61000-3-2:2014 Ed4.0
BS EN 61000-3-3:2013 Electromagnetic compatibility (EMC) - limitation of voltage changes,
IEC 61000-3-3:2013 Ed 3.0 voltage fluctuations and flicker in public low voltage supply systems
AS/NZS CISPR 11:2011
Industrial, scientific and medical equipment. Radio-frequency disturbance characteristics.
BS EN 55011:2009
Limits and methods of measurement.
CISPR11: 2009 + A1: 2010
AS/NZS 61000-4-2:2013
Electromagnetic compatibility (EMC) - testing and measurement techniques
BS EN 61000-4-2:2009
– electrostatic discharge immunity test
IEC 61000-4-2:2008
AS/NZS 61000-4-3:2013
BS EN 61000-4-3:2006 +A1: 2010 Electromagnetic compatibility (EMC) - testing and measurement techniques
IEC 61000-4-3:2006 – radiated, radiofrequency, electromagnetic field immunity test
+A1:2007+A2:2010
51
 AS/NZS 61000-4-4: 2013
Electromagnetic compatibility (EMC) - testing and measurement techniques
BS EN 61000-4-4:2012
– electrical fast transient / burst immunity test
IEC 61000-4-4:2012
AS/NZS 61000-4-5:2006
BS EN 61000-4-5:2006 Electromagnetic compatibility (EMC) - testing and measurement techniques – surge immunity test
IEC 61000-4-5:2005
AS/NZS 61000-4-6:2013
Electromagnetic compatibility (EMC) - testing and measurement techniques
BS EN 61000-4-6:2014
– Immunity to conducted disturbances, induced by radiofrequency fields
IEC 61000-4-6:2013
AS/NZS 61000-4-8:2012
Electromagnetic compatibility (EMC) - testing and measurement techniques
BS EN 61000-4-8:2010
- power frequency magnetic field immunity test
IEC 61000-4-8:2009
AS/NZS 61000-4-11:2005
Electromagnetic compatibility (EMC) - testing and measurement techniques
BS EN 61000-4-11:2004
- Voltage dips, short interruptions and voltage variations immunity tests
IEC 61000-4-11:2004
FCC 47 CFR Part 15, Subpart B Federal Communications Commission Regulations (Unintentional Radiators)
BS 5452 Specification for Hospital Hollow ware - clauses 9,10 and 11 (Relating to the lid and base)
EN 1041:2008+A1:2013 Information supplied by the manufacturer with Medical Devices
2012/19/EU Waste Electrical and Electronic Equipment (WEEE Directive)
2013/56/EU Battery Directive
2015/863/EU Restrictions of Hazardous Substances RoHS 3 Directive

Electromagnetic Emissions and Immunity EN61326-1:2013

STELLA
For electromagnetic emissions the Stella System has been tested for compliance to IEC 61326-1,
CISPR11 Group 1, Class B. Testing has been performed using the following parts with Stella System.

ITEM DESCRIPTION LENGTH MANUFACTURER PART NUMBER

USB Cable Type A to B 1m Dynamix C-U2AB-1
GPP10 Medial Power Plug Pack 1.8m DC lead FRIWO 1950067

WARNINGS
Use of accessories and cables other than those specified, with the exception of the power pack and cables
sold by the manufacturer of the Stella System as replacement, may result in increased emissions or decreased
immunity of the Stella System.

ADJACENT EQUIPMENT
The Stella System should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked
use is necessary, the Stella System should be observed to verify normal operation in the configuration in which
it will be used.

OPERATION IN WET AREAS

Keep the Stella IQ and Pulse units clear from wet areas when they are placed on charge or connected to a
computer terminal using a USB cable. Do not attempt to use the Stella System for disinfection purposes
while charging or downloading. In the case of long-term storage, remove Stella IQ and Pulse from Stella Base
and keep it clear from wet areas.

CLOSE POWER CAP

Remove all cables from the Stella IQ and Pulse units and ensure the rear power caps are closed firmly while
the Stella IQ or Stella Pulse are in use during disinfection cycles and cleaning.
52
Declaration for compliance: The Stella System complies with all IEC 61326-1 Test Levels of this collateral standard
for power frequency magnetic field immunity requirement.

EN61326-1:2013 TABLE 1 – BASIC IMMUNITY

Declaration for compliance: The Stella System complies with all IEC 61326-1 Test Levels of this collateral standard
for power frequency magnetic field immunity requirement.

MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

Immunity test requirements for equipment intended to be used in a basic electromagnetic environment.

Performance
Port Phenomenon Basic Standard Test value
criterion

Electrostatic 4 kV contact discharge

IEC 61000-4-2 B
Discharge (ESD) 8 kV air discharge
B
3 V/m (80 MHz to 1 GHz)
Electromagnetic A
Enclosure IEC 61000-4-3 3 V/m (1,4 GHz to 2 GHz)
Field A
1 V/m (2,0 GHz to 2,7
GHz)
A
Power frequency
magnetic field IEC 61000-4-8 3 A/m (50 Hz, 60 Hz) A

Voltage dip IEC 61000-4-11 0% during half cycle B

0% during 1 cycle
B
70% during 25/30 cycles
C
Short interruptions IEC 61000-4-11
AC Power
0% during 250/300
C
cycles
(Including
protective earth) B
Burst IEC 61000-4-4 1 kV (5/50 ns, 5 kHz)

Surge IEC 61000-4-5 0.5 kV)/1 kV) B

Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A

Burst IEC 61000-4-4 1 kV (5/50 ns, 5 kHz) B

DC power
(including
Surge IEC 61000-4-5 0.5 kV)/1 kV) B
protective
earth)
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
REGULATORY & WARRANTY

I/O signal/ Burst IEC 61000-4-4 0.5 kV (5/50 ns, 5 kHz) B

INFORMATION

control
(including Surge IEC 61000-4-5 1 kV B
functional earth)
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
Mains power quality should be that of a typical domestic or hospital environment.
If disturbance occurs, it may be necessary to position the Stella System further from sources of power
frequency magnetic fields or install magnetic shielding.

53
EN61326-1:2013 TABLE 2 – EMISSIONS
Declaration for compliance: Stella System complies with CISPR11, group 1, Class B,
IEC 61000-3-2 and IEC 61000-3-3.

MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The Stella System is intended for use in the electromagnetic environment specified below.
The end-user of the Stella System should ensure that it is used in such an environment.

Emissions test Compliance standard Test Level

RF emissions energy level CISPR 11 Group 1 - RF energy only for its internal function

RF emissions environment category CISPR 11 Class B - All establishments including domestic

AC power - Conducted emissions CISPR 11 150 kHz - 30 MHz

Enclosure - Radiated emissions CISPR 11 Group 1 equipment - 30 MHz to 1 GHz (OATS)

AC power - Harmonic emissions IEC 61000-3-2 Measurement up to 40th harmonic

AC power - Flicker IEC 61000-3-3 Traceable results only - Complies

Electromagnetic environment – guidance

Group 1 - The Stella System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic equipment.

Class B - The Stella System is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

54
EN60601-1-2:2007 (5.2.2.1) TABLE 3
Declaration of compliance: Stella System which is non-life supporting device that meets IEC 60601 Test Levels of
this collateral standard for the radiated and conducted immunity tests.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The Stella System is intended for use in the electromagnetic environment specified below.
The end-user of the Stella System should ensure that it is used in such an environment.

IEC 60601
Immunity test Compliance Level Electromagnetic environment – guidance
Test level

Portable and mobile RF communications

equipment should be used no closer to any part of
the Stella IQ, including cables, than recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1,2 √P
Conducted RF 3 Vrms d = 1,2 √P 80 MHz to 800 MHz
IEC 61000-4-6 150kHz to 80 Mhz 3 Vrms d = 2,3 √P 800 MHz to 2.5 GHz
where p is the maximum output power rating
Radiate RF 3 V/m 3 V/m
of the transmitter in watts (W) according to
IEC 61000-4-3 80 MHz to 2,5GHz the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey A,
should be less than the compliance level in each
frequency range B.
Interference may occur in the vicinity of equipment
marked with the following symbol:

• At 80 MHz and 800 MHz, the higher frequency applies.

• These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with
REGULATORY & WARRANTY

accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
INFORMATION

survey should be considered. If the measured field strength in the location in which the Stella System is used
exceeds the applicable RF compliance level above, the Stella System should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orientation or relocation of the Stella System.
Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.

55
EN60601-1-2:2007 (5.2.2.1) TABLE 4
Recommended separation distances between portable and mobile RF communications equipment
and the Stella System.

The Stella System is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The end user of the Stella System can help prevent electromagnetic interference by
maintaining a minimum distance between the portable and mobile RF communications equipment
(transmitters) and the Stella System as recommended below, according to the maximum output power
of the communications equipment.

Rated maximum Separation distance to frequency of transmitter – meters (m)

output power of 150 kHz to 80
transmitter 150 kHz to 80 MHz
MHz
Watts (W) d = 1.2 √P
d = 1.2 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distances
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

• At 80 MHz and 800 MHz, the higher frequency applies.

• These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures and people.

56
MANUFACTURER
Tristel Solutions Limited
Lynx Business Park,
Fordham Road
Snailwell,
Cambridgeshire
CB8 7NY
United Kingdom

T +44 (0)1638 721 500

F +44 (0)1638 721 911
E mail@tristel.com
W www.tristel.com

The Stella system is CE marked as a Class IIb

medical device as per the Medical Device Directive MDD
93/42/EEC and the 2007/47/ EC amendments thereto.

Tristel NV, Smallandlaan 14 B, 2660 Antwerp, Belgium

REGULATORY & WARRANTY

INFORMATION

STL/019/Issue 15

Copyright © 2019 Tristel Solutions Limited. All rights reserved.

For Tristel patent information please visit: http://www.our-patents.info/tristel

No part of this publication may be reproduced or transmitted, in any form or by any means, electronic,
mechanical, photocopying, recording or otherwise, or stored in a retrieval system of any nature without
the written permission of Tristel Solutions Limited.

57
 SECTION EIGHT
STELLA SERVICE AGENTS

58
SECTION 8: STELLA SERVICE AGENTS
AUSTRALASIA
NEW ZEALAND AUSTRALIA
Tristel New Zealand Limited Tristel Pty
23 Birch Avenue 40/328 Reserve Road
Judea, Tauranga Cheltenham, VIC 3192
New Zealand Australia
T +64 7 577 1560 T +1300 680 898
E info@tristel.co.nz E mail-au@tristel.com

EUROPE
UNITED KINGDOM & PORTUGAL SWEDEN
REST OF THE WORLD Teprel – Equipamentos Vingmed AB
Tristel Solutions Limited Médicos, S.A. Datavägen 9A
Lynx Business Park Adress: Rua D. Marcos da Cruz, SE-175 43
Fordham Road, Snailwell 1997 – 1º Poente Järfälla Sweden
Cambridgeshire, CB8 7NY, UK 4455-482 Perafita | Portugal T 08-583 593 00
T +44 (0)1638 721 500 T +351 22 999 9880 E info@vingmed.se
E mail@tristel.com E info@teprel.com
SLOVENIA
FRANCE REPUBLIC OF IRELAND Medip d.o.o.
Brennan & Company Taborska cesta 4
Ecomed Services
61 Birch Avenue 1290 Grosuplje
130, Boulevard de la Liberté
Stillorgan Industrial Park Slovenia
59000 Lille
Stillorgan, Co. Dublin T +386 3177 3989
France Republic of Ireland E info@medip.si
T +33 (0) 3 66 88 01 84 T +353 (1) 295 2501
E info@ecomed.eu E enquiries@brennanco.ie SPAIN
Vesismin S.L.
BENELUX RUSSIA Gran Via Carlos III nº 94
Ecomed Services Tristel International Ltd (Trade Buildings)
Smallandlaan 14B 5 Koloncova Street, West Tower, 5th floor - 3rd door
B-2660 Hoboken Mytishchi, 08028 Barcelona
Belgium Moscow region, 141009 Spain
T +32 (0)3 889 26 40 T +7 (495) 766-87-73 T +34 934 095 301
E info@ecomed.eu E info@tristelrussia.ru E vesismin@vesismin.com
GERMANY, AUSTRIA & SWITZERLAND DENMARK TURKEY
Tristel GmbH ViCare Medical A/S Yefe Dis Ticaret Ltd. Sti.
Karl-Marx-Allee 90A Birkerød Kongevej 150B Yesillik Cad. Selgecen Is Merkezi
Swinemünder Str. 110/111 DK-3460 Birkerød No:228-230 / 434 35380
10243 Berlin T +45 45 82 3366 Karabaglar, Izmir
T +49 (0)30 5484 4226 E info@vicare-medical.dk Turkey
E info@stella-performance.com T +90 232 264 19 23
FINLAND E info@yetaltd.com
ICELAND Otoplug Oy
Icepharma Osuusmyllynkatu 7 MALTA
Lyngháls 13 33700 Tampere, Associated Equipment
110 Reykjavík Finland Lourdes Square
Iceland T +358 40 5789 330 Rihan Avenue
T +354 540 4324 E otoplug@otoplug.fi San Gwann, SGN2010
E soley@icepharma.is Malta
NORWAY T (+356) 21384347
ITALY Vingmed AS E purchasing@
Solbråveien 13 associated-equipment.com
Tristel Italia S.r.l.
1383 ASKER
Via dei Mille, 10
Norway
20129 Milano
STELLA SERVICE AGENTS

T +47 67 58 06 80
T 02 83520915
E info@vingmed-as.no
E info@tristel.it

59
ASIA AND MIDDLE EAST
CHINA SINGAPORE
Tristel Medical Equipment (Shanghai) Co. Ltd EO Medical Pte. Ltd.
Room 912, JH Plaza 51 Ayer Rajah Crescent, #03-10/11
2008 Huqingping Road Singapore 139948
Quingpu District T +65 6100 5060
Shanghai 2017 , China E syloke@eo.com.sg
T +86 (21)8016 2555
E service@tristel.com.cn PAKISTAN
Strongman Medical Industries
HONG KONG 704/B Main Road Batala Colony
Tristel Asia Limited Faisalabad 38000
1802, 18F, World-Wide House Pakistan
19 Des Voeux Road, Central T +92 (41) 871 3751
Hong Kong E info@strongmanonline.com
T +852 3667 9253
E customerservice@tristel.com.hk SAUDI ARABIA
Cayane Economic
ISRAEL Office #39 - 2nd Floor
Sachar Medical Technologies Qortobah Commercial Center
7 Moshe Shwalb st. Arafat Street, Al-Harma Dist.
Segula Industrial Zone PO Box 126611
Petach Tiqwa Jeddah 21352
Israel T 00966 12 6132 283
T + 972(7)75513925 E info@cayane.net
E sachar.medtech@gmail.com
UNITED ARAB EMIRATES, BAHRAIN,
MALAYSIA KUWAIT, QATAR, OMAN & LEBANON
Schmidt BioMedTech Sdn Bhd Office no: 810-01
5th Floor Wisma Tecna 8th Floor, Platinum Tower,
18A, Jalan 51A/223 Cluster I, JLT, Dubai,
46100 Petaling Jaya, Selangor Darul Ehsan UAE
Malaysia T 00971 4 450 4838
T (852) 26208329 E info@cayane.net
E info@schmidtbmt.com

AFRICA
SOUTH AFRICA
BE SAFE PARAMEDICAL CC
58 Promenade Road
Muizenberg
Cape Town
7945
South Africa
T +27 (0) 21 788 4681
E info@be-safe.co.za

For all other areas, please contact our headquarters in the United Kingdom.

60
61
62