BANDELIN Trison 4000 User manual

Operating Instructions
6416h GB/2021-01
T4000
High-power ultrasonic bath
TRISON 4000 Xi R
Valid for all TRISON 4000 Si/Xi R/L and SONOBOARD TRISON R/L ultrasonic baths with software versions starting at 2.0.0 and images version 2.0.1

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Copyright & limitation of liability
This document may not be reproduced, whether in full or in part, without the prior approval of BANDELIN electronic GmbH & Co. KG,
hereinafter "BANDELIN".
The German-language original is the binding version of this document. Any differences in the translation are not binding and have
no legal effect. In case of any discrepancies between the translation and the original of this document, the original version will
take precedence.
BANDELIN accepts no responsibility or liability for damage caused by improper handling or usage contrary to the intended
purpose.
The documentation has been prepared with great care. Liability for indirect or direct damages arising because of incomplete or
erroneous information in this documentation, as well as in its delivery and usage, is excluded.
Brand note:
daVinci, Intuitive Surgical, EndoWrist Stapler, daVinci Si, daVinci Xi are registered trademarks of Intuitive Surgical Inc.
All illustrations are provided as examples and are not to scale. Decorative elements are not included in the scope of delivery.
Subject to technical alterations. Measurements are subject to manufacturing tolerances.
© 2021
1 2 GmbH & Co. KG, Heinrichstrasse 3 – 4, Germany, 12207 Berlin.
Tel.: [phone], Fax: [phone], [email protected]
(

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General
The device, the accessories and the agents are to be used in accordance with the
operating instructions and/or the product information.
The instructions are part of the scope of delivery and are to be stored near the device
for later reference. This also applies if the device is transferred to others.
Before the device is put into operation, these instructions are to be read carefully and
completely in order for the user to become familiarised with all functions.
The warnings and safety precautions (Section 1.9) are always to be followed during
use.
The manufacturer will not assume any responsibility for the device's safety or proper
functioning in the event of improper handling or usage contrary to the intended
purpose. Unauthorised alterations/modifications will render both the warranty claim and
the CE conformity null and void.
If service is required, please contact the authorised specialist dealer, customer service,
or the manufacturer.
Symbols used:
Symbol Meaning Explanation
Danger Denotes information that, if not observed, could pose a risk to
life and limb, especially from electric shock.
Caution
Denotes information that must be observed and complied with
in order to prevent damage to the device or injury to the user.
When device parts are labelled with this symbol, the
documentation must be observed.
Important Identifies information that is important for execution.
Note Identifies explanatory information.
Medical note Identifies information that is important for medical use.
Do not reach inside For health reasons, touching the oscillating liquid is prohibited.
Wear hearing
protection
For health reasons, spending long periods of time in the
vicinity of the device without hearing protection is prohibited.
Instructions Identifies instructions that must be followed in the described
sequence.

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Table of Contents
1 Product description ......................................................................................................8
1.1 TRISON Base control unit ............................................................................................8
1.2 Ultrasonic oscillating tank with ultrasound generator .................................................10
1.3 Special accessories ...................................................................................................11
1.3.1 TRISON Lift pivot-mounted arm for TRISON Twist ....................................................11
1.3.2 TRISON Twist moving device for robotic instruments ................................................11
1.3.3 TRISON Rack special basket for MIS instruments ....................................................13
1.3.4 Temperature sensor ...................................................................................................14
1.3.5 Twist spacer Xi ...........................................................................................................14
1.4 SONOBOARD TRISON functional cabinet ................................................................15
1.5 Mode of operation ......................................................................................................16
1.6 Intended purpose .......................................................................................................17
1.6.1 Use of the devices........................................................................................................17
1.6.2 Indications, contraindications, side effects of the devices............................................18
1.6.2.1 Indications/areas of application....................................................................................18
1.6.2.2 Contraindications/exclusions........................................................................................18
1.6.2.3 Possible side effects/limitations ...................................................................................19
1.6.3 User group ..................................................................................................................19
1.7 CE conformity .............................................................................................................19
1.8 Technical data ............................................................................................................20
1.8.1 Degrees of protection according to DIN EN 60529 ....................................................25
1.8.2 Electromagnetic compatibility (EMC) .........................................................................25
1.9 Warnings and safety instructions ...............................................................................26

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2 Preparation .................................................................................................................28
2.1 Scope of delivery ........................................................................................................28
2.2 Setup/assembly ..........................................................................................................28
2.3 Commissioning and basic settings .............................................................................29
2.3.1 Basic settings .............................................................................................................29
2.3.2 Additional user settings ..............................................................................................31
3 Operation ...................................................................................................................32
3.1 Operating elements ....................................................................................................32
3.2 Signals on the touchscreen ........................................................................................36
3.3 Connection/removal of the instruments ......................................................................37
3.3.1 Robotic instruments ...................................................................................................37
3.3.1.1 Connection of Si instruments to the TRISON Twist TT 4000 Si .................................38
3.3.1.2 Connection of Xi instruments to the TRISON Twist TT 4000 Xi .................................40
3.3.2 Rinsable MIS instruments ..........................................................................................42
3.3.3 Establishing connections to the TRISON Base ..........................................................44
3.4 Connecting/removing the adapter testing strips .........................................................45
3.5 Opening and closing the outlet ...................................................................................45
3.6 Attachment/removal of the TRISON Lift .....................................................................46
3.7 Mounting/removal of the TRISON Twist .....................................................................47
3.8 Protocols ....................................................................................................................48
3.8.1 Opening and closing of the USB interface .................................................................48
3.8.2 Copying/retrieving protocols via USB interface ..........................................................49
3.8.3 Copying/retrieving protocols via Ethernet interface ....................................................49

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3.9 Connecting/analysing the temperature sensor ...........................................................51
4 Application ..................................................................................................................52
4.1 Start – preparation of the ultrasonic bath ...................................................................52
4.2 Cleaning .....................................................................................................................54
4.2.1 Robotic instruments ...................................................................................................54
4.2.2 MIS instruments ..........................................................................................................55
4.2.3 Standard instruments .................................................................................................57
4.3 Completion – post-processing of the ultrasonic bath .................................................58
5 Cleaning and maintenance of the ultrasonic bath ......................................................60
5.1 Cleaning and care ......................................................................................................60
5.2 Disinfection .................................................................................................................61
5.3 Warehousing/storage .................................................................................................61
6 Maintenance and repair .............................................................................................62
6.1 Maintenance ...............................................................................................................62
6.1.1 Replacing filter cartridge ............................................................................................63
6.1.2 Replacing the adapter seal (TRISON Rack) ..............................................................64
6.2 Function checks .........................................................................................................65
6.3 Malfunction/fault analysis ...........................................................................................66
6.4 Repairs and service ...................................................................................................69
6.4.1 Customer service .......................................................................................................69
6.4.2 Certificate of Decontamination ...................................................................................70
6.4.3 Replacing fuses ...........................................................................................................70
6.4.4 Determining the software version ...............................................................................70
7 Accessories ................................................................................................................71
7.1 Required accessories .................................................................................................71

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Informative annexes
A Foil test
B Maintenance lists
C Screen displays
7.2 Optional accessories ..................................................................................................72
7.3 Agents ........................................................................................................................73
7.3.1 STAMMOPUR DR 8
Disinfection and cleaning agent .................................................................................74
7.3.2 STAMMOPUR R
instrument cleaner ......................................................................................................75
8 Consumable materials ...............................................................................................76
9 Decommissioning .......................................................................................................77
10 Keyword index – not applicable – ..............................................................................77

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1 Product description
The TRISON ultrasonic tank primarily consists of the TRISON Base control unit, the
ultrasonic oscillating tank, and the ultrasound generator.
The mains connection is made via the mains supply switch.
Special accessories or other inset beakers are also required for operation.
The TRISON ultrasonic bath is also available as a ready-to-use "SONOBOARD
TRISON" set in a functional cabinet.
In the following, the term "TRISON ultrasonic bath" will stand for both the model to be
mounted in an existing work plate and also for the "SONOBOARD TRISON" ready-to-
use set.
1.1 TRISON Base control unit
TRISON Base TB 4000 R/L control unit with rinsing function for robotic and MIS
instruments. The base is available in both right- and left-handed variants, as indicated
by the letters "R" or "L" in the type designation.
The exact type specification and serial number are found on the type plate.
Product features:
• Touchscreen (1)
• Easy-to-clean plastic housing (2a) atop a rotary base (2b)
• Replaceable filter (3) for capturing dislodged contamination
• Connectors (4) for hose couplings (TRISON Twist & Rack)
• Connector for TRISON Twist (5) or temperature sensor
• USB interface (6a) and Ethernet interface (6b) for logging
• Mains switch (7)
• Fuses (8)
• Connectors for compressed air (9a) and electricity (9b)
• Mains supply switch (10) for setting on a level surface or for suspension, with
connectors for the mains (10a), TRISON Base (10b), ultrasound generator (10c),
and a second ST control unit if required (10d)

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78
6b
Based on example of a
TRISON Base TB 4000 R
1010b
10a
10d
10c
Mains supply switch
NW 3000
9a
9b
2a
2b
4
5
1
3
6a
AB

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1.2 Ultrasonic oscillating tank with ultrasound generator
The TE 3000 ultrasonic oscillating tank has been especially developed and adapted for
robotic instruments. A specially adapted ultrasound generator GT 3000 M-C is supplied
for operation of the tank.
The exact type specification and serial number are found on the type plate.
Product features:
• Stainless steel oscillating tank with transducer on the tank bottom and side,
ultrasonic frequency 38 kHz
• Filling level mark for safe filling (11)
• Basket mounts (12) for special accessories
• Outlet for drain set to enable fast draining of the bath liquid (13)
• Ultrasound generator (14) for setting on a level surface or for suspension, with mains
panel connector (14a) for mains cable, and HF connection (14b) for TE 3000
Back
14b
14a
13
12
11
TE 3000
14
GT 3000 M-C

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1.3 Special accessories
Special accessories have been developed to fit in the ultrasonic bath, customised to the
respective application:
TRISON Twist with pivot-mounted arm, TRISON Lift for robotic instruments, and
TRISON Rack for MIS instruments.
1.3.1 TRISON Lift pivot-mounted arm for TRISON Twist
The TRISON Twist for robotic instruments can be swivelled
into the oscillating tank using the TRISON Lift TL 4000 pivot-
mounted arm, which is mounted on the work surface behind the
ultrasonic oscillating tank.
It can be used together with the TRISON Twist Si and Xi.
Product features:
• Head section (1) with guide and rack for both TRISON Twists
• Base (2) with guide for affixing to the base plate (3),
firmly screwed-in to the work plate
1.3.2 TRISON Twist moving device for robotic instruments
With its special mounts, the TRISON Twist TT 4000 Si or Xi moving device can
accommodate up to 4 Si or Xi robotic instruments and turn the instrument tips at the
same time as they are being rinsed. This means that all surfaces/joints/cavities are
cleaned, even those that are hard to reach by hand. The Twist is available in both left-
handed and right-handed versions (matching the TRISON Base).
The exact type specification and serial number are found on the type plate.
Product features for TT 4000 Si and TT 4000 Xi:
• 4 mounts for the corresponding instruments, with push handles for the TT 4000 Si
(1a), and with guiding pins for the TT 4000 Xi (1b)
• Bearings (2) suitable for the ultrasonic oscillating tank (only for Si)
• Plug (3) for connection to the TRISON Base
• Connector (4) with guide for affixing to the TRISON Lift
• Handle (5) and legs (6)
• Hose set (7) with rinsing plugs (7a), couplings (7b) for connection to the TRISON
Base and return flow (7c) with lowering weight
1
2
3

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TT 4000 Xi for Xi robotic instruments
TT 4000 Si for Si robotic instruments
7b
7
7a
7c
2
1a
3
4
5
6 (not visible)
6
3
4
5
1b
7
7a
7c
7b

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1.3.3 TRISON Rack special basket for MIS instruments
The TRISON Rack TR 3001 R special basket can accommodate up to 8 MIS
instruments thanks to its special comb.
It is available in both right- and left-handed variants, as indicated by the letters "R" or
"L" in the type designation.
Product features:
• Basket (1) with comb bar (1a) and handles (1b)
• Bearings (2) suitable for the ultrasonic oscillating tank
• 8 adapters (3) to connect the instruments, detachable from the comb bar
• Hose set (4) with couplings (4a) to connect to the TRISON Base and return flow (4b)
with lowering weight
2
2
4a
4
1b
1a 1
3
4b
TRISON Rack
TR 3001 L
TRISON Rack
TR 3001 R

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1.3.4 Temperature sensor
The temperature sensor TM 4000 is used for monitoring the temperature of the bath
liquid during cleaning of standard instruments (program: Standard).
It is plugged into a basket holder of the on the drain side of the oscillating tank and
connected to the TRISON Base for power supply.
Product features:
• Sensor immersion sleeve (1)
• Clamp (2) for attachment to a basket
mount of the oscillating tank
• LED display (3)
• Plug (4) for connection to
the TRISON Base
1.3.5 Twist spacer Xi
The spacers are accessories for the TRISON Twist 4000 Xi when cleaning EndoWrist
Xi Staplers.
2 spacers in the scope of delivery.
The spacers are attached to the feet of the TRISON Twist Xi and thus raise positioning
of the Twist. This prevents possible contact between the instruments and the tank
bottom, thus preventing damage.
Product features:
• Clip (1) for attachment to the Twist
• Handle (2) for easier handling
• Feet (3)
3
4
1
2
2
3
3
1

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1.4 SONOBOARD TRISON functional cabinet
The SONOBOARD functional cabinet is available in both right- and left-handed
variants, as indicated by the letters "R" or "L" in the type designation.
Product features:
• Stable, easy-care stainless steel body (1)
• Easy-care stainless steel work plate with upstand (2)
• Double-walled doors (3)
• Easy-run swivel-casters (4), with locking brakes at the front
• Recess for utility connections (5) in rear wall
5
1
2
4
3
Based on example of a
SONOBOARD TRISON R

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1.5 Mode of operation
Principle of ultrasonic cleaning
TRISON ultrasonic baths use the effect of cavitation. They contain piezoelectric
transducers under their tank bottoms and additionally on the tank wall, the energy of
which is transferred to the bath liquid as mechanical oscillations at ultrasonic frequency.
As a result, microscopically small bubbles are continuously formed in the bath liquid,
releasing energy upon imploding and generating local microcurrents. This process
is called cavitation. During the cleaning process, this causes contamination to be
positively blasted from the hard surfaces of the objects being treated. At the same time,
dirt particles are dispersed and fresh bath liquid flows in.
TRISON ultrasonic baths are efficiently supported by SweepTec automatic frequency
control. SweepTec immediately balances load-dependent working point fluctuations
using fast frequency modulation around the optimal working point. This produces an
especially homogeneous and uniform ultrasound field in the bath volume for constantly
reproducible results.
Cleaning, rinsing and movement of robotic instruments in the TRISON Twist
On the TRISON Twist, up to 4 robotic instruments with diameters of 5 or 8 mm can
be rinsed on the inside and simultaneously moved at their tips during sonication.
The instruments are snapped onto the TRISON Twist and each of them is connected
through two hoses to the TRISON Base's rinsing circuit.
The cleaning program first conducts a filling and soaking of the instruments for 30
minutes, using a cleaning agent, in order to loosen up or dissolve organic residue. The
control housing and shaft of each instrument are rinsed and tested for flow-through in
subsequent ultrasonic cleaning. Instruments that were not rinsable during the cleaning
process, e.g. due to clogging, are reliably identified by the integrated continuity test and
specified on the monitor.
The sonication time is permanently programmed for 30 min.
Cleaning and rinsing of MIS instruments/cleaning of standard instruments in the
TRISON Rack
During sonication, up to 8 rinsable MIS instruments with exterior diameters of 3 to 10
mm can be rinsed from the inside in the TRISON Rack. Each instrument is hooked up
to its assigned adapter and connected to the rinsing cycle of the TRISON Base. Rinsing
is conducted using a suction process at the distal end of the instruments. Soiling is
always evacuated in the direction opposite to that in which it entered. The remaining
lumen of the respective instruments is not contaminated any further by this soiling. The
interior of the shaft of every instrument is rinsed and tested individually for flow-through.
Instruments that were not rinsable during the cleaning process, e.g. due to clogging,
are reliably identified by the integrated continuity test and specified on the monitor.
"Non-continuity" of an instrument is declared if the flow-through rate is less than 2 ml/s.

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Non-rinsable standard instruments such as scissors and forceps are placed in the
TRISON Rack or a similar basket and are not connected to the adapters – the adapters
remain open.
The sonication time for each instrument can be set by the user according to the
cleaning and/or disinfection agent used (default value 15 min).
TRISON functional diagram:
Channel
selector
Switch
Coupling A
Coupling B
Pump Pressure
switch
Pressure
switch
Filter Flow rate sensor
Oscillating tank
P
P
1.6 Intended purpose
1.6.1 Use of the devices
TRISON ultrasonic baths use the physical effect of high-frequency ultrasound in
aqueous liquids in order to clean re-processable medical instruments. Their main
application is the gentle, intensive cleaning of rinsable robotic and MIS instruments.
Simple standard instruments can also be effectively cleaned in ultrasonic baths.
Sonication is conducted using water and an agent suitable for use with ultrasound.
In order to use the device as intended, an ultrasound-permeable insert basket or an
appliance suitable for positioning the instruments during sonication is also required.
IMPORTANT!
Ultrasonic baths are operated in the context of further steps required to meet the
requirements for hygiene in the reprocessing of medical devices in accordance with
applicable national regulations. TRISON ultrasonic baths are class I medical devices in
accordance with Directive 93/42/EEC and must be operated accordingly.

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1.6.2 Indications, contraindications, side effects of the devices
1.6.2.1 Indications/areas of application
• Physically, TRISON ultrasonic baths are especially suited for the cleaning of objects
made of metal, glass or hard plastics. Hard-to-access spots, surfaces, corners and
openings can be conveniently reached through ultrasound.
• Medical instruments can be cleaned by TRISON ultrasonic baths as part of manual
processing, and before or after machine processing, with:
o Sonication and simultaneous rinsing of the instrument shafts, as well as
simultaneous movement of the instrument tools for daVinci Si/daVinci Xi robotic
instruments using the TRISON Twist
o Sonication and simultaneous rinsing of instrument shafts for MIS instruments
with outer diameters of 3 to 10 mm using the TRISON Rack
o Sonication of standard instruments in suitable baskets/devices
• The information supplied by the instrument manufacturer specifies whether the
instruments are suited for ultrasonic cleaning.
1.6.2.2 Contraindications/exclusions
• Lenses, camera systems, light cables, mirrors, or objects made of or containing
elastic materials (e.g. catheters, respiratory system functional parts, flexible
endoscopes) are not suitable for sonication, or are only suitable under certain
conditions. The information supplied by the instrument manufacturer specifies
whether the instruments are suited for ultrasonic cleaning.
• TRISON ultrasonic baths are not suitable for cleaning and/or disinfection of contact
lenses.
• The sonication of combustible liquids in TRISON ultrasonic baths is not permitted.
• Indirect sonication is not permitted in TRISON ultrasonic baths.
• Wearers of medical implants (e.g. implants with electrical or electromotor function)
must observe the safety instructions in Section 1.8.
Note:
Pregnancy is not a contraindication for the use/operation of ultrasonic baths.

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1.6.2.3 Possible side effects/limitations
• Processes such as chemical disinfection can be accelerated (time-shortened) in
TRISON ultrasonic baths. Ultrasound alone does not disinfect.
• Cavitation erosion can cause surfaces to be mechanically corroded and their
coatings to dissolve.
• In case of steam formation, the TRISON ultrasonic baths must be operated with a lid.
• Ultrasound warms up the bath liquid even without additional heating.
1.6.3 User group
TRISON ultrasonic baths are intended for commercial use, e.g. in a treatment unit for
medical devices (AEMP). The ultrasonic baths must be used by medical or equivalent
skilled personnel.
1.7 CE conformity
The ultrasonic bath is declared as a medical device and satisfies the CE-marked
criteria for the European directives:
– Medical Device Directive
– Low-Voltage Directive
– Electromagnetic Compatibility Directive
– RoHS Directive
in their currently valid versions.
A declaration of conformity can be requested from the manufacturer by providing the
serial number.

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1.8 Technical data
The ultrasonic bath is interference-free and marked with CE.
Safety: EN 61010-1,
EMC: EN 61326-1
Ambient conditions pursuant to EN 61 010-1
Overvoltage category: II
Degree of contamination: 2
Permissible ambient temperature: 15 to 35°C
Permissible relative humidity up to 31°C 80%
Permissible relative humidity up to 40°C: 50 %
Altitude: up to 2,000 m above sea level
No condensation allowed.
For indoor operation only.
Specifications for use as a medical device
Name: Ultrasonic bath
UMDNS nomenclature (ECRI/DIMDI): 14-263
Purpose: see Section 1.6.
Classification (pursuant to Medical Devices
Directive 93/42/EEC, Annex IX):
Class I; active, non-invasive,
non-implantable medical device
Type, model, serial number, year of manufacture: See type plates for information
The ultrasonic bath has been inspected according to applicable standards and must be
installed and operated according to EMC directions; see Section 1.8.2.
Specifications pursuant to the German Medical Devices Operator Ordinance
(MPBetreibV):
On-site commissioning, function check and
personnel instruction (§ 4): not required
Technical safety control (STK) (§ 11): Every 2 years by the manufacturer or
authorised skilled personnel
(DIN EN 62353/VDE 0750)
Technical measurement controls (§ 14): N/A