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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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
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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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
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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1electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
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