BANDELIN TRISON Manual de usuario

6536-000 en/2022-03

Operating Instructions

TRISON

High-power ultrasonic bath

Valid for:

TRISON 4000 Si/Xi R/L

SONOBOARD TRISON R/L

Software version from 2.0.0, image version 2.0.1

Dokument:6536-000Sprache: enVersion:2022-03

2/54 6536-000 en/2022-03

1 2 GmbH & Co. KG, Heinrichstr. 3–4, 12207 Berlin, Ger-

many

Phone: +49 30 76880-0, Fax: +49 30 7734699, [email protected]

Certified in accordance with ISO 9001 and ISO 13485

The product names da Vinci, da Vinci Xi and da Vinci Si, as well as da Vinci

EndoWrist, are trademarks or registered trademarks of Intuitive Surgical or their

respective owners.

6536-000 en/2022-03 3/54

Table of contents

1 About this operating manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2 Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

2.1 Using the ultrasonic bath . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

2.2 Reporting obligation in the event of serious incidents. . . . . . . . . . . 7

2.3 Prevention of cross-contamination and infection. . . . . . . . . . . . . . . 7

2.4 Keep away from children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2.5 Danger of electric shock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.6 Damage to health due to ultrasonic noise. . . . . . . . . . . . . . . . . . . . . . 8

2.7 Hazards due to high temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.8 Danger from ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.9 Danger from agents used. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.10 Disposing of sonication fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.11 Erosion of the oscillating tank. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2.12 Interference with wireless communication. . . . . . . . . . . . . . . . . . . . . 10

3 Design and function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.2 Oscillating tank with ultrasound generator. . . . . . . . . . . . . . . . . . . . . 12

3.3 TRISON Base control unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.4 TRISON Lift . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.5 TRISON Twist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.6 TRISON Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

3.7 Temperature sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3.8 Xi spacer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3.9 Symbols and buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4 Preparation for operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4.1 Rinsing out the ultrasonic oscillating tank. . . . . . . . . . . . . . . . . . . . . . 17

4.2 Switching the ultrasonic bath on and off. . . . . . . . . . . . . . . . . . . . . . . 17

4.3 Changing settings on the TRISON Base . . . . . . . . . . . . . . . . . . . . . . . . 18

4.4 Attaching and removing the TRISON Lift . . . . . . . . . . . . . . . . . . . . . . . 18

4.5 Attaching and removing the TRISON Twist . . . . . . . . . . . . . . . . . . . . . 19

5 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Table of contents

4/54 6536-000 en/2022-03

5.1 Preparing for ultrasonic cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.1.1 Sonication fluid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.1.2 Pour in the sonication fluid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

5.1.3 Degas the sonication fluid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

5.1.4 Checking the adapters for MIS instruments . . . . . . . . . . . . . . . . . . . . 22

5.2 Cleaning instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5.2.1 Cleaning the Si instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

5.2.2 Cleaning the Xi instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

5.2.3 Cleaning rinsable MIS instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

5.2.4 Cleaning standard instruments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

5.3 After the ultrasonic cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

5.3.1 Empty the oscillating tank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

5.3.2 Rinsing the ultrasonic bath. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

5.3.3 Disinfecting the ultrasonic bath . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

5.3.4 Cleaning and disinfecting the TRISON Lift, TRISON Twist and TRISON Rack 29

5.3.5 Rinsing the filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

5.3.6 Saving of logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

5.4 Troubleshooting a malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

6 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

6.1 Cleaning and maintenance of the ultrasonic bath . . . . . . . . . . . . . . . 35

6.2 Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

6.3 Replacing the adapter seals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

6.4 Performing the foil test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

6.5 Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

6.6 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

7 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

8 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

9 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

10 Process diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

11 Maintenance lists. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

6536-000 en/2022-03 5/54

About this operating manual/1

1 About this operating manual

This operating manual contains important and useful information for safe and

efficient use of the ultrasonic bath.

• Please read this operating manual before using the ultrasonic bath.

• In particular, please observe chapter 2Safety.

• If you pass on this ultrasonic bath, include this operating manual.

• Contact your specialist dealer or BANDELIN if you have any questions that are

not answered in this operating manual. You will find information on our ser-

vice department in chapter 6.5Repair.

Illustrations are examples and not to scale.

Safety

6/54 6536-000 en/2022-03

2Safety

2.1 Using the ultrasonic bath

The TRISON ultrasonic bath uses the physical effect of high-performance ultra-

sound in aqueous liquids to clean rinsable and non-rinsable medical instruments.

The TRISON ultrasonic bath is a Class I medical device pursuant to Regulation (EU)

2017/745.

UMDNS nomenclature (ECRI/DIMDI): 14-263

Cleaning is conducted using water and an agent suitable for use with ultrasound.

The use of the TRISON ultrasonic bath is indicated for

• Support for manual pre-cleaning in the context of mechanical reprocessing of

medical devices and as

• Support for manual pre-cleaning and cleaning in the context of manual repro-

cessing of medical devices.

Instruments may not be placed on the bottom of the oscillating tank. They must

be inserted into the sonication fluid with a TRISON Twist, in a TRISON Rack or an

insert basket with basket holder. An overview of suitable accessories can be

found in chapter 9Accessories.

The TRISON ultrasonic bath may not be operated while unattended.

Intended purpose

The TRISON ultrasonic bath can be used for the following purposes:

Contraindications/exclusions

• Lenses, camera systems, light cables, mirrors, or objects made of or contain-

ing elastic materials (e.g. catheters, respiratory system functional parts, flexi-

ble endoscopes) are not suitable for sonication, or are only suitable under

Purpose (cleaning goal) Required accessories

Sonication and simultaneous, alternating suction and pressure

rinsing of the instrument shafts while the instrument tools of

the da Vinci Si robotic instruments move

TRISON Twist Si

Right variant or left variant

Sonication and simultaneous, alternating suction and pressure

rinsing of the instrument shafts while the instrument tools of

the da Vinci Xi robotic instruments move

Cleaning of the da Vinci Xi EndoWrist Staplers 45

TRISON Twist Xi

Right variant or left variant

Additional Xi spacer

Sonication and simultaneous suction rinsing of the instrument

shafts of MIS instruments with outer diameters of 3 to 10 mm

TRISON Rack

Right variant or left variant

Sonication of standard instruments Insert basket and

basket holder

Right variant or left variant

6536-000 en/2022-03 7/54

Safety/2

certain conditions. The specifications of the respective manufacturer provide

information on suitability for ultrasonic cleaning.

• The TRISON ultrasonic bath is not suitable for cleaning or disinfecting contact

lenses.

• Flammable liquids may not be sonicated in the TRISON ultrasonic bath.

• Indirect sonication in the TRISON ultrasonic bath is not permitted.

Possible side effects/restrictions

• Ultrasound does not disinfect. However, processes such as chemical disinfec-

tion may be accelerated in the ultrasonic bath.

• Cavitation erosion can cause surfaces to be mechanically corroded and their

coatings to dissolve.

User group

The TRISON ultrasonic bath is intended for use in health care facilities, e.g. in a

Central Sterile Supply Department (CSSD). It is to be used by trained personnel.

Operating the ultrasonic bath does not pose a risk to pregnant women.

2.2 Reporting obligation in the event of serious incidents

Report serious incidents to BANDELIN electronic GmbH and Co. KG and to the

competent authorities.

2.3 Prevention of cross-contamination and infection

To avoid cross-contamination, regularly clean and disinfect the surfaces of the

ultrasonic bath with a surface disinfectant that has at least bactericidal, yeasti-

cidal and limited virucidal properties. Process accessories such as holders, carri-

ers or baskets in a cleaning and disinfection device.

At higher temperatures, vapours and aerosols that are contaminated with intro-

duced impurities may escape from the ultrasonic bath. This can lead to infections

and disease. Avoid bath temperatures above 40 °C. If necessary, use a lid, suction

device or protective equipment.

2.4 Keep away from children

Children cannot see the dangers related to the ultrasonic bath. Therefore, keep

children away from the ultrasonic bath.

Safety

8/54 6536-000 en/2022-03

2.5 Danger of electric shock

The ultrasonic bath is an electrical device. Failure to follow safety rules can result

in a life-threatening electric shock.

• Protect the ultrasonic bath from moisture and wetness. Keep the surface and

the touchscreen clean and dry.

• Only transport the ultrasonic bath in empty condition.

• Do not spray the ultrasonic bath, do not immerse it in water or expose it to

splash water.

• Only connect the ultrasonic bath to a power outlet with a grounded socket.

• If you notice a defect in the ultrasonic bath, disconnect the mains plug imme-

diately. Do not connect a defective ultrasonic bath to the mains.

• Repairs should only be carried out by the manufacturer. See chapter

6.5Repair.

• Position the ultrasonic bath so that it is easy to unplug the mains connection.

2.6 Damage to health due to ultrasonic noise

Some people may find the typical ultrasonic noise produced during processing

very unpleasant. Damage to health can result if you remain within a radius of 2 m

for long periods.

• Wear suitable ear protection.

• Use a lid to reduce noise. The ultrasonic bath can also be used inside a sound-

proof box.

2.7 Hazards due to high temperature

The ultrasonic bath, sonication fluid and instruments can become hot during

operation. Contact with these products may cause burns.

Ultrasound energy warms up the sonication fluid even without additional heating.

Prolonged ultrasound operation can lead to very high temperatures.

• Observe the treatment times recommended by the manufacturer of the ultra-

sound preparation. Do not leave the ultrasound switched on for longer than

necessary.

• Do not reach into the sonication fluid with your hand. Remove instruments

with the TRISON Twist, the TRISON Rack, the insert basket or forceps.

• Allow instruments to cool before touching them.

Non-aqueous fluids can heat up many times faster than water. A possible flash-

point can be reached or exceeded after a very short sonication time. In the case of

high-boiling liquids, the bath temperature can rise to over 120 °C due to the

energy input of the ultrasound. This can lead to fires and severe burns.

6536-000 en/2022-03 9/54

Safety/2

2.8 Danger from ultrasound

High ultrasonic levels like those reached in the ultrasonic bath destroy cell struc-

tures. If part of the body is immersed in the sonication fluid during operation, this

can cause damage to skin and also damage to internal tissue. The periosteum of

finger bones can be damaged.

• Do not reach into the sonication fluid during operation.

• Never sonicate living creatures.

2.9 Danger from agents used

Agents used in the ultrasonic bath can be toxic or caustic. They can irritate eyes,

skin and mucous membranes. The vapours and aerosols can also be dangerous.

• Wear gloves and protective goggles when handling dangerous agents.

• Do not ingest the agents and do not allow them to come into contact with

eyes or skin. Do not lean closely over the ultrasonic bath otherwise vapours

could come into contact with your eyes and you could breathe in vapours.

• Place a lid on the ultrasonic bath during operation. Use an extraction system if

there are dangerous vapours.

• Note the information on the label and on the safety data sheet for the agent.

• Keep the agents out of the reach of children and of persons who have not

been instructed.

2.10 Disposing of sonication fluid

Dispose of the sonication fluid according to the information provided by the man-

ufacturer of the ultrasound agents used. The recommended ultrasound agents

from the TICKOPUR, TICKOMED and STAMMOPUR product ranges from

DR. H. STAMM GmbH are biodegradable according to the articles of Regulation

(EC) no. 648/2004 (Detergents Regulation). If necessary, the sonication fluid

needs to be neutralised before disposal.

During cleaning, water-polluting substances, e.g. oils or heavy-metal compounds,

can contaminate the sonication fluid depending on the type of soiling. If the limit

value for these substances is exceeded, the sonication fluid must be reprocessed

or disposed of as special waste.

Observe the local waste water regulations.

Safety

10/54 6536-000 en/2022-03

2.11 Erosion of the oscillating tank

The surface of the oscillating tank is subject to erosion. How quickly this erosion

takes place depends on the use of the ultrasonic bath. The erosion leads to leak-

age in the oscillating tank. Bath liquid can thus penetrate into the interior of the

ultrasonic bath. Moisture on electrical components can cause an electric shock or

fire.

• Do not use the ultrasonic bath any longer if you notice a leak. Disconnect the

mains plug immediately. Empty the oscillating tank.

You can extend the lifespan of the oscillating tank by observing the following

instructions:

• Replace any sonication fluid that is visibly contaminated with particles.

• Only use demineralised water (DI water) with an ultrasound-compatible

preparation.

• Do not use chemicals that contain or release chloride ions in the oscillating

tank. This is the case with some disinfectants, household cleaners and dish-

washing detergents. Chloride ions will corrode stainless steel.

• Only use the ultrasonic bath with accessories that are suited for the ultrasonic

bath and instruments. Do not place any instruments directly on the bottom of

the oscillating tank. An overview of suitable accessories can be found in chap-

ter 9Accessories.

2.12 Interference with wireless communication

The ultrasonic bath can cause interference in nearby wireless communication

devices, e.g.:

• Mobile phones

• WiFi devices

• Bluetooth devices

If interference with the functions of a wireless device occurs, increase its distance

from the ultrasonic bath.

The ultrasonic bath meets the requirements for Class B devices according to EN

55011.

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