Swiss LithoClast Trilogy Instructions for Use Rev A-01 Sept 2017

Please Read this First! We would be pleased to answer your questions and we welcome your suggestions. We do, of course, provide support in case of technical problems. Please contact your local Boston Scientific sales representatives. We wish you lots of success! About this Manual Please note that the English version of this manual is the source from which all translations are derived. In case of any discrepancy, the binding version is the English text. These operating instructions are to ensure the correct installation and use of this product. Always keep these instructions close at hand. Please read these operating instructions carefully as they explain important details and procedures. Please pay special attention to the safety precautions. Any serious incident that has occurred in relation to the product should be reported to the manufacturer and the competent authority. To prevent injury to people and damage to property, please follow the corresponding directives. They are marked as indicated: Warning: Risk of severe injuries for patient or user Caution: Risk of patient or user injury. Risk of damaging the product or environmental harm Note: Useful additional information and hints.

Intended Use The product is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

Intended User The product must be used by qualified operating room personnel (with extensive training in urology) in hospitals, clinics and medical universities to treat affected patients of any age. It is intended to be reprocessed by trained reprocessing personnel, biomedical services, or by an external reprocessing contractor. Contraindications and Patient Population Use of the product is contraindicated in patients with any of the following conditions: •

Active bleeding disorders,

•

Solitary functioning kidney,

•

Creatinine greater than or equal to 3 µg %,

•

During pregnancy,

•

Stricture and obstruction problems,

•

An implanted electrical stimulator (e.g. pacemaker).

•

Under the age of 18

Potential Complications Potential complications associated with fragmentation of urinary tract calculi by ballistic and/or ultrasound energy include: •

Perforation,

•

Hemorrhage,

•

Lesion,

•

Stone migration,

•

Pain/colic,

•

Macroscopic hematuria,

•

Infection,

•

Ureteral obstruction.

Operating mode The product can deliver ultrasound and ballistic energies through a single probe simultaneously, or separately to fragment stones. The product can extract stone fragments through the probe while delivering energy or without delivering energy. The product is able to collect the stone fragments for analysis.

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CONTENTS 1. WARNING

5

2. COMPONENTS

7

3. INSTALLATION

9

3.1. INSTALLING THE CONSOLE 

9

3.2. FILLING THE COOLING SYSTEM  3.3. CONNECTING THE CONSOLE TO THE EQUIPOTENTIAL CONDUCTOR

6.7. DISPOSING OF SINGLE-USE COMPONENTS26 6.8. SWITCHING OFF THE CONSOLE

26

9

7. CLEANING, DISINFECTING, AND STERILIZING

27

11

7.1. MULTIUSE COMPONENTS

27

7.2. CONSOLE, PEDAL, AND CART

29

8. PRODUCT MAINTENANCE

30

3.4. CONNECTING THE VIDEO CORD (OPTIONAL)11 3.5. INSTALLING THE PEDAL 

12

3.6. INSTALLING THE STONE CATCHER 

12

3.7. INSTALLING THE SINGLE-USE FLUID MANAGEMENT SYSTEM SET (OPTIONAL) AND REPLACEMENT POUCH  14

8.1. COOLING LIQUID CIRCUIT MAINTENANCE 30 8.2. REPLACING FUSES 

31

8.3. DOWNLOADING LOGFILE

31

9. PRODUCT STORAGE AND SHIPPING

32

3.8. CONNECTING THE STERILIZED HANDPIECE TO THE CONSOLE 

14

3.9. INSTALLING A PROBE ON THE HANDPIECE 

9.1. EMPTYING THE COOLING LIQUID CIRCUIT 32

15

9.2. SHIPPING THE PRODUCT

33

3.10. CONNECTING THE POWER CORD

15

10. PRODUCT DISPOSAL

34

4. GETTING STARTED

16

11. TECHNICAL SUPPORT

34

4.1. STARTING THE DEVICE 

16

12. TROUBLESHOOTING

35

4.2. ADJUSTING THE PARAMETERS

16

12.1. MANUAL HANDPIECE UNLOCKING

35

4.3. EQUIPMENT DATA

18

12.2. WEAK SUCTION

35

5. TREATMENT

19

5.1. FUNCTIONAL TESTS

19

5.2. PROBE INSERTION

20

5.3. TREATMENT SETTINGS

20

5.4. ADAPTING SUCTION FLOW RATE

22

5.5. STARTING TREATMENT

22

6. POST-TREATMENT PROCEDURE

23

6.1. COMPLETING TREATMENT

12.3. PROBE NOT COMPATIBLE WITH THE ENDOSCOPE35 12.4. DISPLAYED ERROR MESSAGES 

35

13. NEW ELECTROMAGNETIC COMPATIBILITY38 14. TECHNICAL DATA

40

15. SYMBOLS

41

23

16. APPENDIX

44

6.2. DISCONNECTING THE HANDPIECE 

24

16.1. PROBE COMPATIBILITY TABLE

44

6.3. RECORDING TREATMENT DATA

25

16.2. FCC AND IC

44

6.4. DISCONNECTING THE STONE CATCHER  26 6.5. ELIMINATING THE STONE CATCHER CONTENTS26

4

6.6. CONSERVING THE STONE CATCHER CONTENTS26

1. WARNING Boston Scientific (distributor) and EMS accept no liability for direct or consequential injury or damage resulting from improper use, arising in particular through non-observance of the operating instructions, or improper preparation and maintenance.  Before using this product, please carefully read,

understand, and follow the recommendations in the instruction manual. Failure to observe the operating instructions may result in the patient or user suffering serious injury or the product being damaged. This product may only be applied for its intended use by qualified personnel and for the applications described in this manual. If the product is used in combination with other instruments, please refer to their instruction manual.

 Do not use this product in the presence of flammable

 or sterilization, the handpiece must have the lumen F positionned vertically in the sterilizer.  efore proceeding to the disconnection of the stone B catcher, proceed with the purge explained in the post treatment section.  or single use component: risk of contamination. F Do not use after the expiration date on the package label.  Do not use the product in surgery after any product

update without first performing functional tests.

anesthetics or oxidizing gases (such as nitrous oxide (N2O) and oxygen) or in close proximity to volatile solvents (such as ether or alcohol), as explosion may occur.

 If a probe breaks distally, use sterile grasping forceps

 Before using the product, inspect for any damage.

 Throughout the entire treatment, keep the probe

Do not use if the product is damaged. Use original EMS spare parts and accessories only.

 Do not modify or repair the product yourself. Please

contact your local Boston Scientific sales representatives.

 To avoid injury or damage, make sure that the

fragmentation energy is supplied only upon contact of the probe with the stone.

 Do not touch the probe during activation.

to remove probe pieces from the urinary tract. tips under endoscopic vision.

 T he probe tip should be extended 10 - 20 mm

beyond the endoscope tip.

 An excessively high suction level can impair the

endoscopic vision, collapse an organ, or damage the mucosa.

 Safe storage and transportation to the reprocessing

 When the mains power switch is in the “0” position,

area shall be applied to avoid any damage to the instrument and contamination to the environment and the people involved in the reprocessing process.

 Make sure that the handpiece, handpiece fluid

Check all wearing parts, regularly, for wear, and replace if necessary.

the product is disconnected from the supply network. aspiration connector, and re-usable wrenches are sterilized before proceeding with installation.

 To avoid the risk of electric shock, this product must

only be connected to a mains power supply with protective earth. No modification shall be made on this product. The mains power switch of the product must be accessible at any time.

 Fragments blocked in the lumen of the probe and the

handpiece may lead to loss of suction and heating of the probe. If blockage occurs, stop lithotripsy. Use the unclogging rod to remove fragments from the probe and from the handpiece lumen before continuing.

5

2. COMPONENTS The components provided for your device will vary, according to your configuration.

1

2

3

5

4

9 10

6

7

13 11

8

12

NON STERILE ZONE REF

DESIGNATION

1

Console (with peristaltic pump) or

1

2

Cart - optional

1

3

Fluid management system - optional

1

4

USB key

1

5

2.5 L Demineralized water

1

6

Stone catcher support

1

7

Cooling system filling kit

1

8

Power cord

1

9

Wired pedal

1

10

Draining tube

1

11

External video cord - optional

1

12

Cleaning brush

1

13

Cleaning rod

1

Figure 1

6

QTY

14

16

18

15

17 19

STERILE ZONE REF

DESIGNATION

QTY

STERILE STATE

14

Stone catcher - optional

1

Provided sterile

15

Multiuse torque wrench

1

To be sterilized before use

16

Probe

1

Provided sterile

17

Unclogging rod

2

To be sterilized before use

18

Aspiration plug

1

To be sterilized before use

19

Handpiece

1

To be sterilized before use

Figure 2

1

REF 1

2 3 4 5 6 7

2

3

4

DESIGNATION Mains power switch Power supply connector Bus bar Pedal cord connector USB connector USB connector HDMI connector

5

6

7

TO BE USED YES YES YES YES YES YES YES

8

REF 8 9 10 11 12 13

9

10

11

12

DESIGNATION RJ45 connector Outlet connector Air plug connector Sub-D Level indicator Filling inlet connector

13

TO BE USED NO YES YES NO YES YES

Figure 3 Sub-D and RJ-45 (After Sales only). 

7

3. INSTALLATION Please make sure that you have all the required parts and tools to complete the installation of your device prior to starting work Refer to the Packing List. Follow the instructions in the indicated order.

3.2. FILLING THE COOLING SYSTEM  o avoid interruptions during treatment, make sure T that the cooling liquid is above the minimum level before use. If needed, fill the cooling system as described below.

3.1. INSTALLING THE CONSOLE 1. Install the console on a flat, stable surface or use the cart (optional) designed for the console. 2. Remove the protective film from the console. 3. Install the stone catcher support. Figure 5

 o not tilt the console more than 10 degrees when D there is water in the cooling system.

Figure 6 Figure 4 1. To remove the air vent plug, push the grey ring and pull the air vent simultaneously.

Figure 7

8

2. Fill the filling bottle and close it.

Figure 8

 nly use demineralized water to fill the cooling O system.

5. Push the filling tube into the filling inlet connector until it engages.

Figure 11

6. Invert the filling bottle and squeeze it to fill the tank. In case of over-filling, please refer to Emptying the Cooling Liquid Circuit section.

3. Connect the filling tube to the filling bottle.

Figure 9

4. Make sure that the metal locking part is in the down position.

Figure 10

Figure 12

 ake sure that the level of water in the tank is M between the min. and max. indicators.

Figure 13

9

7. Push the metal locking part down to remove the filling tube.

3.3. CONNECTING THE CONSOLE TO THE EQUIPOTENTIAL CONDUCTOR When applicable and according to your in-house protocol, connect the equipotential conductor at the rear of the console with the bus bar. The equipotential conductor provides a connection between the unit and the potential equalization bus bar of the electrical installation when necessary.

Figure 14 Figure 16 8. Re-insert the air vent plug up to the stop.

The equipotential cable is not supplied with the console.

3.4. CONNECTING THE VIDEO CORD (OPTIONAL)

 nly connect products compliant with IEC 60950 O or equivalent. Figure 15

The console must be OFF before connecting the video cord. 1. Connect the video cord to the HDMI connector at the rear of the console and to a video monitor that supports “Picture-in-Picture.” 2. Follow the instructions provided for the video monitor to select the video input.

Figure 17

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3.5. INSTALLING THE PEDAL

3.6. INSTALLING THE STONE CATCHER

1. Connect the pedal cord to the corresponding connector at the rear of the console.

Case 1: Use of a sterile, single-use Stone Catcher (optional)

Pay attention to the pedal cord connector indexation.

1. Screw the sterile connector of the stone catcher into the handpiece.

Figure 18 2. Make sure that the pedal cord connector is in the correct position and screw the securing nut.

Figure 20 2. Tighten the Stone Catcher lid.

Figure 21 Figure 19

3. Insert the stone catcher into the stone catcher support.

The pedal can be placed in a protective bag (not supplied). 3. Make sure that the pedal is in an accessible location before starting treatment.

Figure 22

11

Case 2: Use of an in-house aspiration system.

4. Open the pump.

1. Screw the aspiration plug to the handpiece.

Figure 23 5. Place the stone catcher output tube into the pump.

Figure 26 2. Connect the in-house aspiration system on the aspiration plug. 3. Follow the instructions provided for the in-house aspiration system. Figure 24 6. Close the pump. 7. Connect the stone catcher output tube end with the conical connector (A) to the optional fluid management system or to your fluid disposal system.

A

Figure 25 8. Make sure that the output tube is not twisted or under tension when placed in the peristaltic pump device head.

12

3.7. INSTALLING THE SINGLE-USE FLUID MANAGEMENT SYSTEM SET (OPTIONAL) AND REPLACEMENT POUCH 1. Suspend the two fluid pouches, on the cart or on an IV pole, at a level that is lower than the console.

4. When the open pouch is filled, open the closed clamp (B) first. 5. Close the open clamp (C) (adjacent to the filled pouch). 6. The filled pouch can be exchanged for a new empty pouch, using the Luer-lock connection.

Figure 30

Figure 27 2. Connect the fluid management system input tube (A) to the stone catcher output tube connector.

3.8. CONNECTING THE STERILIZED HANDPIECE TO THE CONSOLE

 ake sure that the handpiece connector is dry beM fore connecting it to the console. 1. To remove the protective cap from the handpiece cord, hold the metal part of the handpiece cable connector and push up on the cap using your thumb and index finger.

Figure 28 3. Close clamp (B) of one pouch to fill the first pouch. Clamp (C) stays open. A

Figure 31

C B

Figure 29

13

2. Remove the protective cap from the console.

2. Use the wrench to firmly tighten the appropriate probe on the handpiece. Multiuse Torque wrench

Figure 32 3. Connect the handpiece to the console. Figure 34

3.10. CONNECTING THE POWER CORD  onnect only to a FI protected mains power supply C (FI = Residual current protection).  o prevent damage to the console, make sure that T its rated voltage meets the local line voltage. Figure 33 4. Pay attention to the orientation of the handpiece connector.

Connect the power cord to the power socket at the rear of the console.

The red dot must be on top for proper alignment. 5. Make sure that the handpiece cord does not touch the floor and is not compressed or squeezed in any way that might impede circulation of the cooling liquid. 6. The handpiece connection to the console is maintained by a mechanical lock. During use, the lock icon (orange handpiece activation icon) remains illuminated.  o not exceed the maximum number of usage D cycles for the handpiece as specified in the Technical Data section. 3.9. INSTALLING A PROBE ON THE HANDPIECE 1. Select the appropriate probe. Refer to the Probe Compatibility Table section. 

14

Figure 35

4. GETTING STARTED 4.1. STARTING THE DEVICE 1. Use the mains power switch located on the rear panel to switch on the console.

3. The console automatically performs a series of diagnostic tests. 4. The console displays a green check mark successfully completed diagnostic test.

for each

In case of error messages, refer to the troubleshooting information provided on the screen or to the Troubleshooting section. 5. The console is ready for use when all diagnostic tests have been successfully completed. The touch screen can be operated when wearing surgical gloves.

Figure 36  o not disconnect the handpiece while the lock D icon is switched on (in orange), since this may result in damage.

4.2. ADJUSTING THE PARAMETERS 1. To access the PARAMETERS screen from the STAND BY screen, press PARAMETERS .

Figure 37 When the handpiece is connected when starting the device, the lock icon will be orange and the purge will start.

Figure 39 2. Configure the parameters as needed.

2. Wait until the STAND BY screen appears.

Figure 38

Figure 40

15

Click this pictogram

Meaning

Action

Log file download

To download the log file and save it on a USB drive. Several screens will appear.

Choose a language

To select the display language. Refer to the Setting the Language section.

Brightness

Use the

and

buttons to adjust the display brightness.

Volume

Use the

and

buttons to adjust the volume.

Back

To confirm and return to the previous screen. Table 1

4.2.1.

Choosing the Language

1. To access the language selection menu, press: From the READY screen

ð

From the STAND BY screen

ð

ð

Table 2

16

2. Click the language you want to select.

2. Select Console to view the installed software version number, product serial number, and cumulated treatment statistics.

Figure 41 3. To confirm the selected language, click OK.

Figure 44

3. Select Handpiece to view the handpiece serial number and cumulated treatment statistics.

Figure 42 4.3. EQUIPMENT DATA 1. From the STAND BY screen, select the equipment pictogram to consult its equipment data.

Figure 45

4. Select Probe to view the probe reference number, batch number, probe dimensions, and cumulated treatment statistics.

Figure 43

Figure 46

17

5. TREATMENT  o not let the handpiece remain in contact with the D patient during treatment.  uring treatment, an auditory information pulse will D be emitted.

5. Press the pedal completely (STEP 2) to activate both suction and energies and make sure that the quality meter is in the green zone and the fluid is moving through the suction tube.

1

This section provides guidance for using the product. It does not provide detailed instructions for performing lithotripsy procedures.

2 5.1. FUNCTIONAL TESTS If a function or component is not working as  explained below, refer to the Troubleshooting section.

1. From the STAND BY screen, press the START button to access the READY screen. 2. Insert the probe into a sterile receptacle of physiological fluid. 3. Use the 2-mode foot pedal.

Figure 48 6. Remove foot from the pedal to stop the functional test.

4. Press the pedal halfway (STEP 1) to activate suction and make sure that suction is working properly (fluid moving through the suction tube).

1

Figure 49

Figure 47

18

5.2. PROBE INSERTION  o not start treatment without ensuring that a D back-up probe is available.  o avoid bending the probe, make sure that the T probe and the endoscope are aligned. 1. Introduce and position the probe inside the endoscope. 2. The probe shall be in contact with the stone.

3. All probe and handpiece usage information are automatically recorded in the console (number of uses, time of use, etc.). 4. According to the type of treatment, two pre-settings are available: •

Hard Stones Treatment,

•

Soft Stones Treatment.

5. You can also set each parameter manually.

3. Make sure that the operation is performed with continuous endoscopic vision.

Refer to the following sections:  - Custom Settings,

5.3. TREATMENT SETTINGS

- Hard Stones Treatment Settings,

1. The probe is automatically recognized by the handpiece to configure the console parameters for each probe type.

- Soft Stones Treatment Settings.

2. If a new probe is connected, the system automatically set the recommended treatment parameters of this probe.

5.3.1.

Custom Settings

1. From the STAND BY screen, press the START button.

Figure 51 Figure 50

19

2. If required, adjust any settings manually as described in the following table:

Suction

Ultrasound

Impact

PICTOGRAMS

MEANING

ACTION

ON/OFF button

Use the ON/OFF button to activate or deactivate the functionality in question.

Impact power

Use the and buttons to adjust the impact power in percent from 10% to 100% (in 10% increments).

Impact frequency

Use the and buttons to adjust the frequency of impact pulses from 1 Hz to 12 Hz (in 1 Hz increments).

Ultrasound power

Use the and buttons to adjust the ultrasound power from 10% to 100% (in 10% increments).

Suction flow rate

Use the and buttons to adjust the suction flow rate from 10% to 100% (in 10% increments). This control is only active for consoles with an integrated peristaltic pump device. To provide instant visual feedback about the efficiency of the treatment.

Treatment Efficiency Indicator • Green: the treatment is working optimally

• Orange: the treatment is working suboptimally Menu

To return to the STAND BY screen from the READY screen. Table 3

5.3.2.

Hard Stones Treatment Settings

5.3.3.

1. To use the hard stones pre-settings, press the HARD STONES TREATMENT button from the STAND BY screen.

Soft Stones Treatment Settings

1. To use the soft stones pre-settings, press the SOFT STONES TREATMENT button from the STAND BY screen.

Figure 52 2. The READY screen will appear and display the hard stone treatment pre-settings.

2. The READY screen will appear and display the soft stones treatment pre-settings.

3. If required, adjust any settings manually as described in the table above.

3. If required, adjust any settings manually as described in the table above.

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5.4. ADAPTING SUCTION FLOW RATE

5.5. STARTING TREATMENT

To adapt the suction flow rate:

1. Go to the READY screen to start the treatment.

1. Use the suction flow rate control as described in Table 3.

2. Press the pedal halfway (STEP 1) to activate the suction.

Do not use the roller clamp of the stone catcher to adapt the suction flow rate.

3. Press the pedal completely (STEP 2) to activate both suction and the energies. 4. Release STEP 2 to deactivate energies. 5. Release STEP 1 to deactivate suction. Refer to the Functional Tests section for pedal use. After 1 minute of inactivity, the system automatically executes a purge and stops cooling the circuit. It is reactivated when you push the pedal.

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