Swiss LithoClast Trilogy Instructions for Use Rev G Feb 2019 PDF download

INSTRUCTIONS FOR USE BRUKSANVISNING BRUGSANVISNING GEBRUIKSAANWIJZING

Caution! Federal (USA) law restricts this device to sale by or on the order of a physician

SWISS LITHOCLAST® TRILOGY ENGLISH ... 3 NORSK ... 47 DANSK ... 91 NEDERLANDS ... 135

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ENGLISH

Please Read this First!

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. For technical issues or complaints related to the use of this product please contact your local customer service representative. 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.

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

It is intended to be reprocessed by trained reprocessing personnel, biomedical services, or by an external reprocessing contractor.

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About this Manual

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.

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),

•

Breastfeeding women,

•

Under the age of 18.

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We wish you lots of success!

Intended User

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.

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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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.

CONTENTS 1. WARNING�� 5 2. COMPONENTS�� 6 3. INSTALLATION�� 8 3.1. INSTALLING THE CONSOLE �� 8 3.2. FILLING THE COOLING SYSTEM �� 8 3.3. CONNECTING THE CONSOLE TO THE EQUIPOTENTIAL CONDUCTOR�� 9 3.4. CONNECTING THE VIDEO CORD (OPTIONAL)�� 9 3.5. INSTALLING THE PEDAL �� 9 3.6. INSTALLING THE STONE CATCHER �� 10 3.7. INSTALLING THE SINGLE-USE FLUID MANAGEMENT SYSTEM SET (OPTIONAL) AND REPLACEMENT POUCH �� 11 3.8. CONNECTING THE STERILIZED HANDPIECE TO THE CONSOLE �� 12 3.9. INSTALLING A PROBE ON THE HANDPIECE �� 12 3.10. CONNECTING THE POWER CORD�� 13

4. GETTING STARTED�� 14 4.1. STARTING THE DEVICE �� 14 4.2. ADJUSTING THE PARAMETERS�� 14

6.7. DISPOSING OF SINGLE-USE COMPONENTS �� 24 6.8. SWITCHING OFF THE CONSOLE�� 24

7. CLEANING, DISINFECTING, AND STERILIZING�� 25 7.1. MULTIUSE COMPONENTS�� 25 7.2. CONSOLE, PEDAL, AND CART�� 27

8. PRODUCT MAINTENANCE�� 28 8.1. COOLING LIQUID CIRCUIT MAINTENANCE 28 8.2. REPLACING WATER FILTER�� 30 8.3. REPLACING FUSES �� 31

9. PRODUCT STORAGE AND SHIPPING�� 32 9.1. SHIPPING THE PRODUCT�� 32

10. PRODUCT DISPOSAL�� 33 11. TECHNICAL SUPPORT�� 33 12. TROUBLESHOOTING�� 34 12.1. MANUAL HANDPIECE UNLOCKING�� 34 12.2. WEAK SUCTION�� 34

4.3. EQUIPMENT DATA�� 16

12.3. PROBE NOT COMPATIBLE WITH THE ENDOSCOPE�� 34

5. TREATMENT�� 17

12.4. DISPLAYED ERROR MESSAGES �� 34

5.1. FUNCTIONAL TESTS�� 17

13. ELECTROMAGNETIC COMPATIBILITY�� 37

5.2. PROBE INSERTION�� 18 5.3. TREATMENT SETTINGS�� 18 5.4. ADAPTING SUCTION FLOW RATE�� 20

14. TECHNICAL DATA�� 41 15. SYMBOLS�� 42

5.5. STARTING TREATMENT�� 20

16. APPENDIX�� 45

6. POST-TREATMENT PROCEDURE�� 21

16.1. SINGLE USE PROBE COMPATIBILITY TABLE�� 45

6.1. COMPLETING TREATMENT�� 21 6.2. DISCONNECTING THE HANDPIECE �� 22 6.3. RECORDING TREATMENT DATA�� 23 6.4. DISCONNECTING THE STONE CATCHER �� 24 6.5. ELIMINATING THE STONE CATCHER CONTENTS�� 24

4

6.6. CONSERVING THE STONE CATCHER CONTENTS�� 24

16.2. FCC AND IC�� 45

Do not use this product in the presence of flammable

or sterilization, the handpiece must have the lumen F positioned 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 cleaned and sterilized according to the instructions in section 7.1 before proceeding with installation.

- Disinfection must be performed no later than 1 hour after the cleaning phase. - Sterilization must be performed after disinfection. 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.

The lowest effective settings should be used when

attempting to break a stone to reduce the possibility of: 1) damage to the kidney or ureteral wall; or 2) propelling a stone fragment into the surrounding tissue

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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.

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 handpiece cleaning rod or probe cleaning rod to remove fragments from the probe and from the handpiece lumen before continuing. Make sure that the handpiece connector is dry before connecting it to the console. The housing of the console is not waterproof.

Before shipping the product, follow the instructions provided in the Cleaning, Disinfecting and Sterilizing section.

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Before using this product, please carefully read,

ENGLISH

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.

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1. WARNING

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

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2

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8

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9 10

NON STERILE ZONE REF

DESIGNATION

1

Console (with peristaltic pump)

1

2

Cart - optional

1

3

Fluid management system (single use) - optional

1

4

2.5 L Demineralized water

1

5

Stone catcher holder

1

6

Filling bottle

1

7

Power cord

1

8

Wired pedal

1

9

Draining tube

1

10

External video cord - optional

1

Figure 1

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QTY

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11

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13

16

14

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STERILE ZONE REF

DESIGNATION

QTY

11

Stone catcher (single use) - optional

1

12

Probe (see single use probe compatibility

1

STERILE STATE Provided sterile

13

Probe cleaning rod

1

14

Multiuse torque wrench

1

15

Handpiece cleaning rod

2

16

Suction connector

1

17

Handpiece

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table at the end of this manual)

To be sterilized before use*

* Shall be reprocessed prior its first and subsequent uses according to the instructions in section 7.1 of this manual.

Figure 2

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REF DESIGNATION DESIGNATION REF 11

22 33 44 5 5 6 6 7

7

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NORMAL USE REF REFDESIGNATION DESIGNATION TO BE USED Mains power switch YES RJ45 connector Mains power switch YES 8 8 RJ45 connector Power supply connector 9 9 Outlet connector Power supply connector YES YES Outlet connector Bus bar 10 10 AirAir plug connector Equipotential connector YES YES plug connector Pedal cord connector 11 11 Sub-D Pedal cord connector YES YES Sub-D USB connector YES 12 indicator USB connector NO* 12 Level Level indicator USB connector YES 13 Filling inlet connector USB connector NO* 13 Filling inlet connector HDMI connector YES HDMI connector YES

TONORMAL BE USEDUSE NONO* YES YES YES YES NONO* YES YES YES

YES

Figure 3 * Sub-D, RJ-45 and USB: for After Sales only.

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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 holder. Do not place anything on the top cover of the console. The console must be placed in a properly ventilated place

Figure 5 Refer to the section 8.1.2 Filling the cooling circuit instructions on filling the cooling liquid circuit. for o not tilt the console more than 10 degrees when D there is water in the cooling system.

Figure 6

Figure 4

8

Pay attention to the pedal cord connector orientation.

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The equipotential connection provides a potential equilization connection between the unit and the electrical installation when necessary.

Figure 7 The equipotential cable is not supplied with the console.

Figure 9 2. Make sure that the pedal cord connector is in the correct position and screw the securing nut.

3.4. CONNECTING THE VIDEO CORD (OPTIONAL)

nly connect products compliant with IEC 60950 O or equivalent. 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 10 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. nsure the following components are sterilized E before use:

Figure 8

ENGLISH

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

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When applicable and according to your in-house protocol, connect the equipotential cable at the rear of the console with the equipotential connector.

3.5. INSTALLING THE PEDAL

•

Multiuse torque wrench

•

Handpiece cleaning rod

•

Suction connector

•

Handpiece

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3.3. CONNECTING THE CONSOLE TO THE EQUIPOTENTIAL CONDUCTOR

3.6. INSTALLING THE STONE CATCHER

4. Open the pump.

Case 1: Use of a sterile, single-use Stone Catcher (optional) 1. Screw the sterile connector of the stone catcher into the handpiece.

Figure 14 5. Place the stone catcher output tube into the pump.

Figure 11 2. Tighten the Stone Catcher lid.

Figure 15 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.

Figure 12 3. Insert the stone catcher into the stone catcher holder.

Figure 13

Figure 16 Be careful not to pinch the stone catcher output tube when closing the pump. 8. Make sure that the output tube is not twisted or under tension when placed in the peristaltic pump device head.

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1. Screw the suction connector to the handpiece.

ENGLISH

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

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

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1. Suspend the two fluid pouches, on the cart or on an IV pole, at a level that is lower than the console.

Figure 17

3. Follow the instructions provided for the in-house aspiration system.

Figure 18 2. Connect the fluid management system input tube (A) to the stone catcher output tube connector.

Figure 19 3. Close clamp (B) of one pouch to fill the first pouch. Clamp (C) stays open. A

C B

Figure 20

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2. Connect the in-house aspiration system on the suction connector.

4. When the open pouch is filled, open the closed clamp (B) first.

2. Remove the protective cap from the console.

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 23 3. Connect the handpiece to the console. Figure 21 3.8. CONNECTING THE STERILIZED HANDPIECE TO THE CONSOLE

ake sure that the handpiece connector is dry M before 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 pull on the cap using your second hand.

Figure 24 4. Pay attention to the orientation of the handpiece connector. 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.

Figure 22

o not exceed the recommended number of D usage 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 16.1 SINGLE USE PROBE COMPATIBILITY TABLE.

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ENGLISH

2. Use the wrench to firmly tighten the appropriate probe on the handpiece. One click from the torque wrench indicates the probe is firmly tightened.

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Multiuse Torque wrench

Figure 25

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

Figure 26

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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 27 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 28 When the handpiece is connected when starting the device, the lock icon will be orange and the purge will start.

Figure 30 2. Configure the parameters as needed.

2. Wait until the STAND BY screen appears.

Figure 29

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Figure 31

ENGLISH

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.

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Meaning

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Click this pictogram

Table 1 4.2.1.

Choosing the Language

From the READY screen

ð

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

ð

Table 2

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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 32 3. To confirm the selected language, click OK.

Figure 35

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

Figure 33 4.3. EQUIPMENT DATA 1. From the STAND BY screen, select the equipment pictogram to review its equipment data.

Figure 36

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

Figure 34

Figure 37

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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.

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o not let the handpiece remain in contact with the D patient during treatment.

1

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

ENGLISH

5. TREATMENT

2 5.1. FUNCTIONAL TESTS

2. Insert the probe into a sterile receptacle of irrigation fluid. 3. Use the 2-mode foot pedal.

Figure 39 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 40

Figure 38

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NEDERLANDS

1. From the STAND BY screen, press the START button to access the READY screen.

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

5.2. PROBE INSERTION o not start treatment without ensuring that a D back-up probe is available. ending of the probe may lead to a reduction in B ultrasound efficiency and/or probe’s breakage. To avoid bending the probe, make sure that the probe and the endoscope are aligned. 1. Introduce and position the probe inside the endoscope.

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.

2. The probe shall be in contact with the stone. Refer to the following sections: - Custom Settings,

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

- Hard Stones Treatment Settings, - Soft Stones Treatment Settings.

5.3. TREATMENT SETTINGS 1. The probe is automatically recognized by the handpiece to configure the console parameters for each probe type. 2. If a new probe is connected, the system automatically sets the recommended treatment parameters of this probe.

5.3.1.

Custom Settings

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

Figure 42

Figure 41

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MEANING

ACTION 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

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ON/OFF button

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Suction

Ultrasound

Impact

PICTOGRAMS

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.

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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.

ENGLISH

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

Soft Stones Treatment Settings

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

Figure 43 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.

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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. 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. Actively monitor the entire suction tubing to avoid sharp peaks, valleys or kinks that could lead to stone cloggings. If fluids stops flowing through tubing, massage tubing in area where clogging occurs to loosen the clogs.

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EMS Swiss

EMS Electro Medical Systems -Urology-Swiss LithoClast Lithotripsy Devices

Swiss LithoClast Trilogy Instructions for Use Rev G Feb 2019