Lithoclast Trilogy Model FT-231 and FT-232 Instructions For Use June 2017

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SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL

Please Read this First! Thank you for purchasing this new EMS product. It meets the highest quality and safety standards. 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 EMS authorized service center or your dealer directly. We wish you lots of success!

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.

EMS Contraindications and Patient Population 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. To prevent injury to people and damage to property, please follow the corresponding directives. They are marked as indicated:

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).

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

Caution: Risk of patient or user injury. Risk of damage to the product or environmental harm.

•

Perforation,

•

Hemorrhage,

Note: Useful additional information and hints.

•

Lesion,

•

Stone migration,

•

Pain/colic,

Intended Use

•

Macroscopic hematuria,

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

•

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. SAFETY PRECAUTIONS

5

2. COMPONENTS

6

3. INSTALLATION

8

3.1. INSTALLING THE CONSOLE 

8

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

6.7. DISPOSING OF SINGLE-USE COMPONENTS25 6.8. SWITCHING OFF THE CONSOLE

25

8

7. CLEANING, DISINFECTING, AND STERILIZING

26

10

7.1. MULTIUSE COMPONENTS

26

7.2. CONSOLE, PEDAL, AND CART

28

8. PRODUCT MAINTENANCE

29

3.4. CONNECTING THE VIDEO CORD (OPTIONAL)10 3.5. INSTALLING THE PEDAL 

11

3.6. INSTALLING THE STONE CATCHER 

11

3.7. INSTALLING THE SINGLE-USE FLUID MANAGEMENT SYSTEM SET (OPTIONAL) AND REPLACEMENT POUCH  13

8.1. COOLING LIQUID CIRCUIT MAINTENANCE 29 8.2. REPLACING FUSES 

30

8.3. DOWNLOADING LOGFILE

30

9. PRODUCT STORAGE AND SHIPPING

31

3.8. CONNECTING THE STERILIZED HANDPIECE TO THE CONSOLE 

13

9.1. EMPTYING THE COOLING LIQUID CIRCUIT 31

3.9. INSTALLING A PROBE ON THE HANDPIECE 

14

9.2. SHIPPING THE PRODUCT

32

3.10. CONNECTING THE POWER CORD

14

10. PRODUCT DISPOSAL

33

4. GETTING STARTED

15

11. EMS TECHNICAL SUPPORT

33

4.1. STARTING THE DEVICE 

15

12. TROUBLESHOOTING

34

4.2. ADJUSTING THE PARAMETERS

15

12.1. MANUAL HANDPIECE UNLOCKING

34

4.3. EQUIPMENT DATA

17

12.2. WEAK SUCTION

34

5. TREATMENT

18

5.1. FUNCTIONAL TESTS

18

5.2. PROBE INSERTION

19

5.3. TREATMENT SETTINGS

19

5.4. ADAPTING SUCTION FLOW RATE

21

5.5. STARTING TREATMENT

21

6. POST-TREATMENT PROCEDURE

22

6.1. COMPLETING TREATMENT

22

6.2. DISCONNECTING THE HANDPIECE 

23

6.3. RECORDING TREATMENT DATA

24

6.4. DISCONNECTING THE STONE CATCHER  25 6.5. ELIMINATING THE STONE CATCHER CONTENTS25

4

6.6. CONSERVING THE STONE CATCHER CONTENTS25

12.3. PROBE NOT COMPATIBLE WITH THE ENDOSCOPE34 12.4. DISPLAYED ERROR MESSAGES 

34

13. FORMER ELECTROMAGNETIC COMPATIBILITY37 14. NEW ELECTROMAGNETIC COMPATIBILITY40 15. TECHNICAL DATA

42

16. SYMBOLS

43

17. APPENDIX

46

17.1. PROBE COMPATIBILITY TABLE

46

17.2. FCC AND IC

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SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL

1. SAFETY PRECAUTIONS EMS and the distributor of this product 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. Instructions for use are explicitly given at installation by an EMS representative.  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

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.

 Before using the product, inspect for any damage.

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

 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.

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

the product is disconnected from the supply network.

 Do not tilt or flip the console without first having

purged the cooling system. Always empty the cooling circuit before transport. Please refer to Emptying the Cooling Liquid Circuit section.

 D o not start treatment without ensuring that a

back-up probe is available.

 Make sure that the handpiece, handpiece fluid

aspiration connector, and re-usable wrenches are sterilized before proceeding with installation.

 Any serious incident that has occurred in relation to

the product should be reported to the manufacturer and the competent authority.

contact an EMS authorized service center.

 To avoid risk of contamination, before each use,

always clean, disinfect and sterilize the product according to the EMS reprocessing instructions.

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

2

1

3

4

6

5

10 7

11

8

14 12

9

13

NON STERILE ZONE REF

DESIGNATION

QTY

1

Console (with peristaltic pump) or

1

2

Console (with pinch valve)

1

3

Cart - optional

1

4

Fluid management system - optional

1

5

USB key

1

6

2.5 L Demineralized water

1

7

Stone catcher support

1

8

Cooling system filling kit

1

9

Power cord

1

10

Wired pedal

1

11

Draining tube

1

12

External video cord - optional

1

13

Cleaning brush

1

14

Cleaning rod

1

Figure 1

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16

15

18

17

20 19 21

STERILE ZONE REF

DESIGNATION

QTY

STERILE STATE

15

Standard wrench

1

To be sterilized before use

16

Stone catcher - optional

1

Provided sterile

17

Multiuse torque wrench

1

To be sterilized before use

18

Probe

1

Provided sterile

19

Unclogging rod

2

To be sterilized before use

20

Aspiration plug

1

To be sterilized before use

21

Handpiece

1

To be sterilized before use

Figure 2

1

REF 1

2 3 4 5 6 7

2

3

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

4

5

6

TO BE USED YES YES YES YES YES YES YES

7

8

9

REF 8 9 10 11 12 13

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).



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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.

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.

Follow the instructions in the indicated order. 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

Do not tilt the console more than 10 degrees when 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

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SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL

2. Fill the filling bottle and close it.

Figure 8

 nly use demineralized water to fill the cooling O system. 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

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.

Figure 12

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

Figure 13

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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)

Only connect products compliant with IEC 60950 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 an in-house aspiration system.

Pay attention to the pedal cord connector indexation.

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

1. Screw the aspiration plug to the handpiece.

Figure 20 2. Connect the in-house aspiration system on the aspiration plug. 3. Follow the instructions provided for the in-house aspiration system.

Case 2: Use of a sterile, single-use Stone Catcher provided by EMS (optional) 1. Screw the sterile connector of the stone catcher into the handpiece.

Figure 19 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 21

11

2. Tighten the Stone Catcher lid.

3. Close the pump. 4. 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 22

A

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

Figure 26 5. Make sure that the output tube is not twisted or under tension when placed in the peristaltic pump device head. Figure 23 •

4. Proceed according to your device: •

For Pinch Valve Device

1. To insert the stone catcher output tube into the pinchvalve, push the pinch valve device and insert simultaneously the tube.

For Peristaltic Pump Device

1. Open the pump.

A

Figure 24 2. Place the stone catcher output tube into the pump.

Figure 27 2. Connect the stone catcher output tube end with the conical connector (A) to an external vacuum source.

Figure 25

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SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL

3.7. INSTALLING THE SINGLE-USE FLUID MANAGEMENT SYSTEM SET (OPTIONAL) AND REPLACEMENT POUCH For the peristaltic pump device only

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.

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

Figure 31

3.8. CONNECTING THE STERILIZED HANDPIECE TO THE CONSOLE Figure 28 2. Connect the fluid management system input tube (A) to the stone catcher output tube connector.

Make sure that the handpiece connector is dry 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 push up on the cap using your thumb and index finger.

Figure 29 3. Close clamp (B) of one pouch to fill the first pouch. Clamp (C) stays open. A

Figure 32 C B

Figure 30

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2. Remove the protective cap from the console.

2. Use the wrench to firmly tighten the appropriate probe on the handpiece. Case 1: Standard wrench

Figure 35

Figure 33 3. Connect the handpiece to the console.

Case 2: Multiuse Torque wrench

Figure 34 4. Pay attention to the orientation of the handpiece connector.

Figure 36

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.

3.10. CONNECTING THE POWER CORD  onnect only to a FI protected mains power supply C (FI = Residual current protection).

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 prevent damage to the console, make sure that T its rated voltage meets the local line voltage.

 o not exceed the maximum number of usage cyD cles for the handpiece as specified in the Technical Data section.

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

3.9. INSTALLING A PROBE ON THE HANDPIECE 1. Select the appropriate probe.  isk of contamination: do not use after the expiration R date on the package label. Refer to the Probe Compatibility Table section.  Figure 37

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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. 4.2. ADJUSTING THE PARAMETERS Figure 38  o not disconnect the handpiece while the lock D icon is switched on (in orange), since this may result in damage.

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

Figure 39 When the handpiece is connected when starting the device, the lock icon will be orange and the purge will start.

Figure 41 2. Configure the parameters as needed.

2. Wait until the STAND BY screen appears.

Figure 40

Figure 42

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

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SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL

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

Figure 46

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

Figure 44

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

Figure 47

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

Figure 45

Figure 48

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5. TREATMENT  o avoid the risk of electric shock, this product must T 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.

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

 o not use the product in surgery after any product D update without first performing functional tests.  ragments blocked in the lumen of the probe and F 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.

Figure 50 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. Figure 49

1

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

2

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

5.1. FUNCTIONAL TESTS

Figure 51

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

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

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 52

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SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL

5.2. PROBE INSERTION

•

For pinch valve device

Do not touch the probe during activation. If a probe breaks distally, use sterile grasping forceps to remove probe pieces from the urinary tract. 1. Throughout the entire treatment, keep the probe tips under endoscopic vision. To avoid bending the probe, make sure that the probe and the endoscope are aligned. The probe tip should be extended 10 - 20 mm beyond the endoscope tip. 2. Introduce and position the probe inside the endoscope. 3. The probe shall be in contact with the stone. 4. Make sure that the operation is performed with continuous endoscopic vision.

Figure 54 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:

5.3. TREATMENT SETTINGS

•

Hard Stones Treatment,

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

•

Soft Stones Treatment.

5. You can also set each parameter manually.

2. The READY screen will display factory settings or the settings used for the previous treatment. •

Refer to the following sections:  - Custom Settings,

For peristaltic pump device

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

5.3.1.

Custom Settings

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

Figure 53

Figure 55

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

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

Impact frequency

and buttons to adjust the frequency of impact Use the 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 works properly.

• Orange: the treatment is not efficient. 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 56 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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SWISS LITHOCLAST BLAST - FB-610/EN 23-JUNE-2017 / EMS CONFIDENTIAL