E M S Electro Medical Systems GRDLNBPVMEO Intracorporeal lithotripter User Manual 2 EN 2ANZC GRDLNBPVMEO

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INSTRUCTIONS FOR USE
Caution! Federal (USA) law restricts this device
to sale by or on the order of a physician
FT-235
2
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.
CONTENTS
1. WARNING
2. COMPONENTS
3. INSTALLATION
3.1. INSTALLING THE CONSOLE 
3.2. FILLING THE COOLING SYSTEM 
3.3. CONNECTING THE CONSOLE TO THE
EQUIPOTENTIAL CONDUCTOR
11
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
6.7. DISPOSING OF SINGLE-USE
COMPONENTS26
6.8. SWITCHING OFF THE CONSOLE
26
7. CLEANING, DISINFECTING,
AND STERILIZING
27
7.1. MULTIUSE COMPONENTS
27
7.2. CONSOLE, PEDAL, AND CART
29
8. PRODUCT MAINTENANCE
30
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
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
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
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.
When the mains power switch is in the “0” position,
the product is disconnected from the supply network.
 or sterilization, the handpiece must have the lumen
positionned vertically in the sterilizer.
 efore proceeding to the disconnection of the stone
catcher, proceed with the purge explained in the
post treatment section.
 or single use component: risk of contamination.
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.
Do
not touch the probe during activation.
If a probe breaks distally, use sterile grasping forceps
to remove probe pieces from the urinary tract.
Throughout
the entire treatment, keep the probe
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
area shall be applied to avoid any damage to the
instrument and contamination to the environment
and the people involved in the reprocessing process.
sure that the handpiece, handpiece fluid
aspiration connector, and re-usable wrenches are
sterilized before proceeding with installation.
	Check all wearing parts, regularly, for wear, and
replace if necessary.
To avoid the risk of electric shock, this product must
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.
Make
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
2. COMPONENTS
The components provided for your device will vary, according to your configuration.
10
13
11
12
NON STERILE ZONE
REF
DESIGNATION
Console (with peristaltic pump) or
Cart - optional
Fluid management system - optional
USB key
2.5 L Demineralized water
Stone catcher support
Cooling system filling kit
Power cord
Wired pedal
10
Draining tube
11
External video cord - optional
12
Cleaning brush
13
Cleaning rod
Figure 1
QTY
14
16
18
15
17
19
STERILE ZONE
REF
DESIGNATION
QTY
STERILE STATE
14
Stone catcher - optional
Provided sterile
15
Multiuse torque wrench
To be sterilized before use
16
Probe
Provided sterile
17
Unclogging rod
To be sterilized before use
18
Aspiration plug
To be sterilized before use
19
Handpiece
To be sterilized before use
Figure 2
REF
DESIGNATION
Mains power switch
Power supply connector
Bus bar
Pedal cord connector
USB connector
USB connector
HDMI connector
TO BE USED
YES
YES
YES
YES
YES
YES
YES
REF
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).
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
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
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
2. Fill the filling bottle and close it.
Figure 8
 nly use demineralized water to fill the cooling
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
between the min. and max. indicators.
Figure 13
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
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
10
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.
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.
Figure 31
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
(FI = Residual current protection).
 o prevent damage to the console, make sure that
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
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
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
patient during treatment.
 uring treatment, an auditory information pulse will
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.
This section provides guidance for using the product.
It does not provide detailed instructions for performing
lithotripsy procedures.
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).
Figure 49
Figure 47
18
5.2. PROBE INSERTION
 o not start treatment without ensuring that a
back-up probe is available.
 o avoid bending the probe, make sure that the
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,
- Soft Stones 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 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.
20
5.4. ADAPTING SUCTION FLOW RATE
To adapt the suction flow rate:
5.5. STARTING TREATMENT
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.
21
6. POST-TREATMENT PROCEDURE
6.1. COMPLETING TREATMENT
1. Remove the probe from the endoscope.
Figure 53
Do not disconnect the probe and the handpiece
at this stage.
2. Switch off IMPACT and ULTRASOUND from the
READY screen before starting this procedure.
3. Tilt the stone catcher.
Figure 55
To accelerate the emptying procedure, the stone
catcher can be disconnected from the handpiece.
5. The suction tubes must be cleared.
6. Loosen the probe from the handpiece, using one of
the following methods.
Figure 54
4. Press the pedal halfway (STEP 1) for a few seconds
to empty the suction circuit and reduce the level of
water in the stone catcher.
Figure 56
22
Figure 57
Figure 59
1. Pull back the metallic part of the handpiece connector
to disconnect the handpiece.
Figure 60
Figure 58
 ait until the lock icon switches off. The handpiece
cannot be disconnected when the lock icon is on.
If the mechanical disconnection of the handpiece
is not possible when the console is switched off,
refer to the Troubleshooting section.
2. Plug the cap on the handpiece connector in the front
panel.
6.2. DISCONNECTING THE HANDPIECE
 ake sure that the console is still on during this
procedure.
Make sure that the lock icon is off.
Figure 61
23
6.3. RECORDING TREATMENT DATA
1. Select History
to view the statistics for the last 5 treatment sessions.
From the READY screen:
From the STAND BY screen:
ð
Table 4
2. Information on the previous treatment sessions will be displayed.
Figure 62
3. Press NEXT PAGE to display more previous treatment data.
Figure 63
24
6.4. DISCONNECTING THE STONE CATCHER
1. Disconnect the stone catcher from the handpiece
and from the fluid management system or from your
vacuum system.
6.8. SWITCHING OFF THE CONSOLE
 ake sure that the lock icon is switched off
before turning off the console.
•
Set the mains power switch to 0.
Figure 64
Figure 66
6.5. ELIMINATING THE STONE CATCHER
CONTENTS
If the stone fragments are not to be kept for analysis,
dispose of them. Refer to the Product Disposal section.
6.6. CONSERVING THE STONE CATCHER
CONTENTS
If the stone fragments are to be kept for analysis, close
the receptacle with the yellow transport closing cap,
supplied with the stone catcher.
Figure 65
6.7. DISPOSING OF SINGLE-USE COMPONENTS
Dispose of single-use components (probe, Stone Catcher
and fluid management system) in accordance with
hospital protocol.
25
7. CLEANING, DISINFECTING, AND STERILIZING
7.1. MULTIUSE COMPONENTS
Step A: Preparation at the Point of Use
 fter contamination, the sample is allowed to dry
for 1 hour at room temperature.
Step B: Pre-cleaning
For the handpiece, place the protective cap onto
the handpiece connector before cleaning.
 o not remove the protective cap until reprocesD
sing is completed.
Cleaning
EMS recommends using Neodisher® MediClean as the
cleaning agent as it has been used for the validation
study.
•
Wipe the product with a damp cloth to remove
gross contamination.
•
Rinse the product under running tap water for
20 seconds
•
Immerse the product in 0.5% cleaning solution
for 10 minutes. Make sure that all surfaces are
moistened.
•
EMS recommends using Neodisher® MediClean
at 30°C.
•
Rinse the product with a water jet pistol for
20 seconds, while paying special attention to each
gap, slit, or hidden surface.
•
Rinse the product under cold tap water.
•
Dry the product by blowing air for 20 seconds.
Disinfection
The following test devices, materials & machines have
been used for the validation study:
Figure 67
1. Wipe the product with a damp cloth.
2. Brush all accessible surface with a soft Bristol nylon
brush until all visible residues are removed;
•
Disinfection agent: Cidex® OPA.
•
Immerge the product in a disinfectant solution for
10 minutes. Care that all surfaces are moistened.
•
EMS recommended to use Cidex OPA at 20°C.
•
Rinse the product with a water jet pistol for
60 seconds, while paying special attention to each
gap, slit, or hidden surface.
•
Rinse the product under cold tap water.
3. Immerse the product in cold tap water for 5 minutes.
4. Use a syringe with 50mL of deionized water to flush
the lumen three times
5. Rinse the product with a water jet pistol (with a
minimum pressure of 3.8 bar) for 30 seconds.
Step C: Cleaning, disinfection and drying process
Step C1. Manual Cleaning, disinfection and drying
process
 isinfection must be performed no later than 1 hour
after the cleaning phase.
Sterilization must be performed after disinfection.
Drying
Dry the outside of the instrument with a lint-free towel.
Dry the lumen of the products with filtered compressed
air (max. pressure 3 bar).
The instrument must never be heated >138°C.
26
Step C2. Automated Cleaning, disinfection and drying
process
Automated Cleaning, disinfection and drying validation
has been performed using a Miele 7735CD washing
machine, and the cleaning agent Neodisher® Mediclean.
EMS recommends using Neodisher® Mediclean for their
products.
For this step, a Washer/Disinfector machine must have
suitable baskets to hold small, fragile products and rinsing
connections for the attachment to product lumina.
The program of the Washer/Disinfector machine shall be
able to perform the following steps.
Step E. Packaging for sterilization
Prior to sterilization, the products must be placed in a
suitable sterilization container or sterilization packaging:
Compliant with EN ISO 11607 or EN 868.
Step F. Sterilization
Sterilization of instruments by applying a fractionated
pre-vacuum process (according ISO 13060 and
ISO 17665) taking into consideration the respective
country requirements.
 o not exceed the maximum number of sterilization
cycles, please refer to the instruction manual.
Place the instrument in a suitable rack and start the
program. The Vario TD programs have been shown to
be effective:
F or
sterilization, the handpiece must have the
lumen positionned vertically in the sterilizer.
•
2 min pre-washing with cold water (<40°C). Drain;
•
5 min washing with 0.5% detergent at 55°C. Drain;
Step F1. Prevacuum sterilization
•
3 min neutralising with warm water (>40°C). Drain;
Parameters for the pre-vacuum cycle:
•
2 min intermediate rinsing with warm water
(>40°C). Drain.
•
3 prevacuum phases
•
Sterilization temperature of 132°C for 3 minutes
Special instructions of the manufacturer for the Washer/
Disinfector must be followed.
•
Drying time: minimum 20 min
•
Do not exceed a sterilization temperature of 138°C
and a holding time of 20 min.
Disinfection (if required by national laws)
Automated Thermal Disinfection in a Washer/Disinfector
taking into consideration national requirements in regards
to A0-Value (see EN 15883) e.g. 93°C for 3 minutes.
Step K. Storage
Storage of sterilized instruments in a dry, clean and dust
free environment at modest temperatures of 5°C to 40°C.
A machine cleaning and disinfection method should
always be used for cleaning/disinfection because of the
increased effectiveness of this method.
Sterilization must be performed after disinfection.
Drying
Drying of outside of instrument through drying cycle of the
Washer/Disinfector. If needed, additional manual drying
can be performed using a lint-free towel and filtered
compressed air (max. pressure 3 bar).
The instrument must never be heated >138°C.
Step D. Functional Testing, Maintenance
If stains are still visible on the product after cleaning/
disinfection, the entire cleaning/disinfection procedure
must be repeated. Products with visible damage, chips/
flakes, corrosion or bent out of shape must be disposed
of (no further use is permissible).
27
7.2. CONSOLE, PEDAL, AND CART
1. Turn off the console.
5. Use a cleaning wipe with proven efficacy (e.g., enzol
2%) to clean the surfaces.
The housing of the console is not waterproof.
6. To disinfect use 70% isopropyl alcohol or other
EPA-recognized surface disinfectant. Be sure to
carefully follow the instructions provided by the disinfection solution manufacturer.
Figure 68
2. Disconnect the power supply connector before
cleaning.
Figure 69
3. Remove the protective bag from the pedal, if applicable.
4. Plug the cap on the handpiece connector in the front
panel
Figure 70
28
8. PRODUCT MAINTENANCE
Should legal provisions in your country specify maintenance intervals, these must be observed. The console
and handpiece may need to be returned for periodic
servicing.
5. Replace the water filter.
For the spare parts described below, please refer to
the order form or contact local Boston Scientific sales
representative.
8.1. COOLING LIQUID CIRCUIT MAINTENANCE
 he cooling liquid and the water filter must be
replaced every year. Regular maintenance is
required for product to function properly.
1. Empty the cooling liquid circuit.
Refer to the Product Storage and Shipping section
 instructions on emptying the cooling liquid
for
circuit.
2. Place the console flat on its side.
Figure 72
 onnect the tubes to the corresponding color.
The grey ring is on the left and the green ring is
on the right.
6. Re-install the water filter (B) and cover (A).
Figure 71
3. Use the Torx tool size 20 to remove the water filter
cover (A).
4. Push the colored ring with your left hand and simultaneously pull the plug to remove the filter tube.
Figure 73
29
7. Replace the console on a flat surface.
8. Refill the cooling system. Refer to the Filling the
Cooling System section.
8.2. REPLACING FUSES
1. Disconnect the power cord at the rear of the console.
8.3. DOWNLOADING LOGFILE
Your local Boston Scientific sales representatives may
request this procedure.
1. Plug the USB key provided by EMS at the rear of the
console.
2. From the STANDBY screen, select PARAMETERS
3. Press LOGFILE DOWNLOAD.
4. Follow the procedure displayed on the screen.
Figure 74
2. Remove the fuse drawer located in the power socket.
Figure 75
3. Replace defective fuses with the fuse type specified
on the identification plate at the rear of the console.
4. Re-insert the fuse drawer.
5. If the fuses fail again, please contact your local Boston
Scientific sales representatives.
30
9. PRODUCT STORAGE AND SHIPPING
 o not tilt or invert the console without first having
emptied the cooling liquid circuit.
5. Put the draining tube in a receptacle that is more than
600 ml in volume.
 lways empty the cooling liquid circuit before
longterm storage (2 weeks or more) or shipping to
avoid damage to the console.
Storage and transport conditions are specified in
 Technical Data section.
the
9.1. EMPTYING THE COOLING LIQUID CIRCUIT
1. Unplug all cables at the rear of the console.
2. Place the console on a flat, stable surface.
3. To remove the air vent plug, push the grey ring with
your left hand and simultaneously pull the plug.
Figure 78
6. Connect the draining tube (supplied with the product)
to the outlet.
Figure 79
Figure 76
4. Make sure that the metal locking device is in the
down position.
7. Tilt the console until the connector is in contact with
the flat, stable surface to fully empty the cooling liquid
circuit.
Figure 77
Figure 80
31
8. Unlock the metal locking part to disconnect the
draining tube.
9.2. SHIPPING THE PRODUCT
 efore shipping the product, follow the instructions
provided in the Cleaning, Disinfecting and Sterilizing section.
 o avoid damage, pack the product and all accesT
sories in the original packaging. Make sure to insert
the air vent plug prior to packing and shipping the
product.
Figure 81
9. Re-insert the air vent plug.
32
10. PRODUCT DISPOSAL
The product must not be discarded in
domestic household waste.
Should you wish to definitively dispose
of the product, please comply with the
applicable regulations in your country.
Waste Electrical and Electronic Equipment belonging
to customers located in the European Union may be
shipped to EMS for recycling in accordance with the
WEEE regulations. The costs of recycling, exclusive of
shipping fees, are covered by EMS.
Keep the original packaging until the product is to be
disposed of permanently.
11. TECHNICAL SUPPORT
Please contact your local Boston Scientific sales representative for any product servicing or repairs.
Boston Scientific and EMS declines responsibility for the
safety of the product and declares the warranty null and
void if service or repair is carried out by an unauthorized
third party or if non-genuine spare parts are used.
It is mandatory to return your product in its original
packaging. By following these packaging guidelines,
your product shall be protected against damage during
shipment. To protect the personnel of the authorized
service center and for safety reasons during transport and
shipment, all products and accessories returned to the
factory for repair or servicing must be cleaned, disinfected
and sterilized in accordance with the instruction manual.
Repair can be refused for products or accessories
received
in a contaminated condition.
33
12. TROUBLESHOOTING
Ensure that the product and the accessories have
been used in accordance with the conditions
specified by specified in the instructions for use.
To improve our quality of service, please provide the
following information:
•
Product reference number,
•
Software revision,
•
Batch number/serial number,
•
Service history of the product (e.g., previous issues
or repairs).
12.2. WEAK SUCTION
1. Make sure that the stone catcher tube is correctly
inserted in the peristaltic pump.
2. Make sure that the stone catcher roller clamp is not
closed.
3. Check that no clogging occurs in the handpiece or
probe.
12.1. MANUAL HANDPIECE UNLOCKING
4. Make sure that there are no leaks in the suction circuit.
5. Replace the liquid collection pouch if it is full.
6. Make sure that the stone catcher cover is fully
tightened up to the stop.
7. Make sure that the stone catcher is correctly tightened
on the handpiece.
 nly use the manual handpiece unlocking
procedure when disconnection has failed.
Refer to the Disconnecting the Handpiece section.
1. Turn off the console.
2. Keep the console in its flat position.
3. Insert a needle (2mm diameter) until you reach the
stop.
4. Push the needle to the right to unlock the handpiece.
The handpiece is unlocked.
8. Increase the suction from the READY screen.
9. Open the cover of the pump to check that the rollers
on the head of the pump turn.
10.Make sure that there are no leaks in the collection
system.
12.3. PROBE NOT COMPATIBLE WITH THE
ENDOSCOPE
1. Refer to the Probe Compatibility Table section to
check the diameter and/or length of the probes with
respect to the dimensions of the endoscope.
2. Check the physical integrity of the probe.
3. Replace the probe.
12.4. DISPLAYED ERROR MESSAGES
Figure 82
5. Remove the handpiece.
In case of a malfunction or an operating error, the
faulty component is automatically highlighted in
the STAND BY screen.
In case of critical error, the system stops and
automatically reverts to the STAND BY screen.
34
Figure 83
1. Press the highlighted faulty component and follow
the interactive menu to identify the exact origin of
the error.
2. Follow the recommended action that is displayed.
•
3. If the solutions proposed fail to solve the problem,
please contact your local Boston Scientific sales representatives. Do not, in any case, return a product before
troubleshooting of the error has been performed.
4. The following table provides more detailed information
about failures: error number and associated error
messages.
Console
E001 - The cooling pump is not detected and handpiece cooling might not be available. Please restart device.
Please contact your service center if the error persists.
E002 - The cooling valve is not detected and handpiece cooling might not be available. Please restart device.
Please contact your service center if the error persists.
E008 - Configuration files of the console are corrupted and informations might be incorrect. Please contact your
service center.
E009 - Console internal communication error. Please restart device. Please contact your service center if the
error persists.
E010 - Pedal not detected. Please verify that the connector of the pedal is connected to the console. Please
contact your service center if the error persists.
E016 - No suction system has been detected. Please restart device or contact your service center if the error
persists.
E017 - Two suction systems seem to be connected. Please restart device or contact your service center if the
problem persists.
E018 - The console temperature is high. Treatment is still possible but verify the console is placed in a correctly
ventilated place
E019 - The console temperature is too high. System needs to cool down. Please keep it powered while temperature
returns to safe level.
E020 - Console internal communication error. System trying to recover. Please restart device or contact your
service center if the error persists.
E024 - Console internal communication error. Please restart device or contact your service center if the error persists.
35
E025 - Console temperature error. Please wait for the console to cool down. Please contact your service center
if the error persists.
E026 - Shockwave module critical error. Please restart the device. Please contact your service center if the error
persists.
E027 - Ultrasound module critical error. Please restart the device. Please contact your service center if the error
persists.
E031 - The console temperature sensor was not detected. Please restart the device. Please contact your service
center if the error persists.
E032 - Fan was not detected. Please restart the device. Please contact your service center if the error persists.
E034 - Handpiece lock not detected. Please restart the device. Please contact your service center if the error
persists.
E038 - The console temperature sensor was not detected. Please restart the device. Please contact your service
center if the error persists.
Table 5
•
Handpiece
E003 - The handpiece temperature is rising and could be harmful. Please let the system cool down. Verify cooling
tank water level and handpiece cord sealing. Please check that after handpiece disconnection that the handpiece
cooling circuit is dry. Please contact your service center if the error persists.
E004 - The handpiece temperature is high. Treatment is still possible but verify cooling tank level.
E005 - Handpiece not detected. Please verify that the handpiece is connected to the console. Replace the
handpiece if the error persists.
E037 - The handpiece temperature sensor was not detected. Please restart the device. Please contact your
service center if the error persists.
Table 6
•
Probe
E012 - Probe not detected. Please check that the probe is correctly installed on the handpiece. Please contact
your service center if the error persists.
E013 - Unknown probe. Please verify that the probe is a valid one or undamaged. Please contact your service
center if the error persists.
E035 - Probe settings can’t be automatically loaded. Please change probe. Please contact your service center if
the error persists.
Table 7
36
13.ELECTROMAGNETIC COMPATIBILITY
The SWISS LITHOCLAST® TRILOGY should not be used adjacent to or stacked with another SWISS
LITHOCLAST® TRILOGY. If adjacent or stacked use is necessary, the SWISS LITHOCLAST® TRILOGY should be
observed to verify normal operation in the configuration in which it will be used.
Portable and mobile RF communications equipment should be used no closer than 30 cm to any part of the
SWISS LITHOCLAST® TRILOGY, including cables.
Instructions for maintaining BASIC Safety and Essential performance for the expected Service life
The presence of transmitters near the SWISS LITHOCLAST® TRILOGY could affect its performances. The distances
mentioned in the tables prepared by manufacturer could help to prevent any disturbances of the equipment in normal
operation
The climatic environmental conditions could affect the life of critical components of the SWISS LITHOCLAST®
TRILOGY
Guidance and manufacturer’s declaration – electromagnetic emissions
The SWISS LITHOCLAST® TRILOGY is intended for use in the electromagnetic environment specified below. The
customer or the user of the SWISS LITHOCLAST® TRILOGY should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF emissions
Group 1
The SWISS LITHOCLAST® TRILOGY uses RF energy only for its
internal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
Class A
The emissions characteristics of the Swiss Lithoclast® Trilogy make it
suitable for use in industrial areas and. If it is used in a residential
environment (for which CISPR 11 class B is normally required) this
equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation
measures, such as relocating or re-orienting the equipment
CISPR 11
RF emissions
CISPR 11
Harmonics emissions
Class A
IEC 61000-3-2
Voltage fluctuations /
flicker emissions IEC
61000-3-3
Complies
Table 8
37
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The SWISS LITHOCLAST® TRILOGY is intended for use in the electromagnetic environment specified below. The
customer or the user of the SWISS LITHOCLAST® TRILOGY should ensure that it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient / burst
IEC
61000-4-4
Surge
IEC 61000-4-5
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
IEC 60601
test level
Compliance level
± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
± 2, ± 4, ± 6, ± 8 kV contact
± 2, ± 4, ± 8, ± 15 kV air
± 2 kV, 100 KHz for power
supply lines
±1 kV, 100 KHz for
input/output lines
± 2 kV, 100 KHz for power
supply lines
±1 kV, 100 KHz for
input/output lines
± 0.5, ± 1 kV line(s) to line(s)
±0.5, ±1, ± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
30 A/m
30 A/m
<5 % UT (>95 % dip in UT) for
0,5 cycle
40 % UT (60 % dip in UT) for 5
cycles
70 % UT (30 % dip in UT) for
25 cycles
0 % UT for 0,5 cycle at 0°, 45°,
90°, 135°, 180°, 225°, 270°
and 315°
0 % UT for 1 cycle single
phase
<5 % UT (>95 % dip in UT) for
5s
0% UT for 250 cycles
<5 % UT (>95 % dip in UT) for
0,5 cycle
40 % UT (60 % dip in UT) for 5
cycles
70 % UT (30 % dip in UT) for
25 cycles
0 % UT for 0,5 cycle at 0°, 45°,
90°, 135°, 180°, 225°, 270°
and 315°
0 % UT for 1 cycle single
phase
<5 % UT (>95 % dip in UT) for
5s
0% UT for 250 cycles
Table 14
38
Electromagnetic
environment - guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic
material,
the
relative humidity should be
at least 30%.
Mains power quality should
be that of a typical
commercial
or
hospital
environment.
Mains power quality should
be that of a typical
commercial
or
hospital
environment.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location
in
typical
commercial
or
hospital
environment.
Mains power quality should
be that of a typical
commercial
or
hospital
environment. If the user of
the SWISS LITHOCLAST®
TRILOGY
requires
continued operation during
power mains interruptions, it
is recommended that the
SWISS
LITHOCLAST®
TRILOGY be powered from
an uninterruptible power
supply or a battery.
UT is the a.c. mains voltage
(100-240) prior to application
of the test level.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The SWISS LITHOCLAST® TRILOGY is intended for use in the electromagnetic environment specified below. The
customer or the user of the SWISS LITHOCLAST® TRILOGY should ensure that it is used in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part of the SWISS LITHOCLAST®
TRILOGY, including cables, than the recommended separation distance calculated from the equation applicable to the
frequency of the transmitter.
These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radios, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered.
Immunity Test
IEC 60601
Test Level
Compliance level
Electromagnetic Environment
– Guidance
3 V rms
150 kHz to 80 MHz
6 V rms
in ISM and amateur radio bands
If the measured field strength
in the location in which the
SWISS
LITHOCLAST®
TRILOGY is used exceeds
the applicable RF compliance
level above, the SWISS
LITHOCLAST®
TRILOGY
should be observed to verify
normal operation. If abnormal
performance is observed,
additional measures may be
necessary, such as reorienting or relocating the
SWISS
LITHOCLAST®
TRILOGY.
Conducted RF
IEC 61000-4-6
3 V rms
150 kHz to 80 MHz
6 V rms
in ISM and amateur radio bands
Radiated RF
IEC 61000-4-3
Minimum separation distance
shall be calculated by
following equation:
3 V/m
80 MHz to 2.7 GHz
80% AM at 1KHz
39
3 V/m
80 MHz to 2.7 GHz
80% AM at 1KHz
E is the immunity test level in
[V/m]
d is the minimum separation
in [m]
P is the maximum power in
[W]
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
27 V/m
380-390 MHz
50% PM 18 Hz
27 V/m
380-390 MHz
50% PM 18 Hz
28 V/m
28 V/m
430-470 MHz
430-470 MHz
FM ±5 kHz deviation, 1kHz sine FM ±5 kHz deviation, 1kHz sine
9 V/m
704-787 MHz
50% PM 217 Hz
9 V/m
704-787 MHz
50% PM 217 Hz
28 V/m
800-960 MHz
50% PM 18 Hz
28 V/m
800-960 MHz
50% PM 18 Hz
28 V/m
1700-1990 MHz
50% PM 217 Hz
28 V/m
1700-1990 MHz
50% PM 217 Hz
28 V/m
2400-2570 MHz
50% PM 217 Hz
28 V/m
2400-2570 MHz
50% PM 217 Hz
9 V/m
5100-5800 MHz
50% PM 217 Hz
9 V/m
5100-5800 MHz
50% PM 217 Hz
RF
wireless
equipment
maximum output power and
separation distance tested (at
30 cm):
TETRA 400: max 1.8 W
GMRS 460, FRS 460: max 2
LTE Band 13, 17: max 0.2 W
GSM 800/900: max 2 W
TETRA 800: max 2W
iDEN 820: max 2W
CDMA 850: max 2 W
LTE Band 5: max 2W
GSM 1800/1900: max 2 W
CDMA 1900: max 2W
DECT: max 2 W
LTE Band 1,3,4,25: max 2 W
UMTS: max 2W
Bluetooth: max 2W
WLAN 802.11b/g/n: max 2W
RFID 2450: max 2W
LTE Band 7: max 2 W
WLAN 802.11 a/n: max 0.2 W
Interference may occur in the
vicinity of equipment marked
with the following symbol:
If the measured field strength in the location in which the SWISS LITHOCLAST® TRILOGY is used exceeds the
applicable RF compliance level above, the SWISS LITHOCLAST® TRILOGY should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the SWISS LITHOCLAST® TRILOGY
Table 9
Recommended separation distances between portable and mobile RF communications
equipment and the SWISS LITHOCLAST® TRILOGY
The SWISS LITHOCLAST® TRILOGY is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SWISS LITHOCLAST® TRILOGY can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the SWISS LITHOCLAST® TRILOGY as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter [m]
Rated maximum output 150 kHz to 80 MHz outside 150 kHz to 80 MHz in ISM 80 MHz to 2700 MHz (for
power of transmitter
ISM and amateur bands
and amateur bands
define RF Wireless transmitter
[W]
see table before)
d = 1.0
d = 1.0
d = 1.0
0.01
0.1 m
0.1 m
0.1 m
0.1
0.32 m
0.32 m
0.32 m
40
1
1m
1m
1m
10
3.2 m
3.2 m
3.2 m
100
10 m
10 m
10 m
Table 11
For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where power (P) is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply to all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Compliant cables and accessories
The use of accessories and cables other than those specified or sold by EMS as replacement parts may
result in increased emissions or decreased immunity of this product.
Cables and
accessories
Maximum
Complies with
length
Handpiece cord
< 2.9 m
Pedal
< 2.9 m
HDMI
> 2.9 m
Sector cord
> 2.9 m
CISPR 11 Class A / Group 1: RF electromagnetic disturbance
IEC 61000-4-2 Electrostatic discharge (ESD)
IEC 61000-4-3 Electromagnetic fields radiated by radio-frequencies
IEC 61000-4-4 Electric fast transient / burst
IEC 61000-4-5 Surge
IEC 61000-4-6 Disturbances induced by radio-frequency fields
IEC 61000-4-8 Power frequency magnetic field (50/60 Hz)
IEC 61000-4-11 Voltage dips, short interruptions and voltage variations
Table 12
Essential performance
The SWISS LITHOCLAST® TRILOGY has neither life sustaining functions nor diagnostic of life supporting functions.
41
14. TECHNICAL DATA
MANUFACTURER
E.M.S. Electro Medical Systems S.A., CH-1260 Nyon, Switzerland
MODEL
Swiss LithoClast® Trilogy
POWER SUPPLY
100 – 240 VAC, 50 – 60 Hz, 500 VA
OUTPUT POWER (ULTRASOUND)
70 Watt
OUTPUT POWER (SHOCK)
80 Watt
EN 60601-1 CLASSIFICATION
System: EN 60601-1: Class I
Probe: EN 60601-1: Class I BF
MDD 93/42 EEC CLASSIFICATION
Class IIb: device, handpiece
Class IIa: probes
Class I: fluid management system, pedal, torque wrench, cart
Class Is: Stone catcher
IEC 60529 IP CLASSIFICATION
Console (IP21)
Handpiece (IPX8)
Pedal (IPX8)
PRIMARY FUSE
6.3A, T (slow), 250 VAC (=T6.3A250V)
Dimensions: Ø5 X 20 mm
CONSOLE
Weight: 13.5 kg
Dimensions: height – 135 mm, width – 360 mm, depth – 420 mm
OPERATING CONDITIONS
Temperature: +10°C to +30°C
Relative humidity: 30% to 75%
Atmospheric pressure: 700 hPa to 1060 hPa
Max. altitude: 3000 m
TRANSPORT AND STORAGE
CONDITIONS
Probes, Stone catcher, Fluid Management system
Temperature: -29°C to +38°C
Relative humidity: 10% to 90%
Handpiece
Temperature: -29°C to +38°C
Relative humidity: max 85%
Console and its accessories
Temperature: +5°C to +38°C
Relative humidity: max 85%
PRODUCT USAGE PERIOD
Console lifetime: 7 years
Sterile accessories shelf-life: 2 years
Handpiece lifetime: 2 years or 100 usage cycles
Torque wrench lifetime: 3 years, or 6000 clicks/300 sterilizations
COOLING LIQUID
Demineralised water
MAXIMUM TRANSPORTABLE
WEIGTH ON THE CART
40kg
42
15. SYMBOLS
Distributor logo
Manufacturer logo
Product name
Origin of the product
Prescription device
Global Trade Item Number
Non Sterile
CE marking
CSA marking with “C” identification for products in conformance with Canadian
standards and “US” for products in conformance with US standards
Batch Number
DEKRA INMETRO identification for products in conformance with Brazilian electrical
standards
GOST R marking for products in conformance with Russian standards
Lock icon
Applied part, type BF
43
Manufacturer
Date of manufacture
Catalogue number
Disposal of Old Electrical & Electronic Equipment (Applicable in the European Union
and other European countries with separate collection systems)
Equipotential plug
Serial number
Refer to the instruction manual
Device requiring protective earth
Input
Fuse
Risk of electric shock
Emptying
Filling
Foot pedal connection
Do not allow fingers to come into contact with moving parts
Flow direction
44
Minimum tank level indicator
Maximum tank level indicator
Degree of protection against water permeability
USB connector
HDMI connector
Thermal disinfection
135°C
Sterilizable at up to 135°C in the autoclave
Do not re-sterilize
STERILIZE
Do not re-use
Do not use if package is damaged
Refer to instruction manual
Content
STERILE
EO
Sterilized using ethylene oxide
Use by
Danger
Table 11
45
16. APPENDIX
16.1. PROBE COMPATIBILITY TABLE
Different probe sizes are available to allow effective treatment with the most popular endoscopic systems for percutaneous nephroscopy, rigid and semi-rigid ureteroscopy and cystoscopy:
PROBE DIAMETER
AND LENGTH
MINIMUM
ENDOSCOPE
WORKING CHANNEL
SIZE
MAXIMUM
ENDOSCOPE
WORKING CHANNEL
LENGTH
TAG RING
COLOR
Ø 1.1 mm x 425 mm
4 Fr
400 mm
RED
Ø 1.1 mm x 520 mm
4 Fr
500 mm
RED
Ø 1.1 mm x 625 mm
4 Fr
600 mm
RED
Ø 1.5 mm x 350mm
5 Fr
400 mm
ORANGE
Ø 1.9 mm x 341 mm
6 Fr
320 mm
YELLOW
Ø 3.4 mm x 340 mm
10.5 Fr
320 mm
GREEN
Ø 3.4 mm x 445 mm
10.5 Fr
420 mm
GREEN
Ø 3.9 mm x 350 mm
12 Fr
330 mm
BLUE
Ø 3.9 mm x 440 mm
12 Fr
420 mm
BLUE
Table 12
16.2. FCC AND IC
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation.
Any changes or modifications not expressly approved by Electro Medical Systems for compliance could void the user’s
authority to operate this equipment.
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15
of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the
equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to
radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which
case the user will be required to correct the interference at his own expense.
FCC RF exposure statement:
Important note: This device complies with FCC and Industry Canada radiation exposure limits set forth for general
population. This device must not be co-located or operating in conjunction with any other antenna or transmitter.
46
IC Statements:
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following
two conditions:
(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause undesired operation of the device.
Under Industry Canada regulations, the radio transmitter(s) in this device may only operate using an antenna of a
type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated
power (e.i.r.p.) is not more than that necessary for successful communication.
47
FB-610/13 draft_rev_A-01 ed.2017/09
© Copyright EMS SA
D istribute d by:
B o s to n S cie n tif ic Co r p o ra t i o n
3 0 0 B o s to n S cie nt i f i c Wa y
M a r lb o ro ug h , M A 0 1 7 5 2
Cu s to me r S e r v ice 1 - 8 8 8 - 2 7 2 - 1 0 0 1
Ma nufac ture d by:
EMS Ele c tro M e d i ca l Sy s te m s S A
C h. d e la Vua r p il l i è re 3 1
C H -1 2 6 0 N yo n - S WI T Z E R L A N D

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