APEX Lithosplit

LITHOSPLIT 4.
1 DIGITAL
DIGITAL INTRA CORPOREAL
PNEUMATIC LITHOTRIPSY SYSTEM
Operations Manual
V 5.2
FOREWORD
This manual is an essential part of your lithotripsy system and should be

kept with the system at all times. Please read this manual carefully and
review it from time to time. It contains important information on safety,
operations and maintenance.
Apex MediTech
All information in this manual is based on the latest product information available at
the time of publication. Due to improvements or other changes, there may be
discrepancies between information in this manual and your system. Apex reserves
the right to make changes at any time without notice.
This system may not comply with standards or regulations of other countries. Before
attempting to use this system in any other country, check all applicable regulations.
IMPORTANT
WARNING / CAUTION / NOTE
Please read this manual and follow its instructions carefully. To
emphasize special information, the words WARNING, CAUTION and
NOTE have special meanings. Information following these signal words
should be carefully reviewed.
⊗ WARNING
The personal safety of the operating surgeon, patient or bystanders may
be involved. Disregarding this information could result in their injury.
∆ CAUTION
These instructions point out special service procedures or precautions
that must be followed to avoid damaging the system.
! NOTE
This provides special information to make operation / maintenance
easier or important instructions clearer.
www.apex-meditech.com 1
INDEX
Sr. Chapter Page
1. Introduction 3
2. Unpacking 4
3. Indications & Contraindications 5
4. Setting-up 6
5. Operation 15
6. Mastering LITHOSPLIT 4.1 DIGITAL 16
7. Maintenance 19
8. Trouble shooting 21
9. Accessories & Spares 24
10. Specifications 25
11. Symbols 26
12. Contact details 28
13. Notes 29
⊗ WARNING
Read the manual carefully before operating the system. The system is to
be operated by the qualified Surgeons only.
1. INTRODUCTION
• Congratulations for being a proud owner of LITHOSPLIT 4.1

DIGITAL.
• LITHOSPLIT is an Intracorporeal Pneumatic Lithotripsy system.

It is used to fragment stones in the Kidney, Ureter and Bladder.
This is a form of “Direct Contact Lithotripsy”, wherein
fragmentation is achieved by direct contact of a pneumatically
driven probe onto the stone. The most striking features of
LITHOSPLIT 4.1 are its effectiveness and safety. Since there is
no heat generation during its use, there is no chance of any
thermal injury to mucosa. This is as opposed to Ultrasonic
Lithotripsy where a lot of heat is generated at the probe thereby
increasing the risk of damage to Urothelium.
• The Probe excursion is limited to 1.0 - 1.5 mm, hence there are
practically no chances of perforation on accidental contact with
the mucosa.
• The system is lightweight, portable, rugged and virtually

maintenance free, with extremely low running cost. A source of
pneumatic drive is provided through an ordinary Oxygen
Cylinder, which is available in all Operation Theaters. The
pressure is constantly monitored and the impact pulses are
regulated through a State-of-the-Art DIGITAL Micro Controller to
achieve optimum performance at all times.
• Probes are available in various sizes (0.8, 1.0, 1.1, 1.5 and 2.0
mm) to fragment stones at different sites. Even the hardest stones
can be effectively fragmented with these probes. Operating
Energy Level and Frequencies of Impacts (selection of ten
frequencies) can be varied to treat stones of different sizes and
hardness.
• The system is very easy to assemble and operate. The Hand

Piece is lightweight and can be assembled by Para Medical Staff.
2. UNPACKING
Open the case and take out all items from the thermocole box. Inspect
all items for any damage in transit.
1.Check List for the system :
•LITHOSPLIT 4.1 Control Unit 1 no.
•Hand Piece with tube and Probe Cover for 2.0 1 set
mm Probe
•Probe Cover for 1.0 mm Probe 1 no.
•Sterilisation Cover 1 no.
•Probe 1.0 mm 1 no.
•Probe 2.0 mm 1 no.
•Foot Switch (Pneumatic) 1 no.
•Regulator for Oxygen Cylinder 1 no.
•Tube for Oxygen Regulator with connector 1 set
•Spanner for fitting a Regulator on a cylinder 1 no.
•Key for operating a Cylinder 1 no.
•Spare “O” Ring 2 no.
•Spare Silicone Spring 2 no.
•Silicone Dam 2 no.
•Operations Manual with Demo Video CD 1 no.
•Case to store and carry the system 1 no.
∆ CAUTION
Do not try to operate the system if there is any visible damage. Report the
manufacturer immediately if there is any damage or any missing item.
! NOTE
Detachable flexible Mains Cable is not included in the system. Panel
mounting IEC C14 inlet for three wire detachable cable is provided for
connection to the mains.
3. INDICATIONS & CONTRAINDICATIONS
Indications:
Kidney Stone -> folic hypertension
Ureteric Stone -> Colic, frequency
Bladder stone -> retention, dysuria, haematuria
Urethral stone -> Retention.
Contraindications:
Severe urinary tract infections with stone
Severe Haematuria
Patient on anticoagulent prescribed
4. SETTING UP
LITHOSPLIT 4.1 Control Panel
4. SETTING UP
1. Connect the Regulator to the Oxygen Cylinder. A spanner is

provided to tighten the nut.
1
Tighten the nut properly to 2
avoid leakage. 3
2. The system can also be

connected to Central Oxygen 4
Supply giving an output at 2
kG/cm2
3. A female socket is provided

on the back of the Control Unit Regulator Assembly
1. Pressure Adjustment Key
for connection of Oxygen
2. Regulator
Cylinder. Insert & press the 3. Nut for fixing Regulator
tubing from the Regulator into 4. Oxygen Cylinder
Figure 1
the female socket on the back
of the Control Unit. Please
ensure that the tube is fully inserted in the socket.
4. Connect the Foot switch to the control Unit on the back as shown.
Please check the type of the Foot Switch you have received.
Pneumatic Foot Switch (if provided): A Pneumatic

Foot Switch works on a Pneumatic principle. It
sends a pneumatic signal to the Control Unit. The
Foot Switch unit is completely sealed to prevent
water entering into it. In case the Foot Switch is
detached from the Control Unit, please cover the
tube to prevent any foreign particles or liquid
entering.
4. SETTING UP
A connector as shown in the picture is provided on the

back side of the Control Unit if the Control Unit supports a
Pneumatic Foot Switch. The end of a Foot Switch tube
should be connected to the connector at the back of the
unit. Press the end of the tube firmly and ensure that the
tube is latched in the connector.
Electrical Foot Switch (if provided) : An

Electrical Foot Switch has a cable and
connector to transmit electrical very low voltage
and safe signal.
To prevent any damages to the Foot Switch,

please wrap a Foot Switch in a poly bag. This
will prevent water entering into it.
A connector for an Electrical Foot Switch is provided on the

back side of the Control Unit if the Control Unit supports an
Electrical Foot Switch. Insert and press the Plug connected
at the end of the cable fully into the connector.
4. SETTING UP
∆ CAUTION
An Electrical Foot Switch should be wrapped in a poly bag to avoid any
liquid entering into it. An Electrical Foot Switch may be damaged
permanently if any liquid enters into it.
5. Disassemble the Hand Piece and reassemble the same while

ensuring that it is dry and clean. Please refer the next page for
assembly and dis-assembly of hand piece.
Normal Flared
Probe Probe
Button Button
6. Probe buttons flare after a long use. The
chances of early flaring are more if the input gas
pressure is on higher side. Before each use,
check the button of the probe for such flaring. In
case it is flared, discard the probe and DO NOT
use it. If such probe is used, the probe will be
locked inside the hand piece which might
damage the hand piece permanently. DO NOT
use a probe having a flared button at the
bottom.
∆ CAUTION
A Silicone Spring and a Probe are essential parts of the Hand Piece,
even for conducting a test. DO NOT operate the system without inserting
those parts into the Hand Piece. Also DO NOT operate the system
before the Hand Piece is completely & properly assembled. The Hand
Piece may get damaged if operated without a Probe or a Silicone
Spring.
4. SETTING UP
4. SETTING UP
7. Assembly of the Hand Piece (refer Figure 3 & Figure 4)
This way
Attach Tube Insert piston here

from Control Unit
Figure 4
• Put the Piston in the Cylinder. The piston

can only be inserted from the side, which For 2.0mm Probe
goes into the Inlet.
• Insert the Cylinder in the Inlet fully as
shown in the figure 4.
• Place the “O” Ring on the Inlet.
• Fix the Cylinder Cover on the Inlet by For 1.1mm Probe
screwing.
• Select a Probe of desired size. Insert a
Silicone Spring over a Probe. Select a
Probe Cover as shown in Fig.5 matching
the Probe. Insert the Probe in the Probe For 0.8mm Probe
Cover from thread side. Place “O” Ring
on the Probe Cover.
• Fix the Probe Cover on the Cylinder
Cover by screwing. In case the Probe
Figure 5
Cover is not getting screwed fully,
unscrew the Cylinder Cover from Inlet by
3 to 4 turns, screw the Probe Cover fully, and screw the Cylinder
Cover on Inlet. Slide the Silicone Dam over the Probe and keep it
near the Probe Cover as shown in figure 3. This will prevent the
water entering into the Hand piece.
• Fit one end of soft tube to the Hand Piece and the other end to
the hose nipple provided on the Control Unit on the front.
4. SETTING UP
6
5
4
3
2
1
4. SETTING UP
Suction Assembly for PCNL (Optional)

• Assemble the Suction Assembly as shown in the figure 6
• Make sure that the silicone washer is in proper place
8. Connect the Mains Cable to the Mains supply of 230 V AC and the
socket provided on the back of the Control Unit. Do not modify the 3
Pin plug to 2 Pin plug.
9. Unscrew the Pressure Control Key on the Regulator fully (if provided
on the regulator). Open the Oxygen Cylinder. Make sure that the
Oxygen Cylinder is fully opened with the key and the
sufficient quantity (pressure) of gas is available to
perform the operation. Rotate the Key (if provided on
the regulator) clockwise to set the pressure at 3
kG/cm2. Please note that the Preset type Regulators
are not provided with a key for setting. In that case, the
output pressure remains in between 3 & 4 kG/cm2
automatically. Set the Energy Level on the control unit
to 4 using the Keys provided below the Energy Level
Display. (Recommended Energy Level to start is 4, however you
may increase it up to 8 to treat very hard stones).
10. Select the Frequency of impacts with the Keys provided below the
Frequency Display on the front of the Control Unit. The
system is packed with Ten Frequencies of impacts. The
Frequency “0” represents MONO mode. Frequencies 1
– 9 are repetitive frequencies of impacts from slow to
very high. To change the set value, press the Key once,
release it and press once more to further change the
value. The system will not go on changing the values if
you keep the key pressed. It will change once with
every Key stroke.
11. Switch On the power by Power Switch provided on

the front of the Control Unit.
Figure 11
Power Switch
4. SETTING UP
12. The Microcontroller goes into self test mode and checks the entire
electronic system. It takes about 4 seconds for the same. Till then
DO NOT disturb the self test by pressing the Foot Switch.
13. The “Foot Switch” Red Indicator Lamp will glow if the
Foot Switch is short-circuited at the time of power on. The
system won’t function in that case. This feature is
specially introduced to prevent any accidental operation
of the system. If you have pressed the Foot switch at
power on, release it to start working of the machine normally.
14. In case of any other system fault, the Warning indicator will
glow.
15. The Green “READY” Lamp will glow constantly after the test
is over indicating that the Control Unit is working well and the
system is ready for the operation.
Now the system is ready for operation.
⊗ WARNING
Before switching the Power Supply ON, confirm that the Hand Piece is
properly assembled. Do not open (disassemble) the Hand Piece if the
Power Supply is ON. The piston may fly off from the Hand Piece with full
force.
⊗ WARNING
DO NOT press any keys on the control panel at the time of startup (power on).
Pressing the keys at the startup may deteriorate the functions of the device and may
damage the device permanently.
5. OPERATION
1. Before starting the surgical procedure, confirm that the Hand Piece
is properly assembled and the system is working well. To confirm the
same, hold the Hand Piece in hand firmly such that the Probe will not
be in contact with any part of any object or a human being and
press the Foot Switch for a while. The Frequency “0” represents
MONO mode. If the selected frequency is other than “0”, the
machine will operate as long as you keep the Foot Switch pressed.
In case of MONO (“0”), the machine will operate only once, the
moment you press the Foot Switch. To operate the machine once
again, release the Foot Switch and press it again. You will hear the
sound of the piston striking the base of the probe indicating that the
system is working.
2. Insert the probe through the scope such that the probe will be in
contact with the stone. Select the desired frequency (refer chapter 5
for more details), and press the Foot Switch to operate the system.
3. Open & close the hole with index finger to control the suction.
4. Sterilization
• The Probes can be sterilized with
Ethylene Oxide, by immersing in
Gluteraldehyde 2% or Formalin
vapour.
Figure 15
• The Hand Piece can be sterilized with
Ethylene Oxide, by immersing in
Gluteraldehyde 2% or Formalin vapour. Before immersing the
Hand Piece, fix the sterilization cap in place of the Probe Cover.
Do not forget to place both the “O” Rings (on Inlet as well as on
the Sterilization Cap). Dry it thoroughly with a clean cloth
before use. Fit the soft supply pipe on the Hand Piece and keep
its other end hanging outside the liquid tray.
∆ CAUTION
Do not allow the irrigation fluid to enter the Hand Piece during operation. The
Piston may get jammed if water enters the Hand Piece (refer chapter 7,
Trouble Shooting).
6. MASTERING LITHOSPLIT
1. Selecting a Probe
• Treating Ureteric Stone
Probe of 1.0 mm is supplied as a standard accessory for use with
Ureteroscopes. Probes of 0.8 mm can also be supplied on
specific request. Select a Probe of maximum possible diameter,
which can be passed through your scope easily. The movement
of the Probe in the scope should be free. A bigger Probe
diameter will help you in decreasing the procedure time.
• Per Cutaneous Nephro Lithotripsy (PCNL)

For treating kidney stones, 2.0mm Probe is supplied as a
standard accessory.
• Treating Bladder Stones

For treating bladder stones, 2.0mm Probe is supplied as a
standard accessory. In case you are using a specially developed
Bridge for treating a Bladder Stone with the use of Cystoscope,
you may use 1.6mm Probe.
2. Selecting a Frequency
• Treating Ureteric Stones
To prevent the stones in the upper ureter from flying back into the
kidney, use of Frequencies - 2 to 4 during initial fragmentation
is recommended. For further fragmentation in small particles,
reduce the Frequency to MONO (“0”) or 1.
• Treating Kidney or Bladder Stones

Use of Frequency 4 or 5 is recommended for maximum power
and faster initial fragmentation. For further fragmentation, reduce
the Frequency to 3 or 2.
3. Selecting the Energy Level

The recommended Energy Level to start is 4. The Energy Level
ultimately decides the energy to be applied to the stone for
fragmentation. Select the Energy Level depending upon the
hardness of the stone. The hard stones require more energy for
fragmentation. The hard stones are generally black in colour,
laminated. To treat these stones, Energy Level can be set to 7 or 8.
For average stones, Energy Level 4 is recommended.
4. Getting a breakthrough
Sometimes even at the high Energy Level it may take more time for
initial fragmentation. Consistent application of high energy on the
stone helps you in initial fragmentation. You will find it easy to
fragment further. Make sure that the Probe is directly in contact with
the stone before pressing the Foot Switch. Maintain good vision by
free flow of irrigant solution at all times.
5. To prevent the ureteric stones from flying up during fragmentation,

following steps are recommended :
A. Dilate the lower ureter with balloon or ureteric dilator even while
using the mini ureteroscope. This will allow free flow of the
irrigant from the ureter to the bladder.
B. Keep the flow of the irrigant to the minimum i.e. just enough to
visualise the stone and the probe.
C. If it is possible to get above the stone, it is advisable to break the
proximal portion of the stone first.
D. Make the initial impacts on the periphery of the stone rather than
in the centre.
E. Give Head-up position & a diuretic just prior to starting the

procedure
F. Open a stone basket above the stone to trap migrating fragments
6. Special tips for treating Bladder Stones

Even large bladder stones can be treated with the LITHOSPLIT 4.1.
This can be done through a Nephroscope passed per urethra. The
Nephroscope can also be passed into the bladder with the following
procedure to avoid urethral trauma:
• Fill the bladder
• Take a Trocar cannula
• Slide 30F Amplatz Sheath over the Trocar cannula
• Puncture the bladder in the suprapubic region with the Trocar
with visual control through a cystoscope looking at the anterior
bladder wall and slide the Amplatz Sheath into the bladder.
• Withdraw the Trocar and introduce a Nephroscope through the
Amplatz Sheath.
• Break the stone with the LITHOSPLIT 4.1 under direct vision and
evacuate all the fragments.
• After the procedure is over, pass a renal dilator through the
Amplatz Sheath and remove the Amplatz Sheath leaving the renal
dilator in the bladder.
• Pass a half sheath alongside the dilator into the bladder and
remove the dilator.
• Pass 18 or 20F Foley’s Catheter through the half sheath, inflate
the balloon and remove the half sheath.
• Hitch up the Foley’s Catheter against the puncture in the anterior
bladder wall to prevent extravesicle leak.
! NOTE
In case of very hard stones, during the initial 15 to 20 impacts, you may find
nothing much is happening to the stone. However, if persistent impacts are
made, you will find that the stone will suddenly break up into fragments.
Thereafter, fragmentation proceeds at a much faster rate.
7. MAINTENANCE
1. Storage
After the completion of the procedure, please follow the steps given
below
• Close the Cylinder valve by turning the valve key clockwise. Make
sure that the valve is closed fully.
• Disconnect the Hand Piece from the Control Unit by
disconnecting the Hand Piece tube from the Control Unit.
• Press the Foot Switch to operate the Control Unit for releasing the
internal pressure till the pointer on the Pressure Regulator Gauge
returns to “0”.
• Switch Off the Control Unit by pressing the Power Switch.
• Detach the mains cable
• Release the Inlet Pipe from the Control Unit by sliding the blue
ring on the coupling towards the Control Unit.
• Disconnect the Foot Switch from the Control Unit.
• Rotate the Regulator key anti clockwise to prevent accidental
increase in pressure in the system when you connect the cylinder
to the Control Unit next time (Not applicable for the Preset Type
Pressure Regulator).
2. Routine Maintenance
• Dismantle the Hand Piece completely and clean all parts in-
cluding the Probe in running water. Do not use any harsh deter-
gents to clean. Light detergents like Car shampoo or a liquid
soap used for washing silk clothes can be used sometimes for
cleaning the Hand Piece parts. Soft nylon brush can be used to
clean Cylinder, Probe Cover and Inlet from inside. Do not loose
the Piston since it is very important and critical part in the Hand
Piece assembly. Wash all parts thoroughly in running water to
remove any trace of salts.
• Wipe all the parts with soft muslin cloth. Always keep all parts
clean and dry.
7. MAINTENANCE
• Do not allow water to enter into the Foot Switch. You may wrap it
in a plastic bag. In case you find water entering into the Foot
Switch, disconnect the switch from the Control Unit and remove
the water from it. Clean and dry the switch with a piece of cloth.
Entry of water into the switch may hamper the working of the
system.
⊗ WARNING
No user serviceable parts are inside the Control Unit. Do not open the
Control Unit. Touching the live parts inside the system will lead to
electrocution. Warranty voids if the seal is broken.
⊗ WARNING
Use ONLY the genuine spare parts and accessories manufactured by Apex
Meditech. Using duplicate, pirated or similar parts may cause serious injuries to user,
patient or other personnel. It may also deteriorate the functions of the device and
may damage the device permanently.
∆ CAUTION
Probe buttons flare after a long use. In case the input gas pressure is on
higher side the chances of early flaring the buttons are more. After each
use, check the button of the probe used for such flaring. In case it is
flared, discard the probe and DO NOT use it. If such probe is used, the
probe will be locked inside the hand piece which might damage the
hand piece permanently.
! NOTE
Put 2-3 drops of silicon oil in the coupling provided for connecting Hand
Piece and move the ring on the coupling to & fro for 2-3 times, once in a
month. This will ensure a smooth operation and latching of the plugs
in the coupling.
8. TROUBLE SHOOTING
1. System does not work
•All Indicator Lamps remain OFF when it is switched ON

• Check the mains connection. If the connection is poor, make it
firm.
• Check the fuse. If it is blown, replace it with 500 mA 5X20 mm,
Fast Acting fuse. (Spare fuse is provided in the Fuse Holder)
• Still the switch does not glow, contact the manufacturer.
•Green Indicator is ON
• Check that the Foot Switch is connected properly. If it is not
connected properly, remove the tube and reconnect.
•“Foot Switch” Red Indicator glows

• The glowing of “Foot switch Fault” Red Indicator Lamp
indicates that the Foot Switch is short-circuited.
• If the foot switch is pressed at the time of power on, to
avoid false triggering at the startup the system considers
it as a fault. Do not press the Foot Switch immediately after
switching ON the system (for about 4 seconds) till the Green
“READY” Indicator Lamp glows.
• If the Foot Switch is pressed at the startup, release it
and wait till the Green “READY” Indicator Lamp
glows.
•“Warning” Red Indicator glows

• If the system has an Electrical Foot Switch, the “Warning” Red
Indicator Lamp indicates that the Foot Switch is not connected.
• Check that the Foot Switch is connected properly. If it is not
connected properly, put the connector in the socket properly. Do
not press the Foot Switch till the Green “READY” Indicator Lamp
glows (for about 4 seconds).
8. TROUBLE SHOOTING
•Control Unit works (makes tapping noise when the Foot Switch is
pressed) but the energy is not transferred to the Probe, Check that
• the Oxygen Cylinder is connected properly to the Control Unit.
• the Cylinder has got enough pressure. The pressure inside the
oxygen cylinder which is seen on the primary pressure gauge is
at least 40 kG/cm 2.
• the oxygen cylinder valve is fully opened. Rotate the cylinder
valve key counter-clockwise at least 2 full turns.
• the Pressure Gauge on the Control Unit shows pressure in the
permitted range. (Adjust the pressure by rotating the key on the
regulator or the knob on the control unit, if not adjusted
previously)
• the Hand Piece assembly is correct. Confirm that the Piston &
Silicone Spring are present in the assembly.
• the Hand Piece Cylinder is inserted in the Inlet as described in
the Chapter 4
• the Probe is intact & not broken.
• water is not present inside the Hand Piece
• the Piston is moving freely
• the Hand Piece is connected properly to the Control Unit.
Still the system does not work, contact the manufacturer.
2. The system works with inadequate output power

• Check the primary Pressure Gauge showing the pressure in the
Oxygen Cylinder shows adequate pressure else replace the
Cylinder.
• Check the Energy Level on the Control Unit is adequate for
fragmenting the stone. If not, adjust the Energy Level to set the
desired Energy.
• Check that the Cylinder and Piston are dry and clean. If not clean
the same in running water and dry them thoroughly before trying
again.
• Check that the Probe is intact & not broken else replace the
Probe.
• Check that the Silicone Spring is in its place and it is not worn
out.
8. TROUBLE SHOOTING
3. The system works well for few impacts only

• Check that the Valve of the Oxygen Cylinder is opened fully. As
you open the valve slightly, the gauges show the pressure
immediately even if it is opened partially.
4. The tube of the Regulator is not getting latched in the coupling

• Put 2-3 drops of Silicon Oil in the coupling and move the blue
ring on the coupling to & fro for 2-3 times.
⊗ WARNING
No user serviceable parts are inside the Control Unit. Do not open the
Control Unit. Touching the live parts inside the system will lead to
electrocution. Warranty voids if the seal is broken.
∆ CAUTION
Contact the manufacturer if there is any difficulty in operating the system
even after the above mentioned care is taken.
9. OPTIONAL ACCESSORIES & SPARES
Sr. Particulars Part Code

1. LITHOSPLIT 4.1 DIGITAL Control Unit FG0111
2. LITHOSPLIT Super Hand Piece without FG0102
Probe & Supply Pipe
3. Sterilisation cover HP0106
4. Piston for LITHOSPLIT Super Hand Piece HP0105
5. Cylinder for LITHOSPLIT Super Hand HP0109
Piece
6. Tubing with plug for Hand Piece PP0101
7. O Ring 6X2 HP0202
8. O Ring 13X2 HP0201
9. Probe 0.8 mm (for Ureter) PB0301
11. Probe 1.1 mm Dual Purpose (for Ureter) PB0302
13. Probe 1.5 mm (for Bladder) PB0304
14. Probe 2.0 mm (for Kidney & Bladder) PB0305
15. Silicone Spring HP0202
16. Foot Switch with tube (Electrical) FS0101
17. Foot Switch with tube (Pneumatic) FS0102
18. Regulator with tubing & plug RG0101
19. Suction Assembly for PCNL SU0101
20. Washer for Suction Assembly SU0102
21. Bridge for bladder stones BG0101
22. Adapter for Ureteroscope AD0101
23. Carrying case with thermocole CS0101
24. Operations Manual along with a IM0104
Demonstration Video CD
! NOTE
Please quote the Part Code while ordering the accessories or spares.
10. SPECIFICATIONS
1. Control Unit Based on Ultra High Speed Micro

Processor
• Supply Voltage ~ 91-256VAC, 50/60Hz,
• Power 19VA (max)
• Fuse 500mA, 5X20mm, Fast Blow
• EN60601-1 Class II
• EN60601-1 Type BF
• Power entry Panel mounting IEC C14 inlet for three
wire detachable cable.
• Frequencies of Impacts Single (Mono) & Nine Multiple
(programmable through Key on front)
Total Ten choices
• Input Pressure max. 4 kG/cm 2
• Output Pressure 0-4 kG/cm2 (Input Pressure <=4kG/cm 2)
• Energy Level 1 to 8 (programmable through Key on
front)
• Input gas Compressed air or Compressed
Oxygen
• Operating temperature 15º - 35º C
• Dimensions 85 mm H X 225 mm W X 230 mm D
• Weight 1.9 kG
• Degree of protection IP20
• Relative Humidity 30 ~ 75% non-condensing
• Atmospheric Pressure 700 ~ 1060 hPa
2. Hand Piece
• Input Pressure Controlled by the Control Unit
• Dimensions 220 mm L (without Probe), 18 mm Dia.
• Weight 140 gms (without Probe)
• Sterilization methods Ethylene Oxide, Formaldehyde or
Gluteraldehyde 2%
11. SYMBOLS
Indicates the name and address of the

manufacturer
The unique serial number of the product
Alerts the user to consult the accompanying

document fro important instructions regarding
the operation, maintenance and possible safety
hazards if any.
Indicates the temperature limitation for use of the

equipment. The minimum temperature should be
15º C and maximum temperature should be 35º
C for operating the equipment
The operating voltage range, type of current and

frequency
Replaceable cartridge fuse link rating
Degree of protection provided against the

intrusion of solid objects, dust, accidental
contact, and water in the enclosure.
Functional Earth
Applied part ‘BF’
Insulation Class II
Sitting prohibited, For table top EUT
11. SYMBOLS
Energy level setting, low to high
Hand piece energised
Connection to Hand Piece
Frequency of operation
Connection to Foot Switch
Power off
Power On
Compressed gas inlet with the maximum

pressure limit
CE Mark (with Notified Body number)
Attention
EU Representative
Refer IFU
12. CONTACT DETAILS
Apex Meditech,
"Siddhivinayak", Maheshwari Soc.,
Sahakar Nagar No.2,
Pune 411 009. India.
Tel. : ++91 (20) 24222630, 24222634
Email : Sales@Apex-Meditech.com
Mr. Andrew Hague

of CellSonic Limited,
19 Tinker Lane, Crookes,
Sheffield, S10 1SE,
United Kingdom
13. NOTES
Printed in India

APEX Lithosplit

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

APEX Lithosplit

Uploaded by

Copyright:

Available Formats

LITHOSPLIT 4.

This manual is an essential part of your lithotripsy system and should be

Sr. Chapter Page

3. Indications & Contraindications 5

6. Mastering LITHOSPLIT 4.1 DIGITAL 16

9. Accessories & Spares 24

12. Contact details 28

• Congratulations for being a proud owner of LITHOSPLIT 4.1

• LITHOSPLIT is an Intracorporeal Pneumatic Lithotripsy system.

• The system is lightweight, portable, rugged and virtually

• The system is very easy to assemble and operate. The Hand

1.Check List for the system :

•LITHOSPLIT 4.1 Control Unit 1 no.

Ureteric Stone -> Colic, frequency

Bladder stone -> retention, dysuria, haematuria

Urethral stone -> Retention.

Patient on anticoagulent prescribed

LITHOSPLIT 4.1 Control Panel

1. Connect the Regulator to the Oxygen Cylinder. A spanner is

2. The system can also be

3. A female socket is provided

Pneumatic Foot Switch (if provided): A Pneumatic

A connector as shown in the picture is provided on the

Electrical Foot Switch (if provided) : An

To prevent any damages to the Foot Switch,

A connector for an Electrical Foot Switch is provided on the

5. Disassemble the Hand Piece and reassemble the same while

7. Assembly of the Hand Piece (refer Figure 3 & Figure 4)

Attach Tube Insert piston here

• Put the Piston in the Cylinder. The piston

Suction Assembly for PCNL (Optional)

11. Switch On the power by Power Switch provided on

Now the system is ready for operation.

• Per Cutaneous Nephro Lithotripsy (PCNL)

• Treating Bladder Stones

• Treating Kidney or Bladder Stones

3. Selecting the Energy Level

5. To prevent the ureteric stones from flying up during fragmentation,

E. Give Head-up position & a diuretic just prior to starting the

6. Special tips for treating Bladder Stones

1. System does not work

•All Indicator Lamps remain OFF when it is switched ON

•“Foot Switch” Red Indicator glows

•“Warning” Red Indicator glows

Still the system does not work, contact the manufacturer.

2. The system works with inadequate output power

3. The system works well for few impacts only

4. The tube of the Regulator is not getting latched in the coupling

Sr. Particulars Part Code

1. Control Unit Based on Ultra High Speed Micro

Indicates the name and address of the

The unique serial number of the product

Alerts the user to consult the accompanying

Indicates the temperature limitation for use of the

The operating voltage range, type of current and

Replaceable cartridge fuse link rating

Degree of protection provided against the

Applied part ‘BF’

Sitting prohibited, For table top EUT

Energy level setting, low to high

Hand piece energised

Connection to Hand Piece

Connection to Foot Switch

Compressed gas inlet with the maximum