LMA Stone Breaker User manual

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DA
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DE
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EL
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HU
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LMA Stone Breaker™
PNEUMATIC LITHOTRIPTER
LMA Stone Breaker™
PNEUMATICKÝ LITOTRYPTOR
LMA Stone Breaker™
TRYKLUFTDREVET LITHOTRIPTER
LMA Stone Breaker™
PNEUMATISCHER LITHOTRIPTOR
LMA Stone Breaker™
ΣΥΣΚΕΥΗ ΛΙΘΟΤΡΙΨΙΑΣ ΠΕΠΙΕΣΜΕΝΟΥ ΑΕΡΑ
LMA Stone Breaker™
LITOTRIPTOR NEUMÁTICO
LMA Stone Breaker™
LITHOTRIPTEUR PNEUMATIQUE
LMA Stone Breaker™
PNEUMATIKUS KŐZÚZÓ
LMA Stone Breaker™
LITOTRITORE PNEUMATICO
LMA Stone Breaker™
PNEUMATISCHE LITHOTRIPTOR
LMA Stone Breaker™
PNEUMATISK STEINKNUSER
LMA Stone Breaker™
PNEUMATYCZNY LITOTRYPTOR
LMA Stone Breaker™
LITOTRIPTOR PNEUMÁTICO
LMA Stone Breaker™
PNEUMATISK LITOTRIPTOR
LMA Stone Breaker™
气动碎石器

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ENGLISH
DEVICE DESCRIPTION 2
Introduction 2
Components and Accessories 2
WARNINGS AND CAUTIONS 3
INTENDED USE 3
INDICATION FOR USE 3
ADVERSE EFFECTS 3
PREPARATION FOR USE 3
Preparation for Cleaning, Disinfection and Sterilisation 3
Cleaning 4
Disinfection 4
Sterilisation 4
PROCEDURE 4
General 4
Pre-use Preparation 4
Intracorporeal Lithotripsy Procedure 4
MAINTENANCE 5
EFFECTS ON ENVIRONMENT 5
RETURN TO MANUFACTURER 5
MANUFACTURER’S WARRANTY 5
TROUBLESHOOTING 6
TECHNICAL DATA 7
LMA StoneBreaker™ and Probes 7
LMA StoneBreaker™ CO2Cartridge 7
Copyright © The Laryngeal Mask Company Limited, 2009
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means
electrical, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher. LMA, LMA StoneBreaker, The
Laryngeal Mask Company Limited logo and its component parts are trademarks of The Laryngeal Mask Company Limited. The information
given in this document is correct at the time of going to press. The manufacturer reserves the right to improve or modify the products without
prior notification.

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LMA StoneBreaker™ DEVICE DESCRIPTION
Introduction
The LMA StoneBreaker™ is a portable, non-electrical, compact intracorporeal lithotripter, intended for use to fragment stones in the urinary
tract (i.e. kidney, ureter and bladder). It weighs around 500g with a probe and it requires no extraneous electrical or pneumatic connections.
It is powered by a detachable cartridge of high pressure carbon dioxide gas, with a maximum pre-adjusted operating pressure of 31 bar. The
mechanical shock generated by the device is transferred as kinetic energy through the length of the probe to the tip, which is in direct contact
with the stone to be fragmented. The advantage of delivering high pressure at contact is to allow expeditious fragmentation, thereby reducing
operative time. There is very little movement of the probe itself, allowing for safe stone fragmentation.
A LMA StoneBreaker™ carbon dioxide (CO2) gas cartridge typically provides the necessary energy for one surgical procedure. Once the cartridge
is perforated by the built-in screw system,the compressed gas passes through a pre-adjusted pressure regulator in the device and a mechanical
shockwave required for fragmentation of urinary stone is generated when the trigger is depressed. Expended gas will leave the device through
a specially designed exhaust port and the attached exhaust line. The trigger snaps back to its starting position when the gas is expended
through the exhaust port, and the device is now ready for further use.
One full LMA StoneBreaker™ carbon dioxide gas cartridge should allow delivery of at least 80 shocks. The cartridge must be removed from the
device after the completion of the surgical operation to allow complete release of gas from the cartridge.
The LMA StoneBreaker™ is recommended for use with endoscopes equipped with a straight working channel.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a practitioner licensed by state law to use such device.
WARNING: Please read this instruction manual carefully before using the LMA StoneBreaker™.
Components and Accessories
The LMA StoneBreaker™ device is made up of the following main components. (See Figure 1)
• Trigger – Generates the mechanical shockwave required for the fragmentation of the calculus.
• Probe Cap – This holds the probe in place.
• Cartridge Holder – This is to lock and hold the carbon dioxide gas cartridge in place.
• Carbon Dioxide Gas Cartridge –This is the energy source. The LMA StoneBreaker™ carbon dioxide gas cartridges, which are sterilised by Gamma
irradiation and are supplied separately from the device, are surface-sterile only, the gas within the cartridge is not sterile.
CAUTION: The gas cartridge must be removed from the device after the completion of each surgical procedure.
• Exhaust Port – This is for the exhaust of expended carbon dioxide gas from the device.
• Exhaust Line – This flexible tube is attached to the exhaust port to lead the expended gas away from the field of operation.
• Probe – The LMA StoneBreaker™ Probes are supplied in separate stand-alone packaging. The probes are single-use and are sterilised by Gamma
irradiation.
Table 1 indicates the current LMA StoneBreaker™ Probes available for use with the device. Please refer to the product catalogue for the most
up-to-date available product range.
Table 1: Specification of LMA StoneBreaker™ Probes
Description Diameter Total Length
Probe 1.0 mm 1.0 mm (3 Fr) 500 mm (19.7")
Probe 1.0 mm 1.0 mm (3 Fr) 605 mm (23.82")
Probe 1.6 mm 1.6 mm (4.8 Fr) 500 mm (19.7")
Probe 1.6 mm 1.6 mm (4.8 Fr) 605 mm (23.82")
Probe 2.0 mm 2.0 mm (6 Fr) 425 mm (16.73")
Figure 1
Exhaust Line
O-Ring Probe
Cartridge Holder
CO
2
Cartridge
Device
T r igger
Probe Cap
Exhaust Port

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The following accessories are included with the LMA StoneBreaker™:
• Exhaust Cap – Closes the Exhaust Port to prevent moisture from entering the device during cleaning, disinfection and sterilisation.
• Sterilisation Cap – Replaces the carbon dioxide gas cartridge to prevent moisture from entering the device during cleaning, disinfection and
sterilisation.
CAUTION: Use only LMA StoneBreaker™ CO2cartridges and probes; the use of the wrong gas cartridges and/or probes can affect the
device performance and patient safety.
WARNINGS AND CAUTIONS
• The LMA StoneBreaker™ must be used only by specialists trained in endourology and should be used only for the purposes intended. In case of
malfunction or failure of the device, it is recommended that the surgeon has another unit (or other intracorporeal lithotripsy device) on standby
in order to complete the treatment scheduled at the time.
• It is recommended that urologists who have not used an intracorporeal lithotripter before, to execute a few manipulations in vitro with a stone
model in order to learn how to manipulate the device.
• Ensure that the probe tip does not exceed the endoscope channel at the time of introducing the endoscope into the urinary tract.
• The LMA StoneBreaker™ is delivered non-sterile and it must be cleaned, disinfected and sterilised before initial use and before each subsequent
use.
• For the LMA StoneBreaker™ Probe Single Use (sterile) : Do not use if the unit pouch has been previously opened or damaged.
• Do not use the single-use probe more than once. Re-usage of single-use probe increases the risk of patient injury, damage to device or
endoscope or may lead to device malfunction.
• For the LMA StoneBreaker™ carbon dioxide gas cartridge (sterile), do not use if the unit pouch has been previously opened or damaged.
• Do not use the LMA StoneBreaker™ or any of the accessories if they are damaged in any way.
• Do not use the LMA StoneBreaker™ Probe if the O-Ring is missing or if it is damaged in any way.
• It is recommended that extra probes should be available in case of malfunction.
• Ensure the probe size chosen is compatible with the endoscope’s working channel and appropriate for the clinical condition that is being
treated.
• Do not autoclave the carbon dioxide gas cartridge with the LMA StoneBreaker™.
• Never attempt to refill the empty carbon dioxide gas cartridge.
• Never attempt to transfer gas from one carbon dioxide gas cartridge to another.
• Never attempt to disassemble the device.
INTENDED USE
The LMA StoneBreaker™ is intended for the fragmentation of urinary (i.e. kidney, ureter, and bladder) tract stones.
INDICATION FOR USE
The LMA StoneBreaker™ is indicated for use via a rigid or semi-rigid endoscope with a straight working channel, for the fragmentation of
urinary (i.e. kidney, ureter and bladder) tract stones.
ADVERSE EFFECTS
There are no known recorded adverse effects with the use of the LMA StoneBreaker™. However, due to the movement of the endoscope and
high force generated by the LMA StoneBreaker™ device, there is the potential of tissue injuries, should the probe tip be in direct contact with
the mucosal membrane, causing perforation of tissue, pain, bleeding, renal damage and/or infection.
Review of published literature showed that adverse events that may potentially occur with the use of intracorporeal lithotripter include
perforation of the bladder or ureter, bleeding in urinary tract or blood in the urine, pain, renal damage and infection.
Breakage of probe during use, though unlikely, may potentially occur. The practitioner shall then determine the most effective way of
intervention, following all relevant procedures for such intervention.
PREPARATION FOR USE
Before each use, it is necessary to clean, disinfect and sterilise the LMA StoneBreaker™ device and exhaust line. Proper cleaning, disinfection and
sterilisation are essential to ensure continued safe use of the device and accessories.
NOTICE: The LMA StoneBreaker™ Probe Single Use (sterile) and LMA StoneBreaker™ carbon dioxide gas cartridge (sterile) are individually
packed, Gamma-sterilised and ready to use. The following procedure on cleaning, disinfection and sterilisation is not applicable to these sterile,
“ready-to-use” products.
Preparation for Cleaning, Disinfection and Sterilisation
Ensure the sterilisation cap and exhaust cap are screwed tightly in place at the cartridge holder and exhaust port respectively. This is to prevent
moisture from entering the device during cleaning,disinfection and sterilisation.
NOTICE: It is possible for moisture to adversely affect the effective performance of the device. If liquid has penetrated the device, return it to the
manufacturer for servicing.
The hospital’s own protocol for cleaning, disinfection and sterilisation of surgical instruments should be followed whenever possible. The
following is the recommended procedure for cleaning, disinfecting and sterilising the LMA StoneBreaker™ device and exhaust line.
Figure 2
Device
Exhaust Cap Probe Cap
Sterilisation Cap

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Cleaning
Ensure the probe is not attached to the device. If the probe is still present, unscrew the probe cap to remove the probe. Re-attach the probe cap
back onto the device. Refer to Figure 2.
Thoroughly wash the LMA StoneBreaker™ and its accessories by gently cleaning with a soft bristle brush in warm water using mild detergents
or enzymatic cleaning agents in accordance with the manufacturer’s instructions until all visible foreign matter is removed.
Thoroughly rinse the device and accessories in warm running tap water to remove cleaning residue. Carefully inspect to ensure that all
visible foreign matter has been removed. A specific cleaning agent found to be compatible with the LMA StoneBreaker™ and its accessories is
Endozime® (Ruhof, Valley Stream, NY).
Disinfection
Submerge the LMA StoneBreaker™ device and its accessories into a disinfectant solution in accordance to the manufacturer’s instructions.
CAUTION: Ensure the device is watertight by tightening the Sterilisation Cap and Exhaust Cap at their respective locations. One disinfecting
solution that is found to be compatible with the LMA StoneBreaker™ device and accessories is Cidex® OPA (Johnson & Johnson, UK). Submerge
the device and accessories into the Cidex® OPA at room temperature for at least 20 minutes. Thoroughly rinse the disinfected device with sterile
water and dry it.
Sterilisation
Steam autoclaving is the only recommended method for sterilising the LMA StoneBreaker™ device and exhaust line. The device and its
accessories should be placed in a suitable sterilisation bag prior to placing them in a steam autoclave. Steam autoclave the device and
accessories by following the recommendations of the hospitals or the autoclave manufacturer. All steam autoclave cycles typically used for
instruments and porous items are acceptable. One steam sterilisation cycle that is suitable for the LMA StoneBreaker™ device and exhaust line is
to expose the device and accessories to steam at 134°C with a hold time of at least 10 minutes.
WARNING: Do not sterilise the CO2cartridge in an autoclave as the cartridge will explode when heated.
CAUTION: After autoclave sterilisation, do not utilise the LMA StoneBreaker™ in a warm condition, as this may cause damage to the
components within. The following minimum cooling period is required: EITHER ambient air cooling period - 60 minutes minimum OR
sterile water cooling period – 5 minutes minimum.
PROCEDURE
General
The LMA StoneBreaker™ requires effective endoscope manipulation in order to ensure proper direct contact of the probe with the calculus,
with the probe tip protruding from the endoscope working channel by 10mm to 20mm maximum. The choice of the endoscope depends on
the position of the stone (kidney, ureter or bladder). The LMA StoneBreaker™ is recommended for use with a rigid or semi-rigid endoscope
equipped with a straight working channel, and to use the largest probe possible to allow transmission of maximum energy. Table 2 shows the
recommended diameter for the endoscope working channel with the respective LMA StoneBreaker™ probes.
Table 2: Recommended Endoscope Working Channel Diameter
NOTICE: It is recommended that for better and simplified alignment of the working channel and the LMA StoneBreaker™ Probe, endoscope
adaptors that are available from the endoscope manufacturers should be used. Each carbon dioxide gas cartridge should provide sufficient
energy for one typical procedure.
Pre-use Preparation
Prior to the use of the LMA StoneBreaker™ for stone fragmentation, it is recommended that the following checks are carried out:
• Check that the LMA StoneBreaker™ device and its accessories are not damaged in any way.
• For the LMA StoneBreaker™ Probe Single Use (sterile) and the LMA StoneBreaker™ carbon dioxide gas cartridge (sterile), check to ensure the unit
pouch is not damaged or previously opened. Do not use if the unit pouch is damaged or previously opened.
• Remove both the Sterilisation Cap and Exhaust Cap from the LMA StoneBreaker™ device.
• Attach the Exhaust Line onto the Exhaust Port.
• Check and ensure the O-Ring is in the correct position on the probe.
• Remove the Probe Cap from the device and insert the probe through the opening in the Probe Cap. Replace the Probe Cap to the device and
ensure that the probe does not move too freely.
• Insert a new LMA StoneBreaker™ carbon dioxide gas cartridge into the Cartridge Holder and tighten to hold the cartridge in place but NOT
perforating it.
CAUTION: Do NOT perforate the cartridge at this point. Leaving a perforated carbon dioxide gas cartridge in the device for too long
may adversely affect the performance of the device.
Intracorporeal Lithotripsy Procedure
Before the operation, tighten the cartridge holder until the cartridge is perforated. The trigger should now be under pressure. Turn the lever of
the cartridge holder a quarter rounds more to secure the cartridge to the device.
CAUTION: Check that the device is working correctly by depressing the trigger two to three times and ensure the trigger returns to
the original position every time the trigger is released. Position the Exhaust Line away from the head of the operator and ensure it is
properly attached to the Exhaust Port.
Probe Diameter Diameter of Endoscope Working Channel
2.0 mm (6 Fr) >2.33 mm (7 Fr)
1.6 mm (4.8 Fr) >1.83 mm to 2 mm
(5.5 to 6 Fr)
1.0 mm (3 Fr) >1.17 mm to 1.8 mm
(3.5 to 5.4 Fr)

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CAUTION: Exhaust Line disconnection from the Exhaust Port during use may indicate malfunction of the Pressure Regulator.
Position the probe, through the endoscope working channel, to be in direct contact with the stone.
CAUTION: Ensure proper alignment of probe and endoscope. Any misalignment may damage both the probe and endoscope.
It is recommended that the practitioner ensures that the tip of the probe remains in sight throughout the procedure.
CAUTION: Ensure the probe is extended beyond the tip of the endoscope by 10mm to 20mm to avoid damage to the endoscope.
When ready, hold the device firmly in place and depress the trigger of the LMA StoneBreaker™, which will generate the mechanical shock
required to fragment the targeted stone.
WARNING: Ensure minimal movement of the device and probe. Any significant movement of the device and probe during stone
fragmentation may result in direct contact of the activated probe with tissue resulting in tissue damage and / or bleeding.
Release the trigger and allow it to return to its original position after each depression.
CAUTION: If the trigger cannot be depressed, it may indicate malfunction of the Pressure Regulator.
For subsequent shocks, reposition the device and hold it firmly before depressing the trigger as required.
NOTICE: One new full LMA StoneBreaker™ carbon dioxide cartridge should allow delivery of at least 80 shocks.
Once the procedure is complete, remove the carbon dioxide cartridge from the Cartridge Holder by loosening the lever slowly. This will allow
any remaining gas in the cartridge to escape, thereby emptying the cartridge.
CAUTION: Do not sterilise the spent cartridge with the device.
MAINTENANCE
Though the LMA StoneBreaker™ is designed and manufactured to require minimum maintenance, proper care and maintenance are required
to ensure safe and effective use of the device. The manufacturer recommends that the device and its accessories be carefully checked upon
receipt and prior to each use to prevent injury to the patient or user. Follow the recommendations listed in this Instruction manual for proper
routine maintenance and care of the device.
Defective probes (such as the presence of kink, bent or dent marks along the length of the probe) should be discarded. Other components that
may be damaged and lose their efficiency in maintaining water-tightness of the device are the Sterilisation Cap and Exhaust Cap. Check the
integrity of these components before using them on the device.
EFFECTS ON ENVIRONMENT
This device does not contain any harmful components; follow local statutory requirements / instructions for proper disposal of the non-
functioning devices, probes and other accessories. Never dump the empty carbon dioxide cartridges at sea. The cartridge is made of zinc-plated
and chrome stabilised steel, and should be properly disposed in accordance with local statutory requirements and instructions.
CAUTION: Never dispose an unused carbon dioxide cartridge. Ensure that the cartridge is empty before disposal.
RETURN TO MANUFACTURER
Should there be a need to return the LMA StoneBreaker™ to the manufacturer for investigation or repair, please ensure the product is properly
cleaned, disinfected and sterilised in accordance to the recommendations listed in this instruction manual before shipment.
Please return device in its sterilisation bag (as evidence that the device is sterile), whenever possible. The manufacturer may refuse receipt
of device and / or accessories if it is found that the products are not properly disinfected or sterilised or there is no evidence that it has been
carried out.
MANUFACTURER’S WARRANTY
The manufacturer grants a one (1) year warranty from the date of invoice on the LMA StoneBreaker™. The manufacturer warrants the device
against faulty materials and manufacturing defects, provided that the device is used in accordance with the instructions set forth in the
instruction manual. If the device exhibits any such defects or damage, a new unit will be supplied. If covered by the warranty, this will be done
free of charge; otherwise the customer will be invoiced for the cost incurred. This warranty is void if damage is caused by the improper use or
treatment of the device, or damages due to external causes including accident, drops, alteration, or improper installation. Repair may only be
carried out by the manufacturer or any of its authorised service centres. The warranty covering the reliability and proper functioning of the
device is void if the user or any other unauthorised person tries to perform repairs. Single-use products are warranted against faulty materials
or manufacturing defects at time of delivery to customer. Warranty is applicable only if products are purchased from an authorised distributor.
The manufacturer disclaims all other warranties, whether express or implied, including, without limitation, the warranties of merchantability or
fitness for a particular purpose.

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TROUBLESHOOTING
Description Possible Causes Action
No shock generated CO2cartridge not perforated Tighten the cartridge holder
CO2cartridge is empty Replace cartridge
Device malfunction Return to manufacturer
Probe Cap not properly in place Tighten the probe cap
Trigger not fully depressed Depress trigger fully
Shock generated is weak or
without force
CO2cartridge is nearly empty Replace cartridge
CO2cartridge not perforated
properly
Tighten the cartridge holder
fully
Device malfunction Return to manufacturer
Gas leakage Cartridge not properly secured
in the cartridge holder
Tighten the cartridge holder
fully
Device malfunction Return to manufacturer
Shock generated has a very
long excursion
Probe O-Ring is missing or
damaged
Replace probe
No shock generated at
the tip of the probe, when
tested against a sterile
gloved finger
Probe O-Ring is missing or
damaged
Replace probe
Bad quality of the shock at
the tip of the probe
Probe O-Ring is missing or
damaged
Replace probe
Trigger activation too stiff or
difficult to depress
Pressure regulator may be
defective
Return to manufacturer
Trigger returns to original
position too slowly
Device malfunction Return to manufacturer
CO2cartridge is empty or nearly
empty
Replace with a new cartridge
Exhaust line constantly
gets disconnected from
exhaust port when trigger is
depressed
Pressure regulator may be
defective
Return to manufacturer
Exhaust line not properly attached
to exhaust port
Tighten exhaust line to
exhaust port
Black particles found inside
the exhaust line after use
Foreign particles present
within device, but the device is
functioning well
Change the exhaust line

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Operating mode Intermittent, manually controlled by user
Dimensions Device 246 mm x 80 mm
Probe Description
Probe 1.0 mm
Probe 1.0 mm
Probe 1.6 mm
Probe 1.6 mm
Probe 2.0 mm
Diameter
1.0 mm (3 Fr)
1.0 mm (3 Fr)
1.6 mm (4.8 Fr)
1.6 mm (4.8 Fr)
2.0 mm (6 Fr)
Length
500 mm (19.7")
605 mm (23.82")
500 mm (19.7")
605 mm (23.82")
425 mm (16.73")
Weight 500g
Conditions
for use
Temperature
range
+10°C to + 40°C
Relative humidity
range
30% to 70% RH
Transportation
conditions
Temperature
range
-10°C to + 45°C
Relative humidity
range
10% to 95% RH
TECHNICAL DATA
LMA StoneBreaker™ and Probes
LMA StoneBreaker™ CO2Cartridge
Content Pressurised carbon dioxide gas (99.5% Purity)
UN code 1013
Dimension Ø 19 x 83 mm
Weight 11.5 g
Conditions for Use Not higher than + 45ºC
Transportation conditions UN Code
UN Class
Classification code
UN 2037
2.2
5A
According to ADR chapter 3.2 schedule A column 6, the special provisions
191 and 303 apply: (transported product is not subject to the ADR, IMDG
or RID regulations)
Storage conditions Temperature range -30°C to + 45°C
Store in a well-ventilated area and in a location free from fire risk and
away from sources of heat and ignition

9
ČESKY
POPIS ZAŘÍZENÍ 9
Úvod 9
Komponenty a příslušenství 9
VAROVÁNÍ A UPOZORNĚNÍ 10
URČENÉ POUŽITÍ 10
INDIKACE 10
NEŽÁDOUCÍ ÚČINKY 10
PŘÍPRAVA K POUŽITÍ 10
Příprava k čištění, dezinfekci a sterilizaci 10
Čištění 11
Dezinfekce 11
Sterilizace 11
POSTUP 11
Obecně 11
Příprava před použitím 11
Postup nitrotělní litotrypse 11
ÚDRŽBA 12
ÚČINKY NA ŽIVOTNÍ PROSTŘEDÍ 12
VRÁCENÍ PRODUKTU VÝROBCI 12
ZÁRUKA VÝROBCE 12
ODSTRAŇOVÁNÍ ZÁVAD 13
TECHNICKÁ DATA 14
LMA StoneBreaker™ a sondy 14
Patrona CO2LMA StoneBreaker™ 14
Copyright © The Laryngeal Mask Company Limited, 2009
Všechna práva vyhrazena. Žádná část této publikace nesmí být bez předchozího svolení vydavatele v žádné formě reprodukována, ukládána
do vyhledávacích systémů ani přenášena, a to žádnými prostředky – elektronickými, mechanickými, formou fotokopie, záznamu ani jinak.
LMA, LMA StoneBreaker, logo společnosti The Laryngeal Mask Company Limited a jeho součásti jsou ochrannými známkami společnosti The
Laryngeal Mask Company Limited. Informace uvedené v tomto dokumentu jsou správné v době tiskové uzávěrky. Výrobce si vyhrazuje právo
zdokonalovat nebo měnit výrobky bez předchozího upozornění.

10
LMA StoneBreaker™ POPIS PŘÍSTROJE
Úvod
LMA StoneBreaker™ je přenosný, neelektrický, kompaktní nitrotělní litotryptor určený k fragmentaci kaménků v močových cestách (tj.
v ledvinách, močovodu a močovém měchýři). Jeho hmotnost je přibližně 500 g (včetně sondy) a nepotřebuje žádné externí elektrické nebo
pneumatické přípoje. Je napájen odpojitelnou patronou s vysokotlakým oxidem uhličitým s maximálním přednastaveným provozním tlakem
31 barů. Mechanický ráz vytvořený tímto přístrojem je přenesen ve formě kinetické energie podél sondy do hrotu, který je v přímém kontaktu
s kaménkem, který se má rozdrtit. Výhodou kontaktního přenosu vysokého tlaku je umožnění rychlého rozdrcení, čímž se krátí trvání výkonu.
Samotná sonda se při rozdrcení kaménku pohybuje velmi málo.
Patrona s oxidem uhličitým (CO2) LMA StoneBreaker™ obvykle poskytuje energii nezbytnou k jednomu chirurgickému výkonu. Po perforování
patrony integrovaným šroubovým systémem prochází stlačený plyn přes přednastavený regulátor tlaku v zařízení a po stisknutí spouště se
vytvoří mechanická rázová vlna potřebná k rozdrcení močového kaménku. Expandovaný plyn vyjde ze zařízení přes výpustný port speciální
konstrukce a přes připojenou vypouštěcí linku. Když plyn odejde přes vypouštěcí port, spoušť zapadne zpět do původní polohy a přístroj je
připraven k dalšímu použití.
Jedna plná patrona s oxidem uhličitým LMA StoneBreaker™ umožňuje generování nejméně 80 rázů. Po dokončení chirurgického výkonu se
musí patrona vyjmout z přístroje, aby se z ní vypustil všechen plyn.
LMA StoneBreaker™ se doporučuje používat s endoskopy vybavenými rovným pracovním kanálem.
POZOR: Podle federálních zákonů (USA) je distribuce tohoto přístroje omezena výhradně na prodej lékařem nebo na prodej na
lékařský předpis.
VAROVÁNÍ: Než začnete LMA StoneBreaker™ používat, přečtěte si pečlivě tento návod k použití.
Komponenty a příslušenství
Zařízení LMA StoneBreaker™ je vyrobeno z následujících hlavních komponent. (Viz obrázek 1)
• Spoušť – Generuje mechanické rázové vlny potřebné k rozdrcení konkrementu.
• Čepička sondy – Drží sondu na místě.
• Držák patrony – Slouží k uzamknutí a fixaci polohy patrony s oxidem uhličitým.
• Patrona s oxidem uhličitým – Toto je zdroj energie. Patrony s oxidem uhličitým LMA StoneBreaker™, které jsou sterilizovány gamma zářením, se
dodávají nezávisle na samotném přístroji a sterilní je pouze jejich povrch; plyn uvnitř patrony sterilní není.
POZOR: Po dokončení každého chirurgického výkonu se musí patrona vyjmout z přístroje.
• Vypouštěcí port – Slouží k odvedení vypuštěného plynu z přístroje.
• Vypouštěcí linka – Tato hadička je připojena k vypouštěcímu portu a odvádí vypuštěný plyn z operačního pole.
• Sonda – Zařízení LMA StoneBreaker™ se dodává v samostatném obalu. Sondy jsou na jedno použití a jsou sterilizovány gamma zářením.
Tabulka 1 uvádí sondy LMA StoneBreaker™ aktuálně dostupné k použití s tímto přístrojem. Aktuální sortiment najdete v nejnovějším katalogu
výrobků.
Tabulka 1: Specifikace sond LMA StoneBreaker™
Popis Průměr Celková délka
Sonda 1,0 mm 1,0 mm (3 Fr) 500 mm (19,7 palce)
Sonda 1,0 mm 1,0 mm (3 Fr) 605 mm (23,82 palce)
Sonda 1,6 mm 1,6 mm (4,8 Fr) 500 mm (19,7 palce)
Sonda 1,6 mm 1,6 mm (4,8 Fr) 605 mm (23,82 palce)
Sonda 2,0 mm 2,0 mm (6 Fr) 425 mm (16,73 palce)
Obrázek 1
V y pouštěcí linka Těsnicí
kroužek Sonda
Držák patrony
Patrona s CO
2
Zařízení
Spoušť
Čepička sondy
V y pouštěcí port