KARL STORZ ENDOSKOPE
Biopsy Forceps MIP M
NAGELE Modular Minimally Invasive PCNL System Instruction Manual
20 Pages
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Page 1
URO 47 5.5 07/2021-E
A New Generation of Pressure-Controlled PCNL Systems
NAGELE Modular Minimally Invasive PCNL System
In recent years, the concept of minimally invasive percutaneous stone treatment (MIP) has become an accepted standard in miniaturized percutaneous surgery. This has been corroborated in numerous publications.
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The key features of our system – single step dilation; automatic pressure control; stone extraction in the irrigation flow (= vacuum cleaner effect) and the possibility to close the access tract using a gelatin-thrombin matrix in conjunction with ultrasound-guided puncture of the kidney – allow atraumatic and effective stone treatment with fewer complications. The successful outcome of the firstgeneration MIP system created the incentive to meet future challenges in endourology and to switch to a new generation. The second generation of the modular MIP system features 4 instrument sizes to match various indications. This enables urologists to adapt the benefits of minimally invasive PCNL to individual stone sizes and choose the best possible lithotripsy option for each size.
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
“In an era where computed tomography is used to confirm stone-free status, the trend towards endourological stone treatment has become more firmly established. However, the initial euphoria surrounding the introduction of the third generation of flexible uretero-renoscopes has subsided due to limitations of use in routine urological practice. Percutaneous nephrolitholapaxy has proved superior in terms of stone-free rates with regard to the treatment of larger stone burdens and particularly in cases of unfavorable kidney geometry. It also presents an alternative for the treatment of small stones, particularly if the complication rate for the minimally invasive procedure is low but high for primary freedom from calculi.
NAGELE stone concept
Nephrolithiasis
renal pelvis middle and upper calyceal group
inferior calyceal group
≤ 8 mm
> 8 mm
> 15 mm
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
URS flexible
≥ 1000 HU: URS < 1000 HU: ESWL
MIP
Alternative to URS No access to kidney
MIP XS 9.5 Fr.
≤ 15 mm
8-15 mm
10-30 mm MIP
staghorn calculi and > 15 mm
stone size
MIP S 12 Fr.
MIP M 17.5 Fr.
MIP L 24 Fr.
procedure
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Modular Minimally Invasive PCNL System
In contrast to larger nephroscopes, active irrigation is necessary (mandatory when using the XS system but optional for the S-system). Calculi dust following laser fragmentation is suctioned with the irrigation liquid through a ureter catheter. This represents a revolutionary approach in percutaneous stone removal.
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The series of minimally invasive percutaneous instruments now available makes it possible to expand the spectrum of percutaneous stone treatment. This fills the treatment gap for narrow regions that were previously inaccessible for the flexible uretero-renoscope or for impassable calculi following ESWL treatment. In the case of multiple concretions in several calices or if endoscopy is required to control stone elimination, the L system enables the use of flexible nephroscopes.”
Prof. Dr. med. U. NAGELE, Landeskrankenhaus, Hall in Tirol, Austria
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
Contrary to the current trend of using superlatives (ultramini, micro, nano) to denote new PCNL systems, we decided to classify our nephroscopes according to various stone sizes: XS, S, M (previous size) and L. All instrument components associated with a specific nephroscope size bear a clearly visible marking to prevent incorrect use of automatic pressure control and the vacuum cleaner effect so that danger to patients is minimized. The most important innovations are: Enhanced hydrodynamics relative to each nephroscope size; modification of the sheaths via a larger working length for the treatment of adipose patients or patients in the supine position; and the field and angle of view relative to the nephroscope size.
Systematic presentation MIP XS
Irrigation liquid
Irrigation liquid through the sheath
Renal calculus Suction-irrigation pump
Adaptor
Catheter
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
Irrigation liquid through the sheath
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The New Family of MIP Systems and Innovative Features Versatility The right instrument is available for every stone indication. The systems stand out due to their quality and durability.
One-step bougie Following a skin incision, a single dilator can widen the port to allow the sheath to be advanced into the kidney. Telescope bougies or bougies in several sizes are no longer required for individual sheath sizes.
Innovative pressure management
inflow outflow
outflow
Innovative pressure management with MIP XS Due to the small lumen of the MIP XS system, use of the UROMAT E.A.S.I.® pump is recommended for adequate fluid irrigation and suction.
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© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
inflow
outflow
All systems from the MIP series are designed as open systems, i.e. the sheath and telescope are not locked together and there is no second system connection to the system where irrigation liquid can flow off. With the MIP series, the irrigation liquid flows out via the space between the telescope and the operating sheath. Discontinuation of the outflow, which would lead to pressure build-up in the kidney, is not possible.
Efficient stone retrieval with the “vacuum cleaner effect” The hydrodynamic effect (“vacuum cleaner effect”) achieved by the innovative inflow and outflow constellation makes it possible to retrieve stones without grasping forceps or stone baskets. A continuous irrigation flow also enables the residuefree elimination of small stone fragments and calculus dust.
outflow Abfluss inflow Zufluss outflow Abfluss
Direct closure of the access tract Access tracts to the kidney can be directly closed after stone retrieval using a gelatin-thrombin matrix. This eliminates the need for nephrostomy (kidney fistula) in standard PCNL access tracts.
Longer sheaths for the “supine technique”
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
To meet the needs of the emerging market trend for the “supine technique”, KARL STORZ now offers dedicated “supine sheaths” for all MIP systems for the first time. As the supine sheaths can be used with standard telescopes, this offers the user a flexible, yet cost-effective solution.
Use in pediatric applications The MIP system ensures that both adult and pediatric patients benefit from atraumatic treatment thanks to the small sheath diameter in combination with a low-pressure system.
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MIP L – Percutaneous Nephroscope
Special Features:
Specifications:
• Open system allows atraumatic therapy under low-pressure conditions
Instrument sheath: 19.5 Fr. Working channel: 12.4 Fr. for use with instruments up to 11.5 Fr. Telescope: HOPKINS® rod lens telescope Direction of view 12º Length: 22 cm Eyepiece: angled
• One step dilator with a second eccentric channel allows the placement of another guide wire • Large working channel allows the use of rigid standard instruments and lithotripsy probes up to 11.5 Fr. • “Vacuum cleaner effect”
27840KAK
Nephroscope for MIP L, autoclavable
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27840GP
Instrument Port with Sealing System and Quick Release Lock, 1 channel
27500
LUER-Lock Tube Connector, male, tube diameter 9 mm
27502
LUER-Lock Tube Connector, with stopcock, dismantling
27001E
Insertion Aid, for guide wires
30160XA
Silicone Leaflet Washer, diameter 3-5.5 mm, type dome valve, package of 10
30160XB
Seal, package of 10
39501XKL
Wire Tray including: Cleaning Adaptor, for Instrument Port 27840GP
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
The following accessories are included in delivery:
Dilators, Sheaths and Applicators
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
for MIP L
27840AA
One Step Dilator, 23/24 Fr., with central channel and a second eccentric channel for guide wires, for use with 23/24 Fr. Operating Sheaths 27840BA/27840BAS
27840AB
Same, 25/26 Fr., for use with 25/26 Fr. Operating Sheaths 27840BB/27840BBS
27840BA
Operating Sheath, 23/24 Fr., working length 15 cm, for continuous irrigation and suction
27840BB
Same, 25/26 Fr.
27840BAS
Operating Sheath, for the supine position, 23/24 Fr., working length 18 cm, for continuous irrigation and suction
27840BBS
Same, 25/26 Fr.
27840CF
Applicator for Sealant, including sheath and rod, for use with Operating Sheaths 27840BA/27840BB
27840CFS
Applicator for Sealant, for the supine position, including sheath and rod, for use with Operating Sheaths 27840BAS/27840BBS
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MIP M – Percutaneous Nephroscope
Special Features: • One step dilator with a second eccentric channel allows the placement of another guide wire • Large working channel allows the use of rigid standard instruments and large lithotripsy probes up to 5 Fr. • “Vacuum cleaner effect”
Specifications: Instrument sheath: 12 Fr. Working channel: 6.7 Fr. for use with instruments up to 5 Fr. Telescope: Fiber optic system Direction of view 12º Length: 22 cm Eyepiece: angled
Telescope Working/irrigation channel
27830KAK
Nephroscope for MIP M, autoclavable
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27001GP
Instrument Port with Sealing System and Quick Release Lock, 1 channel
27550N
Seal, for Instrument Ports 27001G, 27001GF, 27001GH, 27001GP, package of 10, single use recommended
27500
LUER-Lock Tube Connector, male, tube diameter 9 mm
27502
LUER-Lock Tube Connector, with stopcock, dismantling
27001E
Insertion Aid, for guide wires
39501XK
Wire Tray including: Cleaning Adaptor, for Instrument Ports 27001G/27001GF/27001GH/27001GG
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
The following accessories are included in delivery:
Dilators, Sheaths and Applicators
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
for MIP M
27830AA
One Step Dilator, with central channel for guide wires, for use with 15/16 Fr. Operating Sheaths 27830BA/27830BAS
27830AB
One Step Dilator, with central channel and a second eccentric channel for guide wires, for use with 16.5/19.5 Fr. Operating Sheaths 27830BB/27830BBS
27830AC
One Step Dilator, with central channel for guide wires and distal curved channel for deflection of guide wires, for use with 21/22 Fr. Operating Sheaths 27830BC/27830BCS
27830BA
Operating Sheath, 15/16 Fr., working length 15 cm, for continuous irrigation and suction
27830BB
Same, 16.5/17.5 Fr.
27830BC
Same, 21/22 Fr.
27830BAS
Operating Sheath, for the supine position, 15/16 Fr., working length 18 cm, for continuous irrigation and suction
27830BBS
Same, 16.5/17.5 Fr.
27830BCS
Same, 21/22 Fr.
27830BK
Operating Sheath for Children, 16.5/17.5 Fr., working length 7.5 cm, for continuous irrigation and suction
27830CF
Applicator for Sealant, including sheath and rod, for use with Operating Sheaths 27830BA/27830BB/27830BC
27830CFS
Applicator for Sealant, for the supine position, including sheath and rod, for use with Operating Sheaths 27830BAS/27830BBS/27830BCS
27001GG
Instrument Port with Sealing System and Quick Release Lock, large, 1 channel, for use with accessories up to 6 Fr. (diameter 2 mm) in combination with Nephroscope for MIP M 27830KA
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Optional Accessories
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27840LIK
LASER Hand Instrument, distal tip bent upwards, fixation for LASER fibers and sealing system, working length 35 cm, for use with Nephroscope for MIP L 27840KA and Instrument Port MIP L 27840GP as well as LASER fibers up to diameter 1 mm including: Cleaning Adaptor Seal, package of 10
27290F
Forceps, for grasping stone fragments and coagula, with fenestrated jaws and U-spring handle, 11.5 Fr., length 38 cm, color code: red-black
27290H
Forceps, for grasping larger stones and stone fragments, with triple serrated jaws and U-spring handle, 10.5 Fr., length 38 cm, color code: red-black
27290K
Forceps, for grasping larger stones and stone fragments, with fenestrated jaws and ring handle, double action jaws, 10.5 Fr., length 38 cm, color code: red-black
27290M
Forceps, for grasping larger stones and stone fragments, with serrated jaws and ring handle, double action jaws, 10.5 Fr., length 38 cm, color code: red-black
27294S
Knife, straight, with 3-ring handle, 10.5 Fr., length 38 cm, color code: red-black
27294SK
Knife, only
27294SH
Knife, sickle-shaped, with 3-ring handle, 10.5 Fr., length 38 cm, color code: red-black
27294SB
Knife, only
27840DS
Seal, for Instrument Port 27840GP, bore 0.7 mm, package of 10, for use with thin lithotripsy probes
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
for MIP L
Optional Accessories for MIP M
Forceps for Foreign Body Removal, double action jaws, flexible, 5 Fr., length 40 cm
27830FL
Biopsy Forceps, double action jaws, flexible, 5 Fr., length 40 cm
27830S
Scissors, single action jaws, semiflexible, 5 Fr., working length 40 cm
27830H
Forceps, rigid, for grasping large stones and stone fragments, with triple serrated jaw parts and U-spring handle, 5 Fr., length 36 cm
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
27830FK
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MIP XS/S – Percutaneous Nephroscope Special Features:
Specifications:
• Smallest system in the MIP family
Instrument sheath: 7.5 Fr. Working channel: 2 Fr. Separate irrigation channel: 3 Fr. Telescope: Fiber optic system 6º Direction of view Length: 24 cm angled Eyepiece:
• Working channel with 2 Fr. for guided laser fibers • Separate irrigation channel • Provides an alternative where flexible ureterorenoscopy is not possible
Telescope
Working channel Irrigation channel
27820KAK
Nephroscope for MIP XS/S, autoclavable
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27001G
Instrument Port with Sealing System and Quick Release Lock, 1 channel
27550N
Seal, for Instrument Ports 27001G, 27001GF, 27001GH, 27001GP, package of 10, single use recommended
27500
LUER-Lock Tube Connector, male, tube diameter 9 mm
27502
LUER-Lock Tube Connector, with stopcock, dismantling
27001E
Insertion Aid, for guide probes
39501XK
Wire Tray including: Cleaning Adaptor, for Instrument Ports 27001G/27001GF/27001GH/27001GG
39501XRV
Multiport Bridge
39107ALK
Cleaning Adaptor, for use with small LUER stopcocks
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
The following accessories are included in delivery:
Dilators, Sheaths and Applicators for MIP XS/S Dilator and operating sheaths for MIP XS
27820AA
One Step Dilator, with central channel for guide wires, for use with 8.5/9.5 Fr. Operating Sheaths 27820BA/27820BAS
27820BA
Operating Sheath, 8.5/9.5 Fr., working length 15 cm
27820BAS
Operating Sheath, for the supine position, 8.5/9.5 Fr., working length 18 cm
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
Dilator and operating sheaths for MIP S
27820AB
One Step Dilator, with central channel for guide wires, for use with 11/12 Fr. Operating Sheaths 27820BB/27820BBS
27820BB
Operating Sheath, 11/12 Fr., working length 15 cm, for continuous irrigation and suction
27820BBS
Operating Sheath, for the supine position, 11/12 Fr., working length 18 cm, for continuous irrigation and suction
27820BK
Operating Sheath for Children, 11/12 Fr., working length 7.5 cm, for continuous irrigation and suction
Applicator for MIP XS/S
27820CF
Applicator for Sealant, including sheath and rod, for use with Operating Sheaths 27820BA/27820BB
27820CFS
Applicator for Sealant, for the supine position, including sheath and rod, for use with Operating Sheaths 27820BAS/27820BBS
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UROMAT E.A.S.I.® SCB System Components for MIP XS
UNIT SIDE PATIENT SIDE
Irrigation Tubing Set
031717-10*
Nephroscope for MIP XS/S
* 16
Operating Sheath, 8.5/9.5 Fr., use of UROMAT E.A.S.I.® SCB mandatory
Suction Tubing Set
27820BA
031217-10*
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
27820KAK
UROMAT E.A.S.I.® SCB Pressure-regulated suction and irrigation system Special Features: •
•
•
•
Innovative: Intelligent, pressure-regulated double roller pump (ensures a constant balance between inflow and outflow) Cost-efficient: Continuous comparison of pressure and flow values enables optimal fluid use Convenient: Preset parameters for endo-urological applications Intuitive: Pump parameters can be selected via touch screen
UP410S1
•
•
•
Market-oriented: BOLUS function with adjustable parameters which can be activated via footswitch or touch screen Easier identification: Color coding of the tubing set Blue: Irrigation Red: Suction Can be used for all indications in urology
UROMAT E.A.S.I.® SCB, power supply 100 – 240 VAC, 50/60 Hz, UROMAT E.A.S.I.®: SCB ready, compatible from RUI Release 45 including: SCB Connecting Cable, length 100 cm Basic Tubing Set*, for single use Control Cable
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
Accessories: 031717-10* Irrigation Tubing Set, with two puncture needles, sterile, for single use, package of 10, for use with HYSTEROMAT E.A.S.I.® and UROMAT E.A.S.I.® SCB 031217-10* Suction Tubing Set, sterile, for single use, package of 10, for use with HYSTEROMAT E.A.S.I.® and UROMAT E.A.S.I.® SCB
Specifications Irrigation flow
depending on mode
Irrigation pressure
adjustable 20-200 mmHg
Suction Power supply
Dimensions wxhxd
447 x 155 x 313 mm
100-1800 ml/min suction power
Weight
8.8 kg
100-240 VAC, 50/60 Hz
Certified to
IEC 60601-1, CE acc. to MDD
* 17
© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
Notes
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© KARL STORZ 96132031 URO 47 5.5 07/2021/EW-E
Notes
It is recommended to check the suitability of the product for the intended procedure prior to use. Please note that the described products in this medium may not be available yet in all countries due to different regulatory requirements.
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