Richard Wolf
FRAMELESS - Instrument Set for Neurosurgical Biopsies Instruction Manual
40 Pages
Preview
Page 1
Instruction Manual
- FRAMELESS Instrument set for
neurosurgical biopsies without stereotaxy frame by Assaf 89820.xxxx, 89840.xxxx, 89870.xxxx
GA-B 237 / en / 2010-10 V3.0 / PK18-9297
Important general notes and instructions for use Ensure that this product is used only as intended and described in this instruction manual, by ade quatelytrained and qualified personnel, and that maintenance and repair is only carried out by aut horized specialized technicians. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are met. Reprocess the products before every application and before returning them for repairs as required by the instruction manual in order to protect the patient, user and third parties. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual.
Safety instructions and levels of danger Symbol
Level of danger
WARNING! Failure to observe can result in death or serious injury. CAUTION! Failure to observe can result in slight injury or damage to the product. IMPORTANT! Failure to observe can result in damage to the product or surroundings. NOTE! Tips for optimum use and other useful information.
GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-300 MANUFACTURER [email protected] www.richard-wolf.com
USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: +1 84 79 13 11 13 Telefax: +1 84 79 13 14 88 sales&[email protected] www.richardwolfusa.com
UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com
BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16
FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette 51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33
AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a 1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45
[email protected] www.richard-wolf.at
[email protected] www.richard-wolf.be Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard-wolf.com
0
INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard-wolf.com
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Contents 1
Technical description...
1
2
Intended use...
1
3
Indications and field of use...
2
4
Contraindications...
2
5
Combinations...
3
6 6.1
Illustration... Legend and identification...
4 5
7 7.1 7.1.1 7.2 7.2.1 7.2.1.1 7.2.1.2 7.2.2 7.2.3 7.2.4 7.2.5 7.2.6 7.3 7.3.1 7.3.2 7.3.2.1 7.3.3 7.3.3.1 7.3.3.2 7.3.3.3 7.3.4 7.3.5
Use... Preparation... Assembling the biopsy forceps (7)... Carrying out the biopsy... Inserting the obturator (2) or (4)... Obturator (2) in instrument guide (1.3)... Obturator (4) in catheter guide (3)... Inserting the instrument guide (1.3) or catheter guide (3)... Preparing the control instrument (1) with obturator (2) or (4)... Locking control instrument (1) in clamp and connection to mount (9)... Positioning the neuronavigation marker (X)... Positioning the control instrument (1) using the neuronavigation system... Additional notes and instructions for use... Inserting the control instrument (1) with obturator (2) or (4) into the operating area . . Carrying out an instrument change... Removing the obturator (2) or (4)... Inserting the biopsy instrument into the control instrument (1)... Puncture with puncture cannula with inner part (5)... Biopsy with aspiration biopsy needle with inner needle (6)... Biopsy with biopsy forceps (7)... Completion of the puncture / biopsy... Removing the control instrument (1) from the skullcap and from the universal support arm...
7 8 8 9 9 9 9 10 10 11 12 12 13 13 14 14 15 15 16 18 19
8 8.1 8.1.1 8.2 8.2.1 8.2.2
Checks... Visual check... Biopsy forceps (7)... Function check... Biopsy forceps (7)... Control instrument (1)...
20 20 20 20 21 21
9 9.1 9.2 9.2.1 9.2.2 9.2.3 9.2.4
Reprocessing and maintenance... Disposable biopsy instruments for single use... Disassembly before cleaning... Control instrument (1)... Biopsy forceps (7)... Puncture cannula with inner part (5)... Aspiration biopsy needle with inner needle (6)...
22 22 22 22 23 23 23
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19
I
9.3 9.4 9.5 9.6 9.6.1 9.7 9.8
Illustrations on manual reprocessing... Illustration on machine reprocessing... Assembly before sterilization... Sterilization... Loading schematic for reprocessing basket... Notes on repair / return shipments of products... Reprocessing method...
24 25 25 25 25 25 26
10
Technical data and order data... 34
11
Spare parts and accessories... 35
12 12.1
Operating, storage, transport and shipping conditions... 35 Disposal of product, packaging material and accessories... 35
13
Literature... 36
II
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1
Technical description
The instrument set for neurosurgical biopsies without stereotaxy frame consists of: Control instrument with instrument and catheter guide with distally extendable instrument or catheter guide tube with graduation on the instrument or catheter guide with proximal drive unit with lock screw with receptacle for obturator and biopsy instruments with clamping nut and clamping groove for clamp with distal supporting disc Obturator with atraumatic rod and proximal grip with centering Puncture cannula with inner part Puncture cannula with distal cannula tube and proximal luer fitting Inner part with atraumatic rod and proximal luer lock cap Aspiration biopsy needle with inner needle Aspiration biopsy needle with outer tube with distal window and proximal grip Inner needle with internal tube with distal window and proximal luer fitting Biopsy forceps, modular system with distally spoon-shaped double-articulated jaws with rigid sheath tube and ball catch with proximal forceps handle with overload protection
2
Intended use
The instrument set is used for targeted intracranial placement of biopsy instru ments and catheters in neurosurgery via a surgically created passage. Control instrument with instrument and catheter guide for housing and locking in place biopsy instruments such as puncture cannula, aspiration biopsy needle, biopsy forceps for housing and guiding the neurosurgical catheter for extending the instrument guide tube and for targeted introduction of biopsy instruments into the brain for extending the catheter guide tube and for targeted introduction of the neurosurgical catheter into the brain for housing the clamp and the neuronavigation marker for supporting / securing the control instrument on the skull via a distal sup porting disc Obturator for atraumatic insertion of the instrument or catheter guide tube into the brain Puncture cannula with inner part Puncture cannula for taking neuropathological cerebral tissue for puncturing cysts and abscesses Inner part for atraumatic insertion of the puncture cannula into the brain
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1
Aspiration biopsy needle with inner needle for taking neuropathological cerebral tissue for puncturing cysts and abscesses Biopsy forceps, modular system for taking neuropathological cerebral tissue
3
Indications and field of use
This product is used for neuropathological tissue diagnosis of processes > 1 cm e.g. for differential diagnostics in the case of brain tumors, for the puncturing of cysts and abscesses as well as for the introduction of neurosurgical catheters with an outside dia. Ø ≤ 2.3 mm. Neurosurgical catheters inserted intracranially are used for reducing the intra cranial pressure in the case of a craniocerebral trauma.
NOTE! We recommend reading relevant literature for the planned application. see also section 13 "Literature"
4
Contraindications General contraindications for surgical interventions must be observed taking into account the patient's general condition.
WARNING! Creutzfeldt-Jakob Disease! If the instrument set is used on patients who are suspected of having CJD Creutzfeldt-Jakob disease or vCJD a variant of the Creutzfeldt Jakob Disease BSE Bovine Spongiform Enzephalopathy; the so-called mad cow disease (e.g. Creutzfeldt-Jakob disease) TSE Transmissible Spongiform Enzephalopathy the instruments must be treated in accordance with the country-specific laws and regulations, i.e. according to German laws they must be discarded. On the basis of the latest state-of-the-art and the patient's condition, the surgeon in charge must decide whether the planned application is possible or not. Comply with the laws and regulations valid in your country. For further notes and instruc tions please refer to the latest medical literature. Contraindications directly related to the product are currently unknown. Follow the general contraindications for neurosurgical stereotactic biopsies.
WARNING! When using the instrument set the following hazards may occur: Bleeding in the area of the tissue biopsy (coagulation is not possible). Impaired wound healing, wound infection and infections, transient morbidity and / or in tensification of existing neurological impairment depending on the proximity with eloquent centers, by postoperative edemas / swelling, postbioptic morbidity. There is an increased risk for the patient if: areas of the brain and cerebellum are affected which are located close to large cerebral vessels (e.g. in the area of the arteria cerebri media or arteria basilaris). abnormalism of vessels (AVM, cavernom, aneurysm) are suspected. the intervention is expected to cause neurological deficits (area of the corpus callosum, area of the brain stem, area of the thalamus, medulla oblongata, brain nerves). Please observe any anatomical error sources such as brainshift or the position of the biopsy area (e.g. posterior cranial fossa) when placing the instruments. Incorrectly placed instruments can considerably impair the biopsy result and may lead to inadvertent tissue damage and / or permanent brain damage. Taking into account the items previously mentioned, the surgeon in charge must decide whether the intervention is possible or not.
2
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5
Combinations
The instrument set is used in conjunction with universal supporting arm clamp imaging techniques neuronavigation marker / systems neurosurgical catheter (outside dia. Ø ≤ 2.3 mm) Attach a sterile disposable (single-use) syringe (size: 2 ml)
WARNING! Do not combine products incorrectly! Injuries to the patient, user or third parties as well as damage to the product are possible. Combine the different products only if their intended uses and relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this pro duct. Do not use the catheter guide (3) in conjunction with the following biopsy instru ments: Puncture cannula with inner part (5) Aspiration biopsy needle with inner needle (6) Biopsy forceps (7) Use the catheter guide (3) only for inserting neurosurgical catheters with an outside diameter Ø ≤ 2.3 mm. Do not use the catheter guide (3) for applying or evacuating liquid media. WARNING! Danger of injury if the lot and index numbers of the products used in conjunction do not match! This may result in unintentional tissue damage and / or permanent brain injuries! To ensure the system compatibility of the control instrument (1), the guide unit (1.1) may only be combined with the instrument guide (1.3) or catheter guide (3) if the lot and index numbers match. WARNING! Danger of injury if the instrument set is incorrectly positioned! This may result in unintentional tissue damage and / or permanent brain injuries! Use the instrument set only in combination with a neuronavigation system to gua rantee precise locating and positioning of the instrument set.
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3
6
Illustration 1.1.1
1.1.2 1.1.3
1
1.1
#
10
1.2 1.3
*
1.6
1.5
1.3.1 1.3.2
1.3.3
1.3.4 1.3.5
*
1.3.6
1.4
2.2 2.3
2.1
#
2
* 3.4
3.3
3.2
3.1
3 #
3.5
4.2 4.3 4.4
4.1
4
# 5.3
5.2
5.1
5
# 5.5 5.6
5.4
6.1
6.2 6.3 6.4
6.5
6 6.7 6.8
7.1.1
6.6
6.7
7.1
7.1.2
6.9
#
7.1.3
7.2.2 7.1.4 7.2.1
closed
open
#
6.10
7.2 7.2.3 7.2.4
7 7.1.5 7.1.8 7.1.7
7.1.6
#
8.1 7.2.5
8 7.2.6
9 Fig. 1
4
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6.1
Legend and identification Item
Designation
Item
Designation
1
Control instrument
6
Aspiration biopsy needle with inner needle
1.1
Guide unit, complete
6.1
Outer tube
1.1.1
Supporting disc
6.2
Pin
1.1.2
Clamping nut
6.3
Marking
1.1.3
Clamping groove
6.4
Groove
1.2
Lock screw
6.5
Pin
1.3
Instrument guide
6.6
O-ring
1.3.1
Instrument guide tube
6.7
Receptacle
1.3.2
Graduation
6.8
Cutting window
1.3.3
Guide bushing
6.9
Inner needle
1.3.4
Tab
6.10
Luer fitting
1.3.5
Holes (for aspiration biopsy needle pin)
7
Biopsy forceps, complete
1.3.6
Rack
7.1
Forceps adapter (jaws, complete)
1.4
Drive wheel
7.1.1
Jaw section
1.5
Snap-in screw
7.1.2
Sheath tube
1.6
Spindle (with internal gear)
7.1.3
Position marking
2
Obturator to guide the instruments
7.1.4
Ball catch
2.1
Obturator rod
7.1.5
Pull rod
2.2
Receptacle / grip
7.1.6
Luer connector
2.3
Centering
7.1.7
Rotary knob
3
Catheter guide
7.1.8
Receptacle
3.1
Catheter guide tube
7.2
Handle, complete
3.2
Graduation
7.2.1
Locking sleeve
3.3
Guide bushing
7.2.2
Sliding sleeve
3.4
Luer fitting
7.2.3
Pull relief / overload protection
3.5
Rack
7.2.4
Movable grip
4
Obturator to guide catheters
7.2.5
Fixed grip
4.1
Obturator rod
7.2.6
Finger support
4.2
O-ring
8
Clamp
4.3
Luer Lock cap
8.1
Clamping screw
4.4
Centering
9
Mount
5
Puncture cannula with inner part
10
Protection cap
5.1
Tube
5.2
Receptacle
#
Product no.
5.3
Luer fitting
*
Lot no. - index no.
5.4
Inner part
5.5
O-ring
5.6
Luer Lock cap
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5
Symbol
Designation Attention, Caution!
Follow the instructions for use
REF
Order no. Lot designation
SN
Serial no. Do not reuse. Identification in conformity with medical devices directive 93/42/EEC is only valid if the product and/ or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally marked with the code no. of the notified body (0124).
6
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7
Use WARNING! Reprocessing of disposable items! The life cycle of products marked as disposable items is designed to endure only one single application on a single patient. If disposable items are reprocessed for subsequent use, the product properties may be impaired and / or changed and therefore endanger the patient, user and others. Possible dangers / risk factors are: damage to the product considerable impairment of the function severely increased risk of infection If disposable items are reprocessed for further use, the product responsibility lies with the user or reprocessor, respectively. In this case, the manufacturer can no longer guarantee the safety and per formance of the product. IMPORTANT! The biopsy instruments are disposable items and must only be used once! The following biopsy instruments are designed for single use and are delivered in unsterile condition. Before use, they must be reprocessed and sterilized (see section 9.8): Puncture cannula with inner part (5) Aspiration biopsy needle with inner needle (6) Forceps adapter (7.1) of biopsy forceps (7) Discard the biopsy instruments after use in compliance with the country-specific regulations. WARNING! The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts.
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7
7.1
Preparation
7.1.1
Assembling the biopsy forceps (7)
Check assembly: see sections 7.1.1 and 9.5 Carry out a visual check: see sections 8 and 8.1 Carry out a function check: see section 8.2 Before inserting the instruments into the control instrument (1). After assembling the instruments.
Fig. 2 Hold the handle (7.2) by the sliding sleeve (7.2.2) and the forceps adapter (7.1) by the rotary knob (7.1.7). Insert the forceps adapter (7.1) into the handle (7.2).
7.1.7 7.2.2
7.1
7.2
Fig. 2 Fig. 3 The ball catch (7.1.4) and the pull rod (7.1.5) engage with a click. The movable grip (7.2.4) moves slightly into the direction indicated by the arrow.
6.2.4
Fig. 3 Fig. 4 7.1.3
7.1.1
7.1
7.1.7
NOTE! The rotary knob (7.1.7) serves to rotate the forceps adapter (7.1) to any position required for the application (forceps adapter with 360° fine-tooth snap-in mechanism). The position marker (7.1.3) indicates the opening direction of the jaw sec tion (7.1.1) of the forceps adapter (7.1). Carry out a function check: see sections 8.2 and 8.2.1
Fig. 4
8
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7.2
Carrying out the biopsy WARNING! Danger of injury due to open lock screw (1.2) on the control instrument (1) during the biopsy! Exerting force on the biopsy instrument in direction of the patient can cause inad vertent tissue damage and / or permanent brain damage. Do not exert any force on the biopsy instrument in direction of the patient. Carry out the biopsy only with closed lock screw (1.2). Carry out a skin incision and trepanation of the skullcap at the planned instru ment entry point.
NOTE! The instrument guide (1.3) which can be inserted into the operating area as well as the catheter guide (3) of the control instrument (1) has an outer diameter of 2.7 mm. The physician in charge must decide on the trepanation diameter to be used. 7.2.1
Inserting the obturator (2) or (4)
WARNING! Danger of injury when inserting the instrument guide tube (1.3.1) or catheter guide tube (3.1) in the operating area without the obturator (2) or (4)! This may result in unintentional tissue damage and / or permanent brain injuries! The atraumatic insertion of the instrument (1.3.1) or catheter guide tube (3.1) may only be carried out with the obturator (2) or (4) in place and under neuronavigation and visual control by means of a suitable imaging method. The obturator (2) must be locked in place, the obturator (4) must be screwed in and firmly tightened. 7.2.2
Obturator (2) in instrument guide (1.3) Fig. 5
1.3.4
2
1.3
Push the tab (1.3.4) and insert the obturator (2) in the direction indicated by the arrow as far as it will go. Let go of the tab (1.3.4). The obturator (2) snaps into place. Both components must be securely locked together. Check the components for secure connection.
Fig. 5 7.2.3
Obturator (4) in catheter guide (3) Fig. 6
3.4 4. 3
3
Insert the obturator (4) and screw the luer lock cap (4.3) onto the luer fitting (3.4) in the direction indicated by the arrow. Both components must be securely tightened together. Check the components for secure connection.
4 Fig. 6
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9
7.2.4
Inserting the instrument guide (1.3) or catheter guide (3) Fig. 7 Insert the instrument guide (1.3) or catheter guide (3) with the obturator (2) or (4) and place into the guide unit (1.1) under slight pressure. The rack (1.3.6) engages in the spindle (internal spur gear) (1.6).
1.1
2
1.3
1.6
1.3.6
4
3 Fig. 7 7.2.5
Preparing the control instrument (1) with obturator (2) or (4) Fig. 8(Fig. 8a) Turn the drive wheel (1.4) as indicated by the arrow “A" until the control instru ment (1) with the instrument guide (1.3) or catheter guide (3) and inserted obtura tor (2) or (4) is located at snap-in point position “0". Tighten the lock screw (1.2) by turning as indicated by the arrow marked “STOP". The instrument guide (1.3) or catheter guide (3) must be locked in place. The drive wheel (1.4) must be blocked. Check for secure seating in the “0" position.
1.2
Fig. 8a
2
1.3
1 A
1.4
3
4
Fig. 8b 1.3.1
Fig. 8
(3.1)
WARNING! Danger of injury when inserting the control instrument (1) into the operating area due to the distally projecting instrument guide tube (1.3.1) or catheter guide tube (3.1) (Fig. 8b)! This may result in unintentional tissue damage and / or permanent brain injuries! Insert the control instrument (1) into the operating area only if the obturator (2) or (4) is installed and locked in place. the control instrument (1) is precisely aligned by means of a neuronavigation system and securely locked in place using the clamp (8) and the universal support arm (see section 7.2.6). Observe snap-in position “0".
10
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Fig. 9
IMPORTANT! With the control instrument (1) in snap-in position “0", the respective instrument used is distally flush with the supporting disc (1.1.1). Before the intervention the user must make sure that this is the case and carry out a visual check. The following instruments can be used: Obturator for instrument guide (2) Puncture cannula with inner part (5) Aspiration biopsy needle with inner needle (6) Biopsy forceps (7) Obturator for catheter guide (4)
1.1.1
1
2 5 6 7 4 Fig. 9 Referencing the distal zero point by means of the neuronavigation system. 7.2.6
Locking control instrument (1) in clamp and connection to mount (9) Fig. 10
1.1.2
1.1.3
B
1
A
8.1
8 (a)
9
Turn the clamping nut (1.1.2) in direction of arrow “B“ until the clamping groove (1.1.3) is exposed. Place the clamp (8) into the clamping groove (1.1.3) of the control instrument (1) and lock in place with lock screw (8.1). Tighten the clamping nut (1.1.2) in direction of arrow “A" against the clamp (8). Fasten the clamp (8) to the mount (9) of the universal support arm using wing nuts (a). Also follow the instruction manual of the universal support arm used in combi nation with this product. Check the components for secure connection.
Fig. 10
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11
7.2.7
Positioning the neuronavigation marker (X)
1 1.3
X 1.3.3
2.3
3
4.4
3.3
Fig. 11 Fasten the neuronavigation marker (X) to the guide bushing (1.3.3) or (3.3) of the instrument guide (1.3) or catheter guide (3). The neuronavigation marker (X) in the drawing only serves as an example. The shape and interface of the marker with the control instrument (1) depend on the neuronavigation system used. Follow the instruction manual of the neuronaviation system is in combination with this product. Determine the central axis of the instrument proximally via the centering (2.3) or (4.4) and distally by means of the center of the spherical cap of the obtu rator rod.
Fig. 11 7.2.8
Positioning the control instrument (1) using the neuronavigation system Fig. 12
1
10 1.1.1
Fig. 12
CAUTION! To avoid injuries when supporting the control instrument (1) on the skin, place the protection cap (10) onto the supporting disc (10). When supporting the control instrument (1) directly on the skullcap, use the supporting disc (1.1.1) without the protection cap. WARNING! Danger of injury if the control instrument (1) is incorrectly positioned! This may result in inadvertent tissue damage and / or permanent brain damage! Do not insert the supporting disc (1.1.1) of the control instrument (1) or the protection cap (10) into the cranium.
Fig. 13
1 (b)
Hold the control instrument (1) in one hand and loosen the universal support arm by turning the star grip screw (b) on the central joint clockwise. Preposition the control instrument (1) taking into account the trepanation. Carry out the target alignment of the control instrument using the neuronavigation system, see section 7.2.5.
Fig. 13
(b)
Fig. 14
12
Fig. 14 Lock the working position of the aligned control instrument (1) by turning the star grip screw (b) on the central joint of the universal support arm clockwise. Make sure that the control instrument is securely locked in place. Also follow the instruction manual of the universal support arm used in combi nation with this product.
WARNING! Danger of injury if the support arm is not securely locked in place! This may result in inadvertent tissue damage and / or permanent brain damage! Before inserting the control instrument (1) with obturator (2, 4) in place into the skull, make sure that the universal support arm is securely locked in place and stable.
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7.3
Additional notes and instructions for use
7.3.1
Inserting the control instrument (1) with obturator (2) or (4) into the operating area
WARNING! Danger of injury if the working position of the control instrument (1) has changed! This may result in inadvertent tissue damage and / or permanent brain damage! Check the working position of the control instrument (1) and secure it as described in sections 7.2.7 and 7.2.8. Realign the working position of the control instrument (1) if necessary. Make sure that the control instrument (1) is reliably locked in place with the clamp (8) and the universal support arm. (fig. 10 + fig. 14). During the intervention the clamping nut (1.1.2), the lock screw (8.1), the wing screws (a) -see fig. 10- as well as star grip screw (b) -see fig. 14- must not be ac tuated. Fig. 15
WARNING! Danger of injury when determining the length of extension as well as the posi tioning of the control instrument (1) by means of the graduations! This may result in inadvertent tissue damage and / or permanent brain damage! The graduations (1.3.2)/ (3.2) on the instrument guide (1.3) and on the catheter guide (3) only serve the purpose of orientation and are no measuring equipment. The exact identification and measurement of the length of extension as well as the positioning of the control instrument (1) may only be carried out under control with a neuronavigation system. NOTE! Snap-in points on the drive wheel (1.4) allow you to feel when the instrument guide (1.3) or catheter guide (3.3) is extended or retracted. Turning the drive wheel (1.4) from one snap-in point to the next snap-in point moves the instrument guide (1.3) or catheter guide (3) axially by approx. 2 mm.
Release the lock screw (1.2) against the direction indicated by the “STOP" arrow. Turn the drive wheel (1.4) in the direction of the arrow “A" under the control of a neuronavigation system and insert the control instrument (1) with installed obturator (2) / (4) atraumatically into the biopsy area or catheter target area. After reaching the target position: Tighten the lock screw (1.2) by turning as indicated by the arrow marked “STOP". The instrument guide (1.3) or catheter guide (3) must be locked in place. The drive wheel (1.4) must be blocked.
1.2 1.3.2
2/4
1.3 / 3 operating
1
area
A
1.4
Fig. 15
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13
7.3.2
Carrying out an instrument change
7.3.3
Removing the obturator (2) or (4) Fig. 16
1.3.4
2 3
Push the tab (1.3.4) and remove the obturator (2). If the catheter guide (3) is used: Turn the luer lock cap (4.3) as indicated by the arrow and remove obturator (4).
4 4.3
Fig. 16 WARNING! Danger of injury in case of intracranial instrument change! This may result in inadvertent tissue damage and / or permanent brain damage! Before you insert the instrument (biopsy or catheter)into the control instrument (1), make sure that the instrument guide (1.3) or catheter guide (3) is in the preset posi tion and locked in place by means of the lock screw (1.2). IMPORTANT! Use the instrument guide (1.3) and catheter guide (3) only together with the in struments designed for it and as intended: Instrument guide (1.3) with biopsy instruments (5), (6) and (7). Catheter guide (3) exclusively with the neurosurgical catheter dia. Ø ≤ 2.3 mm. WARNING! Danger of injury if the neurosurgical catheter is introduced uncontrolled! The catheter guide (3) is only used for target alignment. The user decides how deeply the catheter is introduced into the target area. Fig. 17 Carry out an instrument change. If the control instrument (1) is used in conjunction with the catheter guide (3), at the end of the operation the catheter guide (3) must be retracted from the skull as described in section 7.3.8.
1.2
1.3
Fig. 17
14
1
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7.3.4
Inserting the biopsy instrument into the control instrument (1) Keep the required biopsy instrument ready.
7.3.5
Puncture with puncture cannula with inner part (5)
5.4
5.2
5.6
Fig. 18 Insert the inner part (5.4) in the receptacle (5.2) of the puncture cannula (5) and tighten with luer lock cap (5.6). The inner part (5.4) must project atraumatically at the distal end.
5.4 Fig. 18 WARNING! Danger of injury in case of intracranial instrument change! This may result in inadvertent tissue damage and / or permanent brain damage! Before inserting the puncture cannula with inner part (5) into the control instru ment (1), make sure that the instrument guide (1.3) is in the preset position and locked in place with the lock screw (1.2). For this purpose hold the instrument guide (1.3) as shown in Fig. 17 and carry out the instrument change. 1.3.4
1
Fig. 19
5
Introduce the puncture cannula with internal part (5) into the control instrument (1). Push the tab (1.3.4) and insert the puncture cannula with inner part (5) as indi cated by the arrow as far as it will go. Let go of the tab (1.3.4). The receptacle (5.2) snaps into place. Both components must be securely locked together. Check the components for secure connection.
5.2
Fig. 19 5.4
1.3.4 5.3
Fig. 20
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5.6
Fig. 20 Unscrew the luer lock cap (5.6) and remove the inner part (5.4). Attach a sterile disposable (single-use) syringe (size: 2 ml) to the luer fitting (5.3) and puncture the tissue. Push the tab (1.3.4) and remove the puncture cannula (5). Remove the tissue sample from the puncture cannula. Completion of the puncture: see section 7.3.8
5
15
7.3.6
Biopsy with aspiration biopsy needle with inner needle (6)
WARNING! Danger of injury when using a suction pump! This may result in unintentional tissue damage and / or permanent brain injuries! Carry out the biopsy only with a sterile disposable syringe (size: 2 ml). Do not use a suction pump!
6.1
Fig. 21
6.3 6.5 6.4
6.7 6.9 6.8
6.10
6
6.3
Fig. 21
Hold the inner needle (6.9) by the luer fitting (6.10) and introduce into the re ceptacle (6.7) of the outer tube (6.1). The pin (6.5) engages in the groove (6.4). The inner needle (6.9) snaps into the outer tube (6.1). Close the cutting window (6.8): Turn the luer fitting (6.10) in direction of arrow “C" as far as it will go. The marking (6.3) points at “closed".
closed
C
6.10
open
WARNING! Danger of injury in case of intracranial instrument change! This may result in inadvertent tissue damage and / or permanent brain damage! Before inserting the aspiration biopsy needle (6) into the control instrument (1), make sure that the instrument guide (1.3) is on its preset position and is locked in place by the lock screw (1.2). For this purpose hold the instrument guide (1.3) as shown in Fig. 17 and carry out the instrument change.
1 1.3.5 6.2
1.3 1.3.4 6.2 6.3
6.7 6 Fig. 22
16
Fig. 22 Insert the aspiration biopsy needle with inner needle (6) into the control instrument (1). The cutting window (6.8) of the aspiration biopsy needle with inner needle (6) must be closed. The marking (6.3) points at “closed". Push the tab (1.3.4) and introduce the aspiration biopsy needle (6) as indicated by the arrow as far as it will go. The pin (6.2) must engage in the bore (1.3.5) of the instrument guide (1.3). The marking (6.3) on the receptacle (6.7) indicates the position of the pin (6.2). Let go of the tab (1.3). The receptacle (6.7) engages. Both components must be securely locked together. Check the components for secure connection.
NOTE! For the biopsy the aspiration biopsy needle with inner needle (6) can be rotated around the instrument axis in 3 steps of 120° each and engages in the instrument guide (1.3).
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