KARL STORZ ENDOSKOPE
FREITAG Stent Forceps Instructions for Use
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Instructions for use FREITAG Stent Forceps 10510N
10-2020 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.
Table of contents
Table of contents 1 General information... 4 1.1 Read the instructions for use ... 4 1.2 Read the instructions for use of combinable products... 4 1.3 Scope... 4 1.4 Description of warning messages... 4 2 Normal use... 5 2.1 Intended use ... 5 2.2 Indications... 5 2.3 Contraindications... 5 2.4 Target user populations ... 5 2.5 Patient population... 5 3 Safety ... 6 3.1 Serious incidents ... 6 3.2 Unsterile product ... 6 3.3 Correct handling ... 6 3.4 Damaged products ... 6 3.5 Creutzfeldt-Jakob disease ... 6 4 Product description ... 8 4.1 Product overview ... 8 4.2 Ambient conditions ... 8 4.3 Symbols on the packaging ... 9 5 Preparation... 10 5.1 Unpacking the product ... 10 5.2 Inspecting the product... 10 5.3 Assembling the product... 10 6 Application ... 13 6.1 Loading the stent ... 13 6.2 Intubating the stent ... 14 7 Disassembly... 16 7.1 Disassembling the product ... 16 8 Maintenance, servicing, repairs, and disposal... 18 8.1 Produkte instandsetzen ... 18 8.2 Disposing of the product ... 18 9 Accessories and spare parts ... 19 9.1 Spare parts ... 19 10 Subsidiaries... 20
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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General information
1 General information 1.1 Read the instructions for use If the instructions for use are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use carefully and follow all the safety notes and warnings. Keep the instructions for use clearly visible next to the product.
1.2 Read the instructions for use of combinable products If the instructions for use of combinable products are not followed, patients, users, and third parties may be injured or the product may be damaged. Read the instructions for use of the combinable products carefully and follow all the safety notes and warnings.
1.3 Scope These instructions for use are valid for the following products: Catalogue num- Description ber 10510N
FREITAG stent forceps, complete
30526Q
Handle with ratchet
10510AA
Outer sheath
10510B
Forceps insert
10510CA
Pusher
1.4 Description of warning messages To prevent any injury to persons or damage to property, the warnings and safety notes in the instructions for use must be observed. The warning messages describe the following levels of danger. WARNING WARNING Designates a possible imminent risk. If this is not avoided, it could lead to death or serious injuries. CAUTION CAUTION Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries. ATTENTION ATTENTION Designates a possibly harmful situation. If this is not avoided, the products could be damaged.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Normal use
2 Normal use 2.1 Intended use Stent forceps are used for inserting Y-stents into the trachea and positioning them. Stent forceps are designed for transient use in invasive procedures through a body orifice.
2.2 Indications Rigid bronchoscopy is considered indicated if it is indicated in the opinion of the responsible physician.
2.3 Contraindications The use of the bronchoscopes is contraindicated if, in the opinion of the attending physician, the surgical method as such is contraindicated or if the patient is not able to undergo surgery or anesthesia due to his or her general condition. Bronchoscopes must not be used for interventions in direct contact with the central nervous system (CNS) and central cardiovascular system. The following contraindications also apply: Absolute contraindications: –
Untreatable, life-threatening arrhythmia
–
Non-correctable coagulopathy
–
Submaximal oxygenation of the patient before the procedure
–
Acute global respiratory insufficiency (except if patient is already intubated and being ventilated)
Relative contraindications: –
Development of hypoxemia refractory to therapy
–
Coagulation disorder
–
Current anticoagulant therapy
–
Pulmonary hypertension
–
Bronchial hyperresponsiveness
–
Circumstances that give rise to the expectation that the patient may be placed at particular risk by bronchoscopy, such as imminent pneumothorax
Rigid bronchoscopy is also considered contraindicated if intubation by a rigid bronchoscope is impossible due to abnormalities in the patient's maxillofacial or laryngeal area.
2.4 Target user populations The medical device may only be used by doctors and medical assistants with a relevant specialist qualification.
2.5 Patient population There are no restrictions in terms of patient groups for this product.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Safety
3 Safety 3.1 Serious incidents According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that directly or indirectly had, could have had, or could have any of the following consequences (MDR, Art. 2, No. 65 [1]): –
Death of a patient, user, or another person
–
Temporary or permanent serious deterioration in the medical condition of a patient, user, or another person
–
A serious threat to public health The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Unsterile product The product is not sterile when delivered. The use of unsterile products poses a risk of infection for patients, users, or third parties. Before use, reprocess the product in line with the reprocessing instructions.
3.3 Correct handling If the product is not handled correctly, patients, users, and third parties may be injured. Only persons with the necessary medical qualification and who are acquainted with the application of the product may work with it. Check that the product is suitable for the procedure prior to use. Check the product for the following points before and after every use: –
Completeness
–
Good working order
–
Rough surfaces left inadvertently
–
Sharp corners
–
Burred edges
–
Correct assembly of the components
–
Functionality Do not leave broken-off components inside the patient. Do not overload the product with mechanical stress. Do not bend bent products back to their original position.
3.4 Damaged products Damaged products can result in injury to patients, users, or third parties. Before each use, check all components of the product for damage. Do not use damaged products.
3.5 Creutzfeldt-Jakob disease Products that come into contact with the central nervous system can become contaminated by organic residue containing prions. Prions lead to infection with Creutzfeldt-Jakob disease. If Creutzfeld-Jakob disease has been diagnosed or is suspected:
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Safety
Dispose of the product properly and do not continue to use it.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Product description
4 Product description 4.1 Product overview 1
2 10 3 5
4 6
1
FREITAG stent forceps, assembled
2
Forceps insert
3
Outer sheath
4
Slider with guide pin
5
Fixation screw
6
Pusher with half-pipe attached
7
Pusher grip plate
8
Release button for handle lock
9
Handle
10
Handle lock
7
8
9
4.2 Ambient conditions There are no special transport and storage conditions for this product.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Product description
4.3 Symbols on the packaging Symbol
Meaning Manufacturer
Date of manufacture
Medical device
Batch code
Article no.
Number of products in the product packaging
Unique Device Identifier
Unsterile
Consult instructions for use
In accordance with US federal law (21 CFR 801.109), this product may only be sold to or on prescription from a licensed physician. CE conformity mark With this mark, the manufacturer declares the compliance of the products with the applicable regulation (EU) 2017/745. A code number after the CE mark indicates the responsible notified body.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Preparation
5 Preparation 5.1 Unpacking the product 1.
Carefully remove the product and accessories from the packaging.
2.
Check the delivery for missing items and evidence of shipping damage.
3.
In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately.
5.2 Inspecting the product 1.
Inspect products for visible contamination. Do not use contaminated products.
2.
Inspect the products for the following characteristics:
–
Good working order
–
Functionality
–
Correct assembly of the components
–
Completeness Inspect the product for damage, e.g.:
–
Rough surfaces
–
Sharp corners
–
Burred edges
–
Protruding parts
5.3 Assembling the product 1.
Insert the forceps insert fully into the outer sheath and turn the bayonet lock through 90° to lock it. The forceps insert should stay in place when you pull on it. If the forceps insert is not locked properly, you will not be able to complete the next steps.
2.
Open the handle fully and insert the outer sheath with forceps insert as far as it will go into the handle. Make sure that the slider with guide pin is pointing to the right in the direction of use and that the bar fitted underneath the knurled screw is inserted into the guide slot on the handle.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Preparation
3.
The ball end of the forceps insert must be seated correctly inside the handle. If it has been inserted correctly, the handle will close slightly.
4.
Screw the outer sheath tight on the handle with the fixation screw.
5.
Push the guide pin on the slider into the guide slot on the pusher.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Preparation
6.
Starting from proximal, push the pusher half-pipe on to the outer shaft. It must be possible to move the pusher forward and back without resistance.
7.
Close the handle. Press the release button to unlock the handle.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Application
6 Application 6.1 Loading the stent 1.
Press the release button on the handle to unlock the stent forceps.
2.
Close the forceps jaws and insert the forceps into the straight part of the Y-stent. Insert the forceps so that the pusher is sitting in the circular part of the stent and not in the flat part at the bottom.
3.
Once you have inserted the forceps into the stent, open the jaws and push the forceps forward so that the jaws can slide into the two legs of the stent.
4.
Close the forceps and lock the handle.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Application
ð The forceps are now ready for intubation.
6.2 Intubating the stent Once the stent has been loaded, the forceps are inserted under laryngoscopic control. 1.
Just before reaching the bifurcation, the handle is unlocked by pressing the release button and the jaws are opened so that the two legs of the stent can be inserted into the main bronchi.
2.
To detach the stent, press the grip plate on the pusher and pull back on the stent forceps at the same time.
ð The stent is now in place inside the main bronchi. 3.
Close the jaws and remove the forceps from the larynx.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Application
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Disassembly
7 Disassembly 7.1 Disassembling the product 1.
Starting from distal, lift the pusher half-pipe off the outer sheath.
2.
Push the pusher half-pipe up at an angle toward the side located opposite the guide pin of the slider. Remove the half-pipe.
3.
Press the release button to unlock the handle ratchet.
4.
Open the handle as far as it will go.
5.
Turn the fixation screw on the outer sheath to loosen it.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Disassembly
6.
Pull the outer shaft off the handle together with the forceps attachment. The handle must be fully open, otherwise it will not be possible to remove the forceps attachment.
7.
Release the bayonet lock on the forceps insert by turning it through 90° and pull the forceps insert forward and out.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Maintenance, servicing, repairs, and disposal
8 Maintenance, servicing, repairs, and disposal 8.1 Produkte instandsetzen Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. The operations described in this manual are exempt from this rule. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). Contaminated devices may not be shipped. To prevent contact infections and airborne infections, products must first be decontaminated. KARL STORZ reserves the right to send back contaminated products.
8.2 Disposing of the product For disposal, the following measures are necessary: 1.
Decontaminate the products prior to disposal.
2.
Country-specific national laws and regulations must be observed.
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Accessories and spare parts
9 Accessories and spare parts 9.1 Spare parts Item
Order no.
Handle with ratchet
30526Q
Outer sheath
10510AA
Forceps insert
10510B
Pusher
10510CA
Half-shell for outer sheath 105110AA
7909890
Silicone ring for metal outer sheath 105110AA
7944790
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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Subsidiaries
10 Subsidiaries KARL STORZ SE & Co. KG Dr.-Karl-Storz-Straße 34, 78532 Tuttlingen/Germany Postfach 230, 78503 Tuttlingen/Germany Phone: +49 7461 708-0 , Fax: +49 7461 708-105 Email: [email protected]
KARL STORZ SE & Co. KG Representation Office Kęstučio st. 59 / Lenktoji st. 27, 08124 Vilnius, Lithuania Phone: +370 5 272 0448, Mobile: +370 685 67 000 Email: [email protected]
KARL STORZ Endoskope Berlin GmbH Scharnhorststr. 3, 10115 Berlin/Germany Phone: +49 30 3069090, Fax: +49 30 30 19452
KARL STORZ Endoskopi Danmark A/S Skovlytoften 33, 2840 Holte, Denmark Phone: +45 45162600, Fax: +45 45162609 Email: [email protected]
KARL STORZ Endoscopy Canada Ltd. 7171 Millcreek Drive, Mississauga, Ontario L5N 3R3 Canada Phone: +1 905 816-4500, Fax: +1 905 816-4599 Toll free (Canada only) Phone: 1-800-268-4880, Fax: 1-800-482-4198 (Canada only) Email: [email protected] KARL STORZ Endoscopy-America, Inc. 2151 East Grand Avenue, El Segundo, CA 90245-5017, USA Phone: +1 424 218-8100, Fax: +1 424 218-8525 Toll free (USA only) Phone: 800 421-0837, Fax: 800 321-1304 (USA only) Email: [email protected] KARL STORZ Veterinary Endoscopy-America, Inc. 1 South Los Carneros Road, Goleta, CA 93117, USA Phone: +1 805 968-7776, Fax: +1 805 685-2588 Email: [email protected] KARL STORZ Endoscopia Latino-America, Inc. 815 N. W. 57th Avenue, Suite 480, Miami, FL 33126-2042, USA Phone: +1 305 262-8980, Fax: +1 305 262-8986 Email: [email protected] KARL STORZ Endoscopia México S.A. de C.V. Edificio Atlantic, Oficina 3G, Calle D e/ 1ra y 3ra, 10400 Vedado, Havanna, Cuba Phone: +537 836 95 06, Fax: +537 836 97 76 Email: [email protected] KARL STORZ Endoscopia México S.A. de C.V. Av. Ejercito Nacional No. 453 Piso 2, Colonia Granada, Alcaldia Miguel Hidalgo, C.P. 11520 Ciudad de México Phone: +52 (55) 1101 1520 Email: [email protected] KARL STORZ Marketing América Do Sul Ltda. Rua Joaquim Floriano, nº. 413, 20º andar – Itaim Bibi, CEP-04534-011 São Paulo, Brasil Phone: +55 11 3526-4600, Fax: +55 11 3526-4680 Email: [email protected] KARL STORZ Endoscopia Argentina S.A. Zufriategui 627 6° Piso, B1638 CAA - Vicente Lopez, Provincia de Buenos Aires, Argentina Phone: +54 11 4718 0919, Fax: +54 11 4718 2773 Email: [email protected] KARL STORZ Endoskopi Norge AS Stamveien1, 1483 Hagan, Norway Phone: +47 6380 5600, Fax: +47 6380 5601 Email: [email protected] KARL STORZ Endoskop Sverige AB Storsätragränd 14, 127 39 Skärholmen, Sweden Phone: +46 8 505 648 00 Email: [email protected] KARL STORZ Endoscopy Suomi OY Taivaltie 5, 01610 Vantaa, Finland Phone: +358 (0)96824774, Fax: +358 (0)968247755 Email: [email protected]
KARL STORZ Endoscopy (UK) Ltd. 415 Perth Avenue, Slough, Berkshire, SL1 4TQ, United Kingdom Phone: +44 1753 503500, Fax: +44 1753 578124 Email: [email protected] KARL STORZ Endoscopie Nederland B. V. Displayweg 2, 3821 BT Amersfoort, Netherlands Phone: +31 (0)33 4545890 Email: [email protected] KARL STORZ Endoscopy Belgium N. V. Phone: +31 (0)33 4545890 Email: [email protected] KARL STORZ Endoscopie France S. A. S. 12, rue Georges Guynemer, Quartier de l’Europe, 78280 Guyancourt, France Phone: +33 1 30484200, Fax: +33 1 30484201 Email: [email protected] KARL STORZ Endoskop Austria GmbH Landstraßer Hauptstr. 148/1/G1, 1030 Wien, Austria Phone: +43 1 71 56 0470, Fax: +43 1 71 56 0479 Email: [email protected] KARL STORZ Endoscopia Ibérica S. A. Parque Empresarial San Fernando, Edificio Munich – Planta Baja, 28830 Madrid, Spain Phone: +34 91 6771051, Fax: +34 91 6772981 Email: [email protected] KARL STORZ Endoscopia Italia S. r. l. Via dell’Artigianato, 3, 37135 Verona, Italy Phone: +39 045 8222000, Fax: +39 045 8222001 Email: [email protected] KARL STORZ Croatia d.o.o. Capraška 6, 10000 Zagreb, Croatia Phone: +385 1 6406 070, Fax: +385 1 6406 077 Email: [email protected] KARL STORZ Endoskopija d.o.o. Cesta v Gorice 34b, 1000 Ljubljana, Slovenia Phone: +386 1 620 5880, Fax: + 386 1 620 5882 Email: [email protected] KARL STORZ Polska Sp. z o.o. ul. Bojkowska 47, 44-100 Gliwice, Poland Phone: +48 32 706 13 00, Fax: +48 32 706 13 07 Email: [email protected] KARL STORZ Endoszkóp Magyarország Kft. Toberek utca 2. fsz. 17/b, HU-1112 Budapest, Hungary Phone: +36 195 096 31, Fax: +36 195 096 31 Email: [email protected] KARL STORZ Endoscopia Romania srl Str. Prof. Dr. Anton Colorian, nr. 74, Sector 4, 041393 Bukarest, Romania Phone: +40 (0)31 4250800, Fax: +40 (0)31 4250801 Email: [email protected] KARL STORZ Endoskope Greece M.E.P.E.* Patriarhou Grigoriou E’ 34, 54248 Thessaloniki, Greece Phone: +30 2310 304868, Fax: +30 2310 304862 Email: [email protected] *Repair & Service Subsidiary
Instructions for use • FREITAG Stent Forceps • HWL481_EN_V1.0_10-2020_IFU_CE-MDR
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